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UC Irvine Study Reveals Risks Associated with Direct-to-Consumer Ads for Stem Cell and Exosome COVID-19 Therapies – India Education Diary

Saturday, November 18th, 2023

UC Irvine Study Reveals Risks Associated with Direct-to-Consumer Ads for Stem Cell and Exosome COVID-19 Therapies  India Education Diary

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STEM | Description, Development, & Facts | Britannica

Tuesday, January 31st, 2023

STEM, in full science, technology, engineering, and mathematics, field and curriculum centred on education in the disciplines of science, technology, engineering, and mathematics (STEM). The STEM acronym was introduced in 2001 by scientific administrators at the U.S. National Science Foundation (NSF). The organization previously used the acronym SMET when referring to the career fields in those disciplines or a curriculum that integrated knowledge and skills from those fields. In 2001, however, American biologist Judith Ramaley, then assistant director of education and human resources at NSF, rearranged the words to form the STEM acronym. Since then, STEM-focused curriculum has been extended to many countries beyond the United States, with programs developed in places such as Australia, China, France, South Korea, Taiwan, and the United Kingdom.

In the early 2000s in the United States, the disciplines of science, technology, engineering, and mathematics became increasingly integrated following the publication of several key reports. In particular, Rising Above the Gathering Storm (2005), a report of the U.S. National Academies of Science, Engineering, and Medicine, emphasized the links between prosperity, knowledge-intensive jobs dependent on science and technology, and continued innovation to address societal problems. U.S. students were not achieving in the STEM disciplines at the same rate as students in other countries. The report predicted dire consequences if the country could not compete in the global economy as the result of a poorly prepared workforce. Thus, attention was focused on science, mathematics, and technology research; on economic policy; and on education. Those areas were seen as being crucial to maintaining U.S. prosperity.

Findings of international studies such as TIMSS (Trends in International Mathematics and Science Study), a periodic international comparison of mathematics and science knowledge of fourth and eighth graders, and PISA (Programme for International Student Assessment), a triennial assessment of knowledge and skills of 15-year-olds, reinforced concerns in the United States. PISA 2006 results indicated that the United States had a comparatively large proportion of underperforming students and that the country ranked 21st (in a panel of 30 countries) on assessments of scientific competency and knowledge.

The international comparisons fueled discussion of U.S. education and workforce needs. A bipartisan congressional STEM Education Caucus was formed, noting:

Our knowledge-based economy is driven by constant innovation. The foundation of innovation lies in a dynamic, motivated and well-educated workforce equipped with STEM skills.

While the goal in the United States is a prepared STEM workforce, the challenge is in determining the most-strategic expenditure of funds that will result in the greatest impact on the preparation of students to have success in STEM fields. It is necessary, therefore, to determine the shortcomings of traditional programs to ensure that new STEM-focused initiatives are intentionally planned.

A number of studies were conducted to reveal the needs of school systems and guide the development of appropriately targeted solutions. Concerned that there was no standard definition of STEM, the Claude Worthington Benedum Foundation (a philanthropical organization based in southwestern Pennsylvania) commissioned a study to determine whether proposed initiatives aligned with educator needs. The study, which was administered jointly by Carnegie Mellon University (CMU) and the Intermediate Unit 1 (IU1) Center for STEM Education, noted that U.S. educators were unsure of the implications of STEM, particularly when scientific and technological literacy of all students was the goal. Educators lacked in-depth knowledge of STEM careers, and, as a consequence, they were not prepared to guide students to those fields.

The findings from several studies on educational practices encouraged U.S. state governors to seek methods to lead their states toward the goal of graduating every student from high school with essential STEM knowledge and competencies to succeed in postsecondary education and work. Six states received grants from the National Governors Association to pursue three key strategies: (1) to align state K-12 (kindergarten through 12th grade) standards, assessments, and requirements with postsecondary and workforce expectations; (2) to examine and increase each states internal capacity to improve teaching and learning, including the continued development of data systems and new models to increase the quality of the K-12 STEM teaching force; and (3) to identify best practices in STEM education and bring them to scale, including specialized schools, effective curricula, and standards for Career and Technical Education (CTE) that would prepare students for STEM-related occupations.

In southwestern Pennsylvania, researchers drew heavily on the CMU/IU1 study to frame the regions STEM needs. In addition, a definition for STEM was developed in that region that has since become widely used, largely because it clearly links education goals with workforce needs:

[STEM is] an interdisciplinary approach to learning where rigorous academic concepts are coupled with real-world lessons as students apply science, technology, engineering, and mathematics in contexts that make connections between school, community, work, and the global enterprise enabling the development of STEM literacy and with it the ability to compete in the new economy.

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What is STEM Education? | Live Science

Tuesday, January 31st, 2023

STEM education is a teaching approach that combines science, technology, engineering and math. Its recent successor, STEAM, also incorporates the arts, which have the "ability to expand the limits of STEM education and application," according to Stem Education Guide (opens in new tab). STEAM is designed to encourage discussions and problem-solving among students, developing both practical skills and appreciation for collaborations, according to the Institution for Art Integration and STEAM (opens in new tab).

Rather than teach the five disciplines as separate and discrete subjects, STEAM integrates them into a cohesive learning paradigm based on real-world applications.

According to the U.S. Department of Education (opens in new tab) "In an ever-changing, increasingly complex world, it's more important than ever that our nation's youth are prepared to bring knowledge and skills to solve problems, make sense of information, and know how to gather and evaluate evidence to make decisions."

In 2009, the Obama administration announced the "Educate to Innovate (opens in new tab)" campaign to motivate and inspire students to excel in STEAM subjects. This campaign also addresses the inadequate number of teachers skilled to educate in these subjects.

The Department of Education now offers a number of STEM-based programs (opens in new tab), including research programs with a STEAM emphasis, STEAM grant selection programs and general programs that support STEAM education.

In 2020, the U.S. Department of Education awarded $141 million in new grants and $437 million to continue existing STEAM projects a breakdown of grants can be seen in their investment report (opens in new tab).

STEAM education is crucial to meet the needs of a changing world. According to an article from iD Tech (opens in new tab), millions of STEAM jobs remain unfilled in the U.S., therefore efforts to fill this skill gap are of great importance. According to a report from the U.S. Bureau of Labor Statistics (opens in new tab) there is a projected growth of STEAM-related occupations of 10.5% between 2020 and 2030 compared to 7.5% in non-STEAM-related occupations. The median wage in 2020 was also higher in STEAM occupations ($89,780) compared to non-STEAM occupations ($40,020).

Between 2014 and 2024, employment in computer occupations is projected to increase by 12.5 percent between 2014 and 2024, according to a STEAM occupation report (opens in new tab). With projected increases in STEAM-related occupations, there needs to be an equal increase in STEAM education efforts to encourage students into these fields otherwise the skill gap will continue to grow.

STEAM jobs do not all require higher education or even a college degree. Less than half of entry-level STEAM jobs require a bachelor's degree or higher, according to skills gap website Burning Glass Technologies (opens in new tab). However, a four-year degree is incredibly helpful with salary the average advertised starting salary for entry-level STEAM jobs with a bachelor's requirement was 26 percent higher than jobs in the non-STEAM fields.. For every job posting for a bachelor's degree recipient in a non-STEAM field, there were 2.5 entry-level job postings for a bachelor's degree recipient in a STEAM field.

What separates STEAM from traditional science and math education is the blended learning environment and showing students how the scientific method can be applied to everyday life. It teaches students computational thinking and focuses on the real-world applications of problem-solving. As mentioned before, STEAM education begins while students are very young:

Elementary school STEAM education focuses on the introductory level STEAM courses, as well as awareness of the STEAM fields and occupations. This initial step provides standards-based structured inquiry-based and real-world problem-based learning, connecting all four of the STEAM subjects. The goal is to pique students' interest into them wanting to pursue the courses, not because they have to. There is also an emphasis placed on bridging in-school and out-of-school STEAM learning opportunities.

Middle school At this stage, the courses become more rigorous and challenging. Student awareness of STEAM fields and occupations is still pursued, as well as the academic requirements of such fields. Student exploration of STEAM-related careers begins at this level, particularly for underrepresented populations.

High school The program of study focuses on the application of the subjects in a challenging and rigorous manner. Courses and pathways are now available in STEAM fields and occupations, as well as preparation for post-secondary education and employment. More emphasis is placed on bridging in-school and out-of-school STEAM opportunities.

Much of the STEAM curriculum is aimed toward attracting underrepresented populations. There is a significant disparity in the female to male ratio when it comes to those employed in STEAM fields, according to Stem Women (opens in new tab). Approximately 1 in 4 STEAM graduates is female.

Ethnically, people from Black backgrounds in STEAM education in the UK have poorer degree outcomes and lower rates of academic career progression compared to other ethnic groups, according to a report from The Royal Society (opens in new tab). Although the proportion of Black students in STEAM higher education has increased over the last decade, they are leaving STEAM careers at a higher rate compared to other ethnic groups.

"These reports highlight the challenges faced by Black researchers, but we also need to tackle the wider inequalities which exist across our society and prevent talented people from pursuing careers in science." President of the Royal Society, Sir Adrian Smith said.

Asian students typically have the highest level of interest in STEAM. According to the Royal Society report in 2018/19 18.7% of academic staff in STEAM were from ethnic minority groups, of these groups 13.2% were Asian compared to 1.7% who were Black.

If you want to learn more about why STEAM is so important check out this informative article from the University of San Diego (opens in new tab). Explore some handy STEAM education teaching resources courtesy of the Resilient Educator (opens in new tab). Looking for tips to help get children into STEAM? Forbes (opens in new tab) has got you covered.

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Science, Technology, Engineering, and Math, including Computer Science – ed

Monday, January 23rd, 2023

Today, the U.S. Department of Education (Department) will host the YOU Belong in STEM National Coordinating Conference in Washington, D.C. as a key initiative for the Biden-Harris Administration. The Raise the Bar: STEM Excellence for All Students initiative is designed to strengthen Science, Technology, Engineering and Mathematics (STEM) education nationwide. This new Biden-Harris Administration initiative will help implement and scale equitable, high-quality STEM education for all students from PreK to higher educationregardless of background to ensure their 21st century career readiness and global competitiveness.

Research shows how a sense of belonging in rich and rigorous classrooms is directly correlated to students long-term academic success. Moreover, the Departments Civil Rights Data Collection continues to demonstrate that students of color and students with disabilities are disproportionately excluded from learning opportunities in STEM, said U.S. Deputy Secretary of Education Cindy Marten. Today, we are saying unequivocally to all students and educators that they belong in STEM and that they deserve to have rigorous and relevant educational experiences that inspire and empower them to reach their full potential as productive, contributing members of our nations workforce.

In support of the initiative and its goals, the Department has:

The U.S. Department of Education invited STEM education entities to make bold commitment(s) to advance STEM education in America. We encourage you to consider the following parameters in developing your commitment:

In just three weeks, over 90 organizations and even individual educators from across the country have come forward to offer specific commitments to enhance STEM education for all. These commitments range from local grassroots efforts to initiatives that are national in scope. Those interested in joining this movement may submit a commitment here by December 31, 2022.

Albert Einstein Distinguished Educator Fellowship ProgramAmerican Federation of TeachersAmerican Institute of MathematicsAmerican University Game CenterAssociation of Science and Technology CentersBattelle/STEMxBeyond100KBlack Rocket ProductionsBreakthrough CollaborativeBrightmoor Urban Training LLCBrightSpark, Inc.Brown Toy BoxBrownSTEMCalifornia State University, Office of the ChancellorCarnegie Corporation of New YorkCenter for Energy Workforce DevelopmentCenter for Family Math at NAFSCECenter of Science and Industry (COSI)Challenger CenterChicago Public Schools - Pershing Magnet SchoolCode.orgCodeVCommunity Resources for ScienceComputer Science Teachers AssociationData Science 4 EveryoneDiscoverEEast Syracuse Minoa CSD STEM Learning EcoystemEdGE @ TERCEducate MaineEnCorps, Inc.FULL STEAM AHEAD LLC TNGGUSDHispanics for STEM IDRA & Lead of the Alamo STEM EcosystemIntel ArizonaInternational Technology and Engineering Educators AssociationIntrepid Sea, Air & Space Museum ISS National Laboratory JASON LearningKC STEM AllianceKids' Chemical Solutions Learning BladeLG Technical Services MDCPS/ TeachforAmericaMeharry School of Applied Computational SciencesMMSA/ Maine Mathematics and Science AllianceMSD of MartinsvilleNational Children's Museum

National Girls Collaborative ProjectNational Network of State Teachers of the YearNational Science Teaching AssociationNational Education AssociationNew Jersey Tutoring Corps IncNew York Hall of ScienceNI (formerly National Instruments)Niswonger Foundation / STEM.LDNorth Mason School DistrictNortheast Florida Regional STEM2 Hub, Inc. Ohio Afterschool NetworkOld Forge Elementary SchoolOut TeachOverdeck Family FoundationPartnerships in Education and Resilience (PEAR)Pennsylvania Statewide STEM EcosystemPhiladelphia Education Fund/Philadelphia STEM EcosystemPS ScienceS2TEM Centers SC/South Carolina Coalition of Mathematics and ScienceSAE FoundationScience is ElementarySHPE (Society of Hispanic Professional Engineers)Smithsonian Science Education Center, Smithsonian InstitutionSociety of Women EngineersSourcewell South Jersey STEM Innovation & PartnershipSTEM Next Opportunity FundSTEMpressarial INC.STEMSSTEMS4Girls, Inc. StudentTagpros Children InternationalTechbridge Girls Thaddeus Stevens College of TechnologyThe LEGO GroupThe New Mexico Out-of-School Time Network (NMOST)The University of Texas at Austin/ Texas Advanced Computing Center (TACC)The UTeach Institute at The University of Texas at AustinU.S. DOE Office of Elementary and Secondary EducationUnity Technologies University of HoustonUSD 457 and Kansas State Department of EducationU.S. Patent and Trademark OfficeWyoming Afterschool Alliance365 Productions Inc

BackgroundDepartment Offices that Support STEMExamples of the Department's discretionary grants that can support STEM Grant Applicant ResourcesCall for Peer ReviewersAmerica's Strategy for STEM EducationSecretary's STEM PriorityU.S. Department of Education STEM NewsletterArchived STEM NewslettersSTEM Education BriefingsUpcoming STEM BriefingsArchived STEM BriefingsResourcesOther Communications ToolsOther Federal Agency STEM WebsitesDepartment STEM Contacts

In an ever-changing, increasingly complex world, it's more important than ever that our nation's youth are prepared to bring knowledge and skills to solve problems, make sense of information, and know how to gather and evaluate evidence to make decisions. These are the kinds of skills that students develop in science, technology, engineering, and math, including computer sciencedisciplines collectively known as STEM/CS. If we want a nation where our future leaders, neighbors, and workers can understand and solve some of the complex challenges of today and tomorrow, and to meet the demands of the dynamic and evolving workforce, building students' skills, content knowledge, and literacy in STEM fields is essential. We must also make sure that, no matter where children live, they have access to quality learning environments. A child's zip code should not determine their STEM literacy and educational options.

Office of Planning, Evaluation, and Policy Development (OPEPD)Office of Career, Technical, and Adult Education (OCTAE)Office of Elementary and Secondary Education (OESE)Office of Special Education and Rehabilitative Services (OSERS)Office of Postsecondary Education (OPE)Office of Non-Public Education (ONPE)Office of Educational Technology (OET)Office of English Language Acquisition (OELA)Institute of Educational Sciences (IES)White House InitiativesFederal Student Aid (FSA)Office of Communications and Outreach (OCO)

Below are investments made in FY 2020:

You can search for open discretionary grant opportunities or reach out to the Department's STEM contacts noted below. The Forecast of Funding Opportunities lists virtually all Department discretionary grant programs for FY 2021.

The Department published in spring 2020 two new grant applicant resources. These resources were developed to (1) provide an overview of the discretionary (or competitive) grants application process and (2) offer more details intended to be used by prospective applicants, including new potential grantees. These support one of the Secretary's new administrative priorities on New Potential Grantees that was published in March 2020. They can also be found under the "Other Grant Information" on the ED's Grants webpage.

The Department is seeking peer reviewers for our Fiscal Year 2021 competitive/discretionary grant season, including in the STEM/CS areas (among others). The Federal Register notice spotlights the specific needs of the Office of Elementary and Secondary Education (OESE), the Office of Postsecondary Education (OPE), and the Office of Special Education and Rehabilitative Services (OSERS). The How to Become a Peer Reviewer slide deck provides additional information and next steps.

The STEM Education Strategic Plan, Charting a Course for Success: America's Strategy for STEM Education, published in December 2018, sets out a federal strategy for the next five years based on a vision for a future where all Americans will have lifelong access to high-quality STEM education and the United States will be the global leader in STEM literacy, innovation, and employment. It represents an urgent call to action for a nationwide collaboration with learners, families, educators, communities, and employersa "North Star" for the STEM community as it collectively charts a course for the Nation's success. The Department is an active participant in each of the interagency working groups focused on implementation of the Plan.

Learn more about what the Department and other federal agencies are doing to implement the plan in these progress reports:

Progress Reports

October 2019December 2020December 2021

Secretary Cardona finalized his six priorities for use in agency discretionary grant programs; equitable access to rigorous STEM, including computer science, experiences is noted in Priority 2. The Department also issued a revised set of common instructions for grant applicants.

In February 2020, the Department created the U.S. Department of Education STEM Newsletter. Please go to our newsletter subscription page to sign-up.

January 2023October/November 2022September 2022August 2022July 2022May 2022April 2022March 2022February 2022January 2022December 2021November 2021October 2021October 2021 AddendumSeptember 2021August 2021July 2021June 2021 May 2021 April 2021 January 2021 December 2020 November 2020 October 2020September 2020August 2020July 2020June 2020May 2020April 2020March 2020February 2020

The STEM Education Briefings are live-streamed, close-captioned and archived for your convenience.

There are no upcoming STEM briefings at this time.

November 15, 2022 Public Health and STEM with CDC (presentation slides [MS PowerPoint, 40MB])September 16, 2022 The Pathway to Convergence (presentation slides [MS PowerPoint, 77MB])July 19, 2022 Girls in STEM(21stCCLC Summer Symposium)April 26, 2022 Learning with NASA is Out of this WorldMarch 25, 2022 Science: Call to Action (presentation slides [MS PowerPoint, 22MB])February 24, 2022 Rural STEM Education (presentation slides [MS PowerPoint, 125MB])January 19, 2022 - Think Globally, Teach Locally (presentation slides [PDF, 10MB])December 9, 2021 Environmental LiteracyNovember 30, 2021 Energizing STEM (presentation slides [PDF, 6.7MB])October 15, 2021 Data Literacy (presentation slides [PDF, 12.6MB])July 28, 2021 Advanced Manufacturing: Industry of the Future (presentation slides [PDF, 11.3MB])May 4, 2021 Summertime STEM (presentation slides [PDF, 18.3MB])March 25, 2021 Differing Abilities in STEM, featuring Dr. Temple Grandin (presentation slides [PDF, 13.7MB])February 2021 Inspiring STEM Interest (presentation slides [PDF, 3.7MB])December 2020 New Frontiers in K-12 Computer Science (presentation slides [PDF, 12.7MB])November 2020 Federal STEM Strategic Plan: 2 Years Later (presentation slides [PDF, 15.49MB]).October 2020 Invention Education (presentation slides [PDF, 13.13MB])September 2020 STEM Teacher Preparation (presentation slides [PDF, 3.5MB])August 2020 Cybersecurity Education (presentation slides [PDF, 10.5MB])July 2020 Early Math (presentation slides [PDF, 2.37MB])June 2020 Distance LearningFebruary 2020 STEM After SchoolJanuary 2020 STEAM: Arts Supporting STEMDecember 2019 Family Engagement in STEMNovember 2019 The STEM Opportunity IndexOctober 2019 Early Engineering Education and State EffortsSeptember 2019 Recruiting and Retaining 100K STEM Teachers in 10 YearsJuly 2019 What Do We Know about Computer Science Education?

Assisting Students Struggling with Mathematics: Intervention in the Elementary GradesDesigning and Delivering Career Pathways at Community CollegesLearning in a Pandemic WebinarFall 2020 Back-to-School Success StoriesCOVID-19 Information and Resources for Schools and School PersonnelESEA, IDEA, and Perkins ResourcesCollege Scorecard updated again on 1/15/21Exploring Career Options FSAWork-Based LearningStackable Credentials that lead to careersCross-agency teacher resourcesIES data and statistics, research and evaluation, and tools for educatorsOut of School STEM InitiativesThe ED Games Expo "Goes Virtual" to Support Distance LearningSTEM Data Story A Leak in the STEM Pipeline: Taking Algebra EarlyCTE Data Story Bridging the Skills Gap: Career and Technical Education in High SchoolSTEM Spotlights Parent and Family Digital Learning GuideEarly Learning: STEM Math VideoKeep Calm and Connect All Student OET Blog SeriesK-12 Practitioners' CircleSTEM Innovation for Inclusion in Early Education (STEMI2E2) Center and OSEP's Early Learning NewsletterA Transition Guide to Postsecondary Education and Employment for Students and Youth with DisabilitiesCTE Research CenterCivil Rights Data CollectionDepartment's Data Strategy

Homeroom BlogPress ReleasesTwitterNewsletter Subscriptions

The following are federal agencies that the Department collaborates with to support the aims of the STEM Education Strategic Plan (see above section for more details) and support the Department's stakeholders.

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What Does STEM Stand For? Definition, Degrees and More

Monday, January 23rd, 2023

Just because you have an interest in STEM (we assume you do since youre this far into the article), does that mean you have to give up on other pursuits? The humanities, which include everything from philosophy to anthropology to literature, might be an important part of who you are as a person too.

Thats why many in education have advocated for the inclusion of the arts in STEM education. And so the acronym STEAM was born!

Arts and humanities play an important part in many STEM careers. Its one thing, for instance, to design a phone thats more functional than the rest. Yet that phone may not sell as well without an attractive design that resonates with potential customers.

STEM fields help us find concrete answers to difficult questions; yet many problems do not have clear-cut solutions. Engineers working with self-driving cars, for example, have to reckon with difficult philosophical decision-making when designing these vehicles. If a self-driving car is about to hit a pedestrian, should it steer off the road, harming the driver but sparing the pedestrian? Its not a question that can be answered through mathematical equations or clever engineering.

Its to address problems like these that the humanities have been integrated into STEM education. The arts help workers in STEM fields figure out issues of subjectivity when objectivity wont cut it.

Understanding what STEM means, and how it figures into your education, can help you figure out the educational path thats right for you. Do you like working with computers to solve day-to-day business problems? Then an online IT degree might be a great choice. Maybe youd rather work out complex theoretical equations and discover the secrets of the universe. Get started with an introductory course in calculus.

Wherever you are in your educational journey, and wherever your interests lie, theres a STEM path for you!

Women have their own take on STEM. Check out how women working in tech overcome challenges to succeed.

Get started in your STEM journey with a technology degree from University of Phoenix!

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What Is STEM? – Definition & Resources for Teachers

Monday, January 23rd, 2023

STEM might win the award for the most talked about education buzzword of the last 10 years or so. Its gotten to the point where, similar to the organic and low fat labels in the food industry, STEM could mean very little if you see it on toys or educational products. So how do we talk intelligently about STEM education and where it needs to go? The first step is understanding the history of this term and what it means for schools.

STEM stands for science, technology, engineering, and math. STEM curriculum blends those subjects in order to teach 21st-century skills, or tools students need to have if they wish tosucceed in the workplace of the future. The idea is that in order to be prepared for jobs and compete with students from different parts of the world, students here in the US need to be able to solve problems, find and use evidence, collaborate on projects, and think critically. Skills, the thinking goes, that are taught in those subjects.

Still, STEM can be hard to define. Its such a popular term that it means a lot of different things to a lot of different people. Although the science (biology, chemistry, etc.) and math (algebra, calculus, etc.) parts of the abbreviation might be easy to figure out, the technology and engineering parts might be less clear. Technology includes topics such as computer programming, analytics, and design. Engineering can include topics like electronics, robots, and civil engineering. The key term, when talking about STEM, is integration. STEM curriculum intentionally melds these disciplines. Its a blended approach that encourages hands-on experience and gives students the chance to gain and apply relevant, real-world knowledge in the classroom.

Like most things, STEM was around before it had an actual name. But STEM wasnt known as STEM until Dr. Judith Ramalay coined the term. While working as director at the National Science Foundation in the early 2000s, Ramalay came up with the term to describe the blended curriculum she and her team were developing. Referred to as SMET at first,which, if we had to guess, might also be the name of a Scandinavian dessert, Ramalay changed the acronym around because she didnt like how SMET sounded. So we (thankfully) got STEM.

STEM grew in popularity due to the concerns of politicians and other leaders that US students were not keeping pace with other students and would thus not be prepared to work in the fastest-growing career sectors, which generally fall under the STEM umbrella. In 2009, the Obama administration announced its plan to support STEM curriculum that would both encourage and train students to pursue careers in those fields. It would also support teachers to, well, teach students those skills. That effort has been formalized in many ways, including using the language of STEM in Next Gen Science Standards. So, teachers everywhere are expectedby parents, administrators, etc.to provide a STEM-rich curriculum.

We get it. STEM sounds like a lot. Theres a big difference between teaching students to remember to carry the one and teaching them how to code. But there are simple, unintimidating, and effective ways to implement a STEM curriculum in your classroom that has nothing to do with teaching R2D2 to dab.

If you teach younger students, create an environment that encourages observation and asking questions that begin with Why ? or How does ? Go on nature walks. Sing Old MacDonald Had a Farm and use it as a springboard to think about the ecosystem of a farm. Explore how simple classroom machines, like a stapler, work. Above all, its important to help students to get a solid foundation. Make sure they are fluent in basic skills like addition and subtraction, measurement, or identifying shapes.

For upper elementary and middle school students, consider project-based learning. Pose problems that students can relate to, can be solved in different ways, and let students work together and provide evidence of their thinking. Most importantly, students need to be able to pull from their knowledge of different subjects as they work toward an answer. The Association for Middle School Education, for example, provides several great scenarios that promote STEM learning. For instance, if there was an outbreak of illness at a carnival, how would your students solve that problem? Or, even more broadly, how might they create a community of the future?

High school students, especially juniors or seniors, should definitely be thinking about college and beyond. Do you have a student or two who might make a great crime scene investigator? How might you bring a version of the board game Clue into the classroom? Help students use forensic science and their investigative skills to determine whodunit and the cause of death. What math skills do they need to know to come up with the analytics to predict the next NBA champion? Or, have students run analytics for previous seasons and compare their results to what really happened.

Theres no I in team. Theres also no A in STEMuntil recently. Asking questions, using evidence, and working well with others to solve problems are not skills taught only in the hard sciences. Excellent humanities and social science curricula teach these tools as well. And they engage students creativity and imagination. As such, theres a growing movement to incorporate more arts and humanities subjects into STEM curriculum. This is a great co-teaching opportunity. How might your English class join up with science students in the previously mentioned Clue scenario? Maybe they can write a backstory. Perhaps another group of students can design and build a scale version of the crime scene. There are lots of possibilities. Above all, whether its STEM or STEAM, your plan should encourage cross-curricular activities and inspire students to use and gain knowledge in exciting ways.

WeAreTeachers has some excellent STEM and STEAM resources. Check out some of them:

How do you STEM your curriculum? Come share in ourWeAreTeachers HELPLINE groupon Facebook.

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What Is STEM? - Definition & Resources for Teachers

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Science, technology, engineering, and mathematics – Wikipedia

Monday, January 23rd, 2023

Group of academic disciplines

Science, technology, engineering, and mathematics (STEM) is an umbrella term used to group together the distinct but related technical disciplines of science, technology, engineering, and mathematics. The term is typically used in the context of education policy or curriculum choices in schools. It has implications for workforce development, national security concerns (as a shortage of STEM-educated citizens can reduce effectiveness in this area) and immigration policy.[1]

There is no universal agreement on which disciplines are included in STEM; in particular whether or not the science in STEM includes social sciences, such as psychology, sociology, economics, and political science. In the United States, these are typically included by organizations such as the National Science Foundation (NSF),[1] the Department of Labor's O*Net online database for job seekers,[2] and the Department of Homeland Security.[3] In the United Kingdom, the social sciences are categorized separately and are instead grouped together with humanities and arts to form another counterpart acronym HASS (Humanities, Arts, and Social Sciences), rebranded in 2020 as SHAPE (Social Sciences, Humanities and the Arts for People and the Economy).[4][5]

In the early 1990s, the acronym STEM was used by a variety of educators in preference to SMET, including Charles E. Vela, the founder and director of the Center for the Advancement of Hispanics in Science and Engineering Education (CAHSEE).[6][7][8] Moreover, the CAHSEE started a summer program for talented under-represented students in the Washington, DC area called the STEM Institute. Based on the program's recognized success and his expertise in STEM education,[9] Charles Vela was asked to serve on numerous NSF and Congressional panels in science, mathematics and engineering education;[10] it is through this manner that NSF was first introduced to the acronym STEM. One of the first NSF projects to use the acronym was STEMTEC, the Science, Technology, Engineering and Math Teacher Education Collaborative at the University of Massachusetts Amherst, which was founded in 1998.[11]In 2001, at the urging of Dr. Peter Faletra, the Director of Workforce Development for Teachers and Scientists at the Office of Science, the acronym was adopted by Rita Colwell and other science administrators in the National Science Foundation (NSF). The Office of Science was also an early adopter of the STEM acronym.[12]

The Australian Curriculum, Assessment and Reporting Authority 2015 report entitled, National STEM School Education Strategy, stated that "A renewed national focus on STEM in school education is critical to ensuring that all young Australians are equipped with the necessary STEM skills and knowledge that they must need to succeed."[30] Its goals were to:

Events and programs meant to help develop STEM in Australian schools include the Victorian Model Solar Vehicle Challenge, the Maths Challenge (Australian Mathematics Trust),[31] Go Girl Go Global[31] and the Australian Informatics Olympiad.[31]

Canada ranks 12th out of 16 peer countries in the percentage of its graduates who studied in STEM programs, with 21.2%, a number higher than the United States, but lower than France, Germany, and Austria. The peer country with the greatest proportion of STEM graduates, Finland, has over 30% of its university graduates coming from science, mathematics, computer science, and engineering programs.[32]

SHAD is an annual Canadian summer enrichment program for high-achieving high school students in July. The program focuses on academic learning particularly in STEAM fields.[33]

Scouts Canada has taken similar measures to their American counterpart to promote STEM fields to youth. Their STEM program began in 2015.[34]

In 2011 Canadian entrepreneur and philanthropist Seymour Schulich established the Schulich Leader Scholarships, $100 million in $60,000 scholarships for students beginning their university education in a STEM program at 20 institutions across Canada. Each year 40 Canadian students would be selected to receive the award, two at each institution, with the goal of attracting gifted youth into the STEM fields.[35] The program also supplies STEM scholarships to five participating universities in Israel.[36]

To promote STEM in China, the Chinese government issued a guideline in 2016 on national innovation-driven development strategy, instructing that by 2020, China should become an innovative country; by 2030, it should be at the forefront of innovative countries; and by 2050, it should become a technology innovation power.[citation needed]

In February 2017, the Ministry of Education in China announced they would officially add STEM education to the primary school curriculum, which is the first official government recognition of STEM education. And later, in May 2018, the launching ceremony and press conference for the 2029 Action Plan for China's STEM Education was held in Beijing, China. This plan aims to allow as many students to benefit from STEM education as possible and equip all students with scientific thinking and the ability to innovate. In response to encouraging policies by the government, schools in both public and private sectors around the country have begun to carry out STEM education programs.[citation needed]

However, to effectively implement STEM curricula, full-time teachers specializing in STEM education and relevant content to be taught are needed. Currently, China lacks qualified STEM teachers, and a training system is yet to be established.[citation needed]

Several Chinese cities have taken bold measures to add programming as a compulsory course for elementary and middle school students. This is the case of the city of Chongqing.[citation needed]

Several European projects have promoted STEM education and careers in Europe. For instance, Scientix[37] is a European cooperation of STEM teachers, education scientists, and policymakers. The SciChallenge[38] project used a social media contest and the student-generated content to increase motivation of pre- university students for STEM education and careers. The Erasmus programme project AutoSTEM[39] used automata to introduce STEM subjects to very young children.

In Finland LUMA Center is the leading advocate for STEM oriented education. In the native tongue luma stands for "luonnontieteellis-matemaattinen" (lit. adj. "scientific-mathematical"). The short is more or less a direct translation of STEM, with engineering fields included by association. However unlike STEM, the term is also a portmanteau from lu and ma.

The name of STEM in France is industrial engineering sciences (sciences industrielles or sciences de l'ingnieur). The STEM organization in France is the association UPSTI.[clarification needed]

STEM education has not been promoted among the local schools in Hong Kong until recent years. In November 2015, the Education Bureau of Hong Kong released a document titled Promotion of STEM Education,[40] which proposes strategies and recommendations on promoting STEM education.

India is next only to China with STEM graduates per population of 1 to 52. The total fresh STEM graduates were 2.6 million in 2016.[41] STEM graduates have been contributing to the Indian economy with well paid salaries locally and abroad since last two decades. The turnaround of Indian economy with comfortable foreign exchange reserves is mainly attributed to the skills of its STEM graduates.

In Nigeria, The Association of Professional Women Engineers Of Nigeria (APWEN) has involved girls between the ages of 12 to 19 in science based courses in other for them to pursue science based courses in the higher institutions of learning. National Science Foundation (NSF) In Nigeria has made conscious efforts to encourage girls to innovate, invent and build it through the 'invent it, build it challenge' program sponsored by NNPC.[42]

STEM subjects are taught in Pakistan as part of electives taken in the 9th and 10th grade, culminating in Matriculation exams. These electives are: pure sciences (Physics, Chemistry, Biology), mathematics (Physics, Chemistry, Maths) and computer science (Physics, Chemistry, Computer Science). STEM subjects are also offered as electives taken in the 11th and 12th grade, more commonly referred to as first and second year, culminating in Intermediate exams. These electives are: FSc pre-medical (Physics, Chemistry, Biology), FSc pre-engineering (Physics, Chemistry, Maths) and ICS (Physics/Statistics, Computer Science, Maths). These electives are intended to aid students in pursuing STEM-related careers in the future by preparing them for the study of these courses at university.

A STEM education project has been approved by the government[43] to establish STEM labs in public schools. The Ministry of Information Technology and Telecommunication has collaborated with Google to launch Pakistan's first grassroots level Coding Skills Development Program,[44] based on Google's CS First Program, a global initiative aimed at developing coding skills in children. The aim of the program is to develop applied coding skills using gamification techniques for children between the ages of 9 and 14.

The KPITBs Early Age Programming initiative,[45] established in the province of Khyber Pakhtunkhwa, has been successfully introduced in 225 Elementary and Secondary Schools. There are many private organizations working in Pakistan to introduce STEM education in schools.

In the Philippines, STEM is a two-year program and strand that is used for Senior High School (Grade 11 and 12), as signed by the Department of Education or DepEd. The STEM strand is under the Academic Track, which also include other strands like ABM, HUMSS, and GAS.[46][47] The purpose of STEM strand is to educate students in the field of science, technology, engineering, and mathematics, in an interdisciplinary and applied approach, and to give students advance knowledge and application in the field. After completing the program, the students will earn a Diploma in Science, Technology, Engineering, and Mathematics. In some colleges and universities, they require students applying for STEM degrees (like medicine, engineering, computer studies, etc.) to be a graduate of STEM, if not, they will need to enter a bridging program.

In Qatar, AL-Bairaq is an outreach program to high-school students with a curriculum that focuses on STEM, run by the Center for Advanced Materials (CAM) at Qatar University. Each year around 946 students, from about 40 high schools, participate in AL-Bairaq competitions.[48] AL-Bairaq make use of project-based learning, encourages students to solve authentic problems, and inquires them to work with each other as a team to build real solutions.[49][50] Research has so far shown positive results for the program.[51]

STEM is part of the Applied Learning Programme (ALP) that the Singapore Ministry of Education (MOE) has been promoting since 2013, and currently, all secondary schools have such a programme. It is expected that by 2023, all primary schools in Singapore will have an ALP. There are no tests or exams for ALPs. The emphasis is for students to learn through experimentation they try, fail, try, learn from it and try again. The MOE actively supports schools with ALPs to further enhance and strengthen their capabilities and programmes that nurtures innovation and creativity.

The Singapore Science Centre established a STEM unit in January 2014, dedicated to igniting students passion for STEM. To further enrich students learning experiences, their Industrial Partnership Programme (IPP) creates opportunities for students to get early exposure to the real-world STEM industries and careers. Curriculum specialists and STEM educators from the Science Centre will work hand-in-hand with teachers to co-develop STEM lessons, provide training to teachers and co-teach such lessons to provide students with an early exposure and develop their interest in STEM.

In 2017, Thai Education Minister Dr Teerakiat Jareonsettasin said after the 49th Southeast Asia Ministers of Education Organisation (SEAMEO) Council Conference in Jakarta that the meeting approved the establishment of two new SEAMEO regional centres in Thailand. One would be the STEM Education Centre, while the other would be a Sufficient Economy Learning Centre.

Teerakiat said that the Thai government had already allocated Bt250 million over five years for the new STEM centre. The centre will be the regional institution responsible for STEM education promotion. It will not only set up policies to improve STEM education, but it will also be the centre for information and experience sharing among the member countries and education experts. According to him, This is the first SEAMEO regional centre for STEM education, as the existing science education centre in Malaysia only focuses on the academic perspective. Our STEM education centre will also prioritise the implementation and adaptation of science and technology.[52]

The Institute for the Promotion of Teaching Science and Technology has initiated a STEM Education Network. Its goals are to promote integrated learning activities and improve student creativity and application of knowledge, and to establish a network of organisations and personnel for the promotion of STEM education in the country.[53]

Turkish STEM Education Task Force (or FeTeMMFen Bilimleri, Teknoloji, Mhendislik ve Matematik) is a coalition of academicians and teachers who show an effort to increase the quality of education in STEM fields rather than focussing on increasing the number of STEM graduates.[54][55]

In the United States, the acronym began to be used in education and immigration debates in initiatives to begin to address the perceived lack of qualified candidates for high-tech jobs. It also addresses concern that the subjects are often taught in isolation, instead of as an integrated curriculum.[56] Maintaining a citizenry that is well versed in the STEM fields is a key portion of the public education agenda of the United States.[57] The acronym has been widely used in the immigration debate regarding access to United States work visas for immigrants who are skilled in these fields. It has also become commonplace in education discussions as a reference to the shortage of skilled workers and inadequate education in these areas.[58] The term tends not to refer to the non-professional and less visible sectors of the fields, such as electronics assembly line work.

Many organizations in the United States follow the guidelines of the National Science Foundation on what constitutes a STEM field. The NSF uses a broader definition of STEM subjects that includes subjects in the fields of chemistry, computer and information technology science, engineering, geosciences, life sciences, mathematical sciences, physics and astronomy, social sciences (anthropology, economics, psychology and sociology), and STEM education and learning research.[1][59]The NSF is the only American federal agency whose mission includes support for all fields of fundamental science and engineering, except for medical sciences.[60] Its disciplinary program areas include scholarships, grants, fellowships in fields such as biological sciences, computer and information science and engineering, education and human resources, engineering, environmental research and education, geosciences, international science and engineering, mathematical and physical sciences, social, behavioral and economic sciences, cyberinfrastructure, and polar programs.[59]

Although many organizations in the United States follow the guidelines of the National Science Foundation on what constitutes a STEM field, the United States Department of Homeland Security (DHS) has its own functional definition used for immigration policy.[61] In 2012, DHS or ICE announced an expanded list of STEM designated-degree programs that qualify eligible graduates on student visas for an optional practical training (OPT) extension. Under the OPT program, international students who graduate from colleges and universities in the United States can stay in the country and receive up to twelve months of training through work experience. Students who graduate from a designated STEM degree program can stay for an additional seventeen months on an OPT STEM extension.[62][63]

An exhaustive list of STEM disciplines does not exist because the definition varies by organization. The U.S. Immigration and Customs Enforcement lists disciplines including[64] architecture, physics, actuarial science, chemistry, biology, mathematics, applied mathematics, statistics, computer science, computational science, psychology, biochemistry, robotics, computer engineering, electrical engineering, electronics, mechanical engineering, industrial engineering, information science, information technology, civil engineering, aerospace engineering, chemical engineering, astrophysics, astronomy, optics, nanotechnology, nuclear physics, mathematical biology, operations research, neurobiology, biomechanics, bioinformatics, acoustical engineering, geographic information systems, atmospheric sciences, educational/instructional technology, software engineering, and educational research.

By cultivating an interest in the natural and social sciences in preschool or immediately following school entry, the chances of STEM success in high school can be greatly improved.[citation needed]

STEM supports broadening the study of engineering within each of the other subjects, and beginning engineering at younger grades, even elementary school. It also brings STEM education to all students rather than only the gifted programs. In his 2012 budget, President Barack Obama renamed and broadened the "Mathematics and Science Partnership (MSP)" to award block grants to states for improving teacher education in those subjects.[65]

In the 2015 run of the international assessment test the Program for International Student Assessment (PISA), American students came out 35th in mathematics, 24th in reading and 25th in science, out of 109 countries. The United States also ranked 29th in the percentage of 24-year-olds with science or mathematics degrees.[66]

STEM education often uses new technologies such as RepRap 3D printers to encourage interest in STEM fields.[67]

In 2006 the United States National Academies expressed their concern about the declining state of STEM education in the United States. Its Committee on Science, Engineering, and Public Policy developed a list of 10 actions. Their top three recommendations were to:

The National Aeronautics and Space Administration also has implemented programs and curricula to advance STEM education in order to replenish the pool of scientists, engineers and mathematicians who will lead space exploration in the 21st century.[68]

Individual states, such as California, have run pilot after-school STEM programs to learn what the most promising practices are and how to implement them to increase the chance of student success.[69] Another state to invest in STEM education is Florida, where Florida Polytechnic University,[70] Florida's first public university for engineering and technology dedicated to science, technology, engineering and mathematics (STEM), was established.[71] During school, STEM programs have been established for many districts throughout the U.S. Some states include New Jersey, Arizona, Virginia, North Carolina, Texas, and Ohio.[72][73]

Continuing STEM education has expanded to the post-secondary level through masters programs such as the University of Maryland's STEM Program[74] as well as the University of Cincinnati.[75]

In the United States, the National Science Foundation found that the average science score on the 2011 National Assessment of Educational Progress was lower for black and Hispanic students than white, Asian, and Pacific Islanders.[76] In 2011, eleven percent of the U.S. workforce was black, while only six percent of STEM workers were black.[77] Though STEM in the U.S. has typically been dominated by white males, there have been considerable efforts to create initiatives to make STEM a more racially and gender diverse field.[78] Some evidence suggests that all students, including black and Hispanic students, have a better chance of earning a STEM degree if they attend a college or university at which their entering academic credentials are at least as high as the average student's.[79] However, there is criticism that emphasis on STEM diversity has lowered academic standards.[80]

Although women make up 47% of the workforce[81] in the U.S., they hold only 24% of STEM jobs. Research suggests that exposing girls to female inventors at a young age has the potential to reduce the gender gap in technical STEM fields by half.[82] Campaigns from organizations like the National Inventors Hall of Fame aimed to achieve a 50/50 gender balance in their youth STEM programs by 2020.

In the State of the Union Address on January 31, 2006, President George W. Bush announced the American Competitiveness Initiative. Bush proposed the initiative to address shortfalls in federal government support of educational development and progress at all academic levels in the STEM fields. In detail, the initiative called for significant increases in federal funding for advanced R&D programs (including a doubling of federal funding support for advanced research in the physical sciences through DOE) and an increase in U.S. higher education graduates within STEM disciplines.

The NASA Means Business competition, sponsored by the Texas Space Grant Consortium, furthers that goal. College students compete to develop promotional plans to encourage students in middle and high school to study STEM subjects and to inspire professors in STEM fields to involve their students in outreach activities that support STEM education.

The National Science Foundation has numerous programs in STEM education, including some for K12 students such as the ITEST Program that supports The Global Challenge Award ITEST Program. STEM programs have been implemented in some Arizona schools. They implement higher cognitive skills for students and enable them to inquire and use techniques used by professionals in the STEM fields.

Project Lead The Way (PLTW) is a provider of STEM education curricular programs to middle and high schools in the United States. Programs include a high school engineering curriculum called Pathway To Engineering, a high school biomedical sciences program, and a middle school engineering and technology program called Gateway To Technology. PLTW programs have been endorsed by President Barack Obama and United States Secretary of Education Arne Duncan as well as various state, national, and business leaders.[citation needed]

The Science, Technology, Engineering, and Mathematics (STEM) Education Coalition[83] works to support STEM programs for teachers and students at the U. S. Department of Education, the National Science Foundation, and other agencies that offer STEM-related programs. Activity of the STEM Coalition seems to have slowed since September 2008.

In 2012, the Boy Scouts of America began handing out awards, titled NOVA and SUPERNOVA, for completing specific requirements appropriate to scouts' program level in each of the four main STEM areas. The Girl Scouts of the USA has similarly incorporated STEM into their program through the introduction of merit badges such as "Naturalist" and "Digital Art".[84]

SAE is an international organization, solutions'provider specialized on supporting education, award and scholarship programs for STEM matters, from pre-K to the college degree.[85] It also promotes scientific and technologic innovation.

[86]The eCybermission is a free, web-based science, mathematics and technology competition for students in grades six through nine sponsored by the U.S. Army. Each webinar is focused on a different step of the scientific method and is presented by an experienced eCybermission CyberGuide. CyberGuides are military and civilian volunteers with a strong background in STEM and STEM education, who are able to provide valuable insight into science, technology, engineering, and mathematics to students and team advisers.

STARBASE is a premier educational program, sponsored by the Office of the Assistant Secretary of Defense for Reserve Affairs. Students interact with military personnel to explore careers and make connections with the "real world." The program provides students with 2025 hours of stimulating experiences at National Guard, Navy, Marines, Air Force Reserve and Air Force bases across the nation.

SeaPerch is an innovative underwater robotics program that trains teachers to teach their students how to build an underwater remotely operated vehicle (ROV) in an in-school or out-of-school setting. Students build the ROV from a kit composed of low-cost, easily accessible parts, following a curriculum that teaches basic engineering and science concepts with a marine engineering theme.

NASAStem is a program of the U.S. space agency NASA to increase diversity within its ranks, including age, disability, and gender as well as race/ethnicity.[87]

The America COMPETES Act (P.L. 11069) became law on August 9, 2007. It is intended to increase the nation's investment in science and engineering research and in STEM education from kindergarten to graduate school and postdoctoral education. The act authorizes funding increases for the National Science Foundation, National Institute of Standards and Technology laboratories, and the Department of Energy (DOE) Office of Science over FY2008FY2010. Robert Gabrys, Director of Education at NASA's Goddard Space Flight Center, articulated success as increased student achievement, early expression of student interest in STEM subjects, and student preparedness to enter the workforce.

In November 2012 the White House announcement before congressional vote on the STEM Jobs Act put President Obama in opposition to many of the Silicon Valley firms and executives who bankrolled his re-election campaign.[88] The Department of Labor identified 14 sectors that are "projected to add substantial numbers of new jobs to the economy or affect the growth of other industries or are being transformed by technology and innovation requiring new sets of skills for workers."[89] The identified sectors were as follows: advanced manufacturing, Automotive, construction, financial services, geospatial technology, homeland security, information technology, Transportation, Aerospace, Biotechnology, energy, healthcare, hospitality, and retail.

The Department of Commerce notes STEM fields careers are some of the best-paying and have the greatest potential for job growth in the early 21st century. The report also notes that STEM workers play a key role in the sustained growth and stability of the U.S. economy, and training in STEM fields generally results in higher wages, whether or not they work in a STEM field.[90]

In 2015, there were around 9.0 million STEM jobs in the United States, representing 6.1% of American employment. STEM jobs were increasing around 9% percent per year.[91] Brookings Institution found that the demand for competent technology graduates will surpass the number of capable applicants by at least one million individuals.

According to Pew Research Center, a typical STEM worker earns two-thirds more than those employed in other fields.[92]

According to the 2014 US Census "74 percent of those who have a bachelor's degree in science, technology, engineering and math commonly referred to as STEM are not employed in STEM occupations."[93][94]

In September 2017, a number of large American technology firms collectively pledged to donate $300 million for computer science education in the U.S.[95]

PEW findings revealed in 2018 that Americans identified several issues that hound STEM education which included unconcerned parents, disinterested students, obsolete curriculum materials, and too much focus on state parameters. 57 percent of survey respondents pointed out that one main problem of STEM is lack of students' concentration in learning.[96]

The recent National Assessment of Educational Progress (NAEP) report card[97] made public technology as well as engineering literacy scores which determines whether students have the capability to apply technology and engineering proficiency to real-life scenarios. The report showed a gap of 28 points between low-income students and their high-income counterparts. The same report also indicated a 38-point difference between white and black students.[98]

The Smithsonian Science Education Center (SSEC) announced the release of a five-year strategic plan by the Committee on STEM Education of the National Science and Technology Council on December 4, 2018. The plan is entitled "Charting a Course for Success: America's Strategy for STEM Education."[99] The objective is to propose a federal strategy anchored on a vision for the future so that all Americans are given permanent access to premium-quality education in Science, Technology, Engineering, and Mathematics. In the end, the United States can emerge as world leader in STEM mastery, employment, and innovation. The goals of this plan are building foundations for STEM literacy; enhancing diversity, equality, and inclusion in STEM; and preparing the STEM workforce for the future.[100]

The 2019 fiscal budget proposal of the White House supported the funding plan in President Donald Trump's Memorandum on STEM Education which allocated around $200 million (grant funding) on STEM education every year. This budget also supports STEM through a grant program worth $20 million for career as well as technical education programs.[101]

In Vietnam, beginning in 2012 many private education organizations have STEM education initiatives.

In 2015, the Ministry of Science and Technology and Lin minh STEM organized the first National STEM day, followed by many similar events across the country.

in 2015, Ministry of Education and Training included STEM as an area needed to be encouraged in national school year program.

In May 2017, Prime Minister signed a Directive no. 16[102] stating: "Dramatically change the policies, contents, education and vocational training methods to create a human resource capable of receiving new production technology trends, with a focus on promoting training in science, technology, engineering and mathematics (STEM), foreign languages, information technology in general education; " and asking "Ministry of Education and Training (to): Promote the deployment of science, technology, engineering and mathematics (STEM) education in general education program; Pilot organize in some high schools from 2017 to 2018.

Women constitute 47% of the U.S. workforce, and perform 24% of STEM-related jobs.[103] In the UK women perform 13% of STEM-related jobs (2014).[104] In the U.S. women with STEM degrees are more likely to work in education or healthcare rather than STEM fields compared with their male counterparts.

The gender ratio depends on field of study. For example, in the European Union in 2012 women made up 47.3% of the total, 51% of the social sciences, business and law, 42% of the science, mathematics and computing, 28% of engineering, manufacturing and construction, and 59% of PhD graduates in Health and Welfare.[105]

In a study from 2019 it was shown that part of the success of women in STEM depends on the way women in STEM are viewed. In a study that researched grants given based primarily on project versus primarily based on the project lead there was almost no difference in the evaluation between projects from men or women when evaluated on project, but those evaluated mainly on the project leader showed that projects headed by women were given grants four percent less often.[106]

Improving the experiences of women in STEM is a major component of increasing the number of women in STEM. One part of this includes the need for role models and mentors who are women in STEM. Along with this, having good resources for information and networking opportunities can improve women's ability to flourish in STEM fields.[107]

People identifying within the group LGBTQ+ have faced discrimination in STEM fields throughout history. Few were openly queer in STEM; however, a couple of well-known people are Alan Turing, the father of computer science, and Sara Josephine Baker, American physician and public-health leader.[108]

Despite recent changes in attitudes towards LGBTQ+ people, discrimination still permeates throughout STEM fields.[109][110] A recent study has shown that gay men are less likely to have completed a bachelor's degree in a STEM field and to work in a STEM occupation.[111][112] Along with this, those of sexual minorities overall have been shown to be less likely to remain in STEM majors throughout college.[110] Another study concluded that queer people are more likely to experience exclusion, harassment and other negative impacts while in a STEM career while also having fewer opportunities and resources available to them.[113]

Multiple programs and institutions are working towards increasing the inclusion and acceptance of LGBTQ+ people in STEM. In the US, the National Organization of Gay and Lesbian Scientists and Technical Professionals (NOGLSTP) has organized people to address homophobia since the 1980s and now promotes activism and support for queer scientists.[114] Other programs, including 500 Queer Scientists and Pride in STEM, function as visibility campaigns for LGBTQ+ people in STEM worldwide.[114][115]

The focus on increasing participation in STEM fields has attracted criticism. In the 2014 article "The Myth of the Science and Engineering Shortage" in The Atlantic, demographer Michael S. Teitelbaum criticized the efforts of the U.S. government to increase the number of STEM graduates, saying that, among studies on the subject, "No one has been able to find any evidence indicating current widespread labor market shortages or hiring difficulties in science and engineering occupations that require bachelor's degrees or higher", and that "Most studies report that real wages in manybut not allscience and engineering occupations have been flat or slow-growing, and unemployment as high or higher than in many comparably-skilled occupations." Teitelbaum also wrote that the then-current national fixation on increasing STEM participation paralleled previous U.S. government efforts since World War II to increase the number of scientists and engineers, all of which he stated ultimately ended up in "mass layoffs, hiring freezes, and funding cuts"; including one driven by the Space Race of the late 1950s and 1960s, which he wrote led to "a bust of serious magnitude in the 1970s."[116]

IEEE Spectrum contributing editor Robert N. Charette echoed these sentiments in the 2013 article "The STEM Crisis Is a Myth", also noting that there was a "mismatch between earning a STEM degree and having a STEM job" in the United States, with only around 14 of STEM graduates working in STEM fields, while less than half of workers in STEM fields have a STEM degree.[117]

Economics writer Ben Casselman, in a 2014 study of post-graduation earnings in the United States for FiveThirtyEight, wrote that, based on the data, science should not be grouped with the other three STEM categories, because, while the other three generally result in high-paying jobs, "many sciences, particularly the life sciences, pay below the overall median for recent college graduates."[118]

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Stem Definition & Meaning – Merriam-Webster

Monday, January 23rd, 2023

1

specifically : a primary plant axis that develops buds and shoots instead of roots

: a plant part (such as a branch, petiole, or stipe) that supports another (such as a leaf or fruit)

: the complete fruiting stalk of a banana plant with its bananas

2

: the main upright member at the bow of a ship

3

especially : a fundamental line from which others have arisen

4

5

: something held to resemble a plant stem: such as

: a main or heavy stroke of a letter

: the short perpendicular line extending from the head of a musical note

: the part of a tobacco pipe from the bowl outward

: a shaft of a watch used for winding

transitive verb

1

: to make headway against (something, such as an adverse tide, current, or wind)

2

: to check or go counter to (something adverse)

transitive verb

1

: to remove the stem from

2

: to make a stem for (something, such as an artificial flower)

intransitive verb

transitive verb

1

: to stop or dam up (something, such as a river)

intransitive verb

1

also : to become checked or stanched

2

: to slide the heel of one ski or of both skis outward usually in making or preparing to make a turn

2

science, technology, engineering, and mathematics

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November: labblood-study | News and features – University of Bristol

Monday, November 7th, 2022
  1. November: labblood-study | News and features  University of Bristol
  2. Lab-grown blood cells give hope to donor patients after they are successfully transfused  Daily Mail
  3. Lab-grown red blood cells transfused into people in world-leading UK trial  Express
  4. Lab-grown red blood cells are transfused into a person for the first time in the world  CableFreeTV
  5. View Full Coverage on Google News

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November: labblood-study | News and features - University of Bristol

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Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the…

Monday, November 7th, 2022

Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the Treatment of Type 1 Diabetes  PR Newswire

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Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the...

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Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and…

Monday, November 7th, 2022

Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and Distinguished Portfolio  PR Newswire

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Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and...

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Type 2 Diabetes Stem Cell Therapy – Top U.S. Stem Cell …

Saturday, January 1st, 2022

TruStem Cell Therapy provides access to treatment that utilizes a patients stem cells isolated from their own bone marrow. There are multiple inherent benefits afforded by the utilization of bone marrow derived stem cells asBone marrow (BM) and bone marrow components function in various diverse, innate therapeutic capacities.

Hematopoietic stem cells (HSCs), found within BM, are the bodys source of most cells found in the peripheral or circulating blood. These include red blood cells and white blood cells (such as monocytes). Evidence suggests that BM-derived monocytes may act to improve certain chronic inflammatory auto-immune conditions conditions.

In addition to HSCs, mesenchymal stem cells (MSCs) are also contained within BM. Evidence suggests MSCs can enter the circulating blood during injury and have been shown to readily home to areas of injury or inflammation. Once at these damaged tissue sites, MSCs can exert both protective cellular and immunomodulatory effects believed to be critical in many auto-immune conditions.

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Cancer Drug Approvals from 2021 That Patients May Have Missed – Curetoday.com

Saturday, January 1st, 2022

From immunotherapy combinations to treatments for the complications that can arise from stem cell transplantation, the year 2021 brought countless Food and Drug Administration (FDA) approvals that are changing patients lives.

CURE made a roundup of some of the most-read FDA approvals throughout the year. They were:

1. FDA Approves Welireg for Several Cancers Associated With VHL Disease

In August, the FDA approved Welireg (belzutifan) for adults with von Hippel-Lindau (VHL)-related kidney cancer, central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. The drug led to response rates in 49% of patients with kidney cancer, 63% of CNS hemangioblastoma and 83% of pNET.

2. FDA Approves Keytruda/Chemo for Triple-Negative Breast Cancer

Keytruda (pembrolizumab), an immunotherapy agent, plus chemotherapy was approved for patients with high-risk, early-stage triple-negative breast cancer (TNBC) an advancement that has the potential to change the treatment paradigm, according to Dr. Joyce OShaughnessy.

3. FDA Approves Yescarta for Third-Line Treatment of Relapsed or Refractory Follicular Lymphoma

This March, the FDA approved Yescarta (axicabtagene ciloleucel), for pretreated indolent (low-grade) follicular lymphoma the first CAR-T cell therapy to be approved in this patient population. The ZUMA-5 clinical trial led to the drugs approval and showed that 91% of patients with relapsed/refractory follicular lymphoma were in continued remission at 18 months post treatment.

4. FDA Approves Radiation Therapy for Outpatient Setting in Liver Cancer Subtype

TheraSphere Yttrium-90 (Y-90) Glass Microspheres was granted FDA approval for patients with hepatocellular carcinoma the most common type of liver cancer. The approval is notable because it allowed an option for this patient population to be treated without being hospitalized.

5. FDA Approves Rezurock for Chronic Graft-Versus-Host Disease After Two Prior Lines of Therapy

Individuals with chronic graft-versus-host disease (GVHD) that was previously treated with at least two other therapy now have a new treatment option Rezurock (belumosudil) thanks to the FDAs approval of the agent this summer. Rezurock has shown robust and durable responses across the spectrum of (chronic graft-versus-host disease) and is safe and well tolerated, allowing patients to stay on therapy and achieve meaningful benefit from treatment, said Dr. Corey Cutler.

6. FDA Approves First CAR-T Cell Therapy for Multiple Myeloma

In March, the FDA approved the first cell-based gene therapy Abecma (idecabtagene vicleucel) for the treatment of adults with multiple myeloma who did not respond to at least four lines of therapy or whose disease returned after the same number of therapies.

7. FDA Approves Cabometyx For Thyroid Cancer Subset

Cabometyx (cabozantinib) was given the greenlight by the FDA for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer.

8. FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

The agency approved Lumakras (sotorasib), the first targeted therapy for patients with non-small cell lung cancer and a KRAS G12C mutation, whose disease progressed after one systemic therapy.

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Late effects in survivors of high-risk neuroblastoma following stem cell transplant with and without total body irradiation – DocWire News

Saturday, January 1st, 2022

This article was originally published here

Pediatr Blood Cancer. 2021 Dec 31:e29537. doi: 10.1002/pbc.29537. Online ahead of print.

ABSTRACT

BACKGROUND: Neuroblastoma is the most common extracranial solid tumor in children. Those with high-risk disease are treated with multimodal therapy, including high-dose chemotherapy, stem cell transplant, radiation, and immunotherapy that have led to multiple long-term complications in survivors. In the late 1990s, consolidation therapy involved myeloablative conditioning including total body irradiation (TBI) with autologous stem cell rescue. Recognizing the significant long-term toxicities of exposure to TBI, more contemporary treatment protocols have removed this from conditioning regimens. This study examines an expanded cohort of 48 high-risk neuroblastoma patients to identify differences in the late effect profiles for those treated with TBI and those treated without TBI.

PROCEDURE: Data on the study cohort were collected from clinic charts, provider documentation in the electronic medical record of visits to survivorship clinic, including all subspecialists, and ancillary reports of laboratory and diagnostic tests done as part of risk-based screening at each visit.

RESULTS: All 48 survivors of BMT for high-risk neuroblastoma had numerous late effects of therapy, with 73% having between five and 10 late effects. TBI impacted some late effects significantly, including growth hormone deficiency (GHD), bone outcomes, and cataracts.

CONCLUSION: Although high-risk neuroblastoma survivors treated with TBI have significant late effects, those treated without TBI also continue to have significant morbidity related to high-dose chemotherapy and local radiation. A multidisciplinary care team assists in providing comprehensive care to those survivors who are at highest risk for significant late effects.

PMID:34971017 | DOI:10.1002/pbc.29537

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The new life of a teenager with a strange tumor on his face after the operation – Market Research Telecast

Saturday, January 1st, 2022

When he was just 10 years old, a giant facial tumor took over his face, completely disfigured it, and caused his mother will reject him and abandon him. Is about Kambou you, a young man from Ivory Coast, who is 18 today, and who had a very difficult life since childhood.

The aggressive mass began its journey on her cheek and then spread until her vision was difficult. I only had him support from his father, who accompanied him to undergo an operation abroad and obtained gratifying results, although he still has to undergo other surgeries to finish repairing the damage caused.

Read also: He is a painter, he lived anguished by the shape of his nose and a meeting at work brought him back his joy: God sent me an angel

In the beginning, Kambou, who likes to be called Prosper, was not treated and, as time went by, the tumor began to completely thicken his facial features. In addition to health problems, it also caused complications when interacting in the community: people used to ignore it or avoid it because no one knew anything about his condition and they thought it was contagious.

According to the definition of Macmillan, the British organization against cancer, this type of malformation is generated in the lymphatic system and develops when the body produces abnormal white blood cells.

It can have different manifestations, but the most extreme is the formation of tumors in areas such as the abdomen or face and it brings with it a lot of pain, bloating, nausea, and diarrhea. In the case of Kambou, it is added that the endemic species is found in Africa, so that your population is more exposed to contracting it.

Read also: Historic operation to build gender identity in Neuqun: they performed the first genital modification surgery

The serious illness led him from Bondoukou, his hometown in Ivory Coast, until Italy to start a treatment that would allow him to face the tumor and embark on a new course in his life.

Already installed in the European country, he visited the Hospital Pascale of Naples where they did various tests and found that it was a rare form of cancer that attacks the immune system called Burkitts lymphoma.

When I came here, I was often afraid. I think fear was the only thing I felt. My nose made it difficult for me to see and I had to cover it to be able to seeSaid Kambou, who underwent six months of chemotherapy, radiation therapy and stem cell replacement to shrink the tumor.

And he added: Three days after starting chemotherapy I realized that I no longer needed to cover my nose to see. Im very happy because when I go out I dont cry. Glad to meet people. I go out, I have fun, I play. I have no problems, I am very happy .

Once the cancer was removed, Prosper underwent three facial surgeries in which surgeons set about reconstructing her face. Having had a tumor of an extraordinary size, they had to repair the bone damage that the mass had caused.

According to what the specialist explained Doctor Fran Ionna, the results were amazing. However, there are still structures to improve on the young mans face: There is a defect in the development of the facial bones. There is an asymmetry. The right side of the face has an underdeveloped cheek bone and an eye socket that will have to be reconstructed , he explained.

In that sense, he assured that the young man will have to undergo several more surgeries because The cancer has affected the bone structure of his skull.

The young Ivorian stressed that, after treatment, he feels like a new man, Although he knows that there are still stages to achieve a definitive face and be able to return to his country. My face has changed. This is not over, but it has changed. I have also improved, I am not like before , he stressed.

Prosper is looking forward to returning to the Ivory Coast and starting a life from scratch. However, he valued have returned to school and have a girlfriend.

Disclaimer: This article is generated from the feed and not edited by our team.

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Best of what was new in diabetes health for 2021 – Dickson Post

Saturday, January 1st, 2022

Country

United States of AmericaUS Virgin IslandsUnited States Minor Outlying IslandsCanadaMexico, United Mexican StatesBahamas, Commonwealth of theCuba, Republic ofDominican RepublicHaiti, Republic ofJamaicaAfghanistanAlbania, People's Socialist Republic ofAlgeria, People's Democratic Republic ofAmerican SamoaAndorra, Principality ofAngola, Republic ofAnguillaAntarctica (the territory South of 60 deg S)Antigua and BarbudaArgentina, Argentine RepublicArmeniaArubaAustralia, Commonwealth ofAustria, Republic ofAzerbaijan, Republic ofBahrain, Kingdom ofBangladesh, People's Republic ofBarbadosBelarusBelgium, Kingdom ofBelizeBenin, People's Republic ofBermudaBhutan, Kingdom ofBolivia, Republic ofBosnia and HerzegovinaBotswana, Republic ofBouvet Island (Bouvetoya)Brazil, Federative Republic ofBritish Indian Ocean Territory (Chagos Archipelago)British Virgin IslandsBrunei DarussalamBulgaria, People's Republic ofBurkina FasoBurundi, Republic ofCambodia, Kingdom ofCameroon, United Republic ofCape Verde, Republic ofCayman IslandsCentral African RepublicChad, Republic ofChile, Republic ofChina, People's Republic ofChristmas IslandCocos (Keeling) IslandsColombia, Republic ofComoros, Union of theCongo, Democratic Republic ofCongo, People's Republic ofCook IslandsCosta Rica, Republic ofCote D'Ivoire, Ivory Coast, Republic of theCyprus, Republic ofCzech RepublicDenmark, Kingdom ofDjibouti, Republic ofDominica, Commonwealth ofEcuador, Republic ofEgypt, Arab Republic ofEl Salvador, Republic ofEquatorial Guinea, Republic ofEritreaEstoniaEthiopiaFaeroe IslandsFalkland Islands (Malvinas)Fiji, Republic of the Fiji IslandsFinland, Republic ofFrance, French RepublicFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabon, Gabonese RepublicGambia, Republic of theGeorgiaGermanyGhana, Republic ofGibraltarGreece, Hellenic RepublicGreenlandGrenadaGuadaloupeGuamGuatemala, Republic ofGuinea, RevolutionaryPeople's Rep'c ofGuinea-Bissau, Republic ofGuyana, Republic ofHeard and McDonald IslandsHoly See (Vatican City State)Honduras, Republic ofHong Kong, Special Administrative Region of ChinaHrvatska (Croatia)Hungary, Hungarian People's RepublicIceland, Republic ofIndia, Republic ofIndonesia, Republic ofIran, Islamic Republic ofIraq, Republic ofIrelandIsrael, State ofItaly, Italian RepublicJapanJordan, Hashemite Kingdom ofKazakhstan, Republic ofKenya, Republic ofKiribati, Republic ofKorea, Democratic People's Republic ofKorea, Republic ofKuwait, State ofKyrgyz RepublicLao People's Democratic RepublicLatviaLebanon, Lebanese RepublicLesotho, Kingdom ofLiberia, Republic ofLibyan Arab JamahiriyaLiechtenstein, Principality ofLithuaniaLuxembourg, Grand Duchy ofMacao, Special Administrative Region of ChinaMacedonia, the former Yugoslav Republic ofMadagascar, Republic ofMalawi, Republic ofMalaysiaMaldives, Republic ofMali, Republic ofMalta, Republic ofMarshall IslandsMartiniqueMauritania, Islamic Republic ofMauritiusMayotteMicronesia, Federated States ofMoldova, Republic ofMonaco, Principality ofMongolia, Mongolian People's RepublicMontserratMorocco, Kingdom ofMozambique, People's Republic ofMyanmarNamibiaNauru, Republic ofNepal, Kingdom ofNetherlands AntillesNetherlands, Kingdom of theNew CaledoniaNew ZealandNicaragua, Republic ofNiger, Republic of theNigeria, Federal Republic ofNiue, Republic ofNorfolk IslandNorthern Mariana IslandsNorway, Kingdom ofOman, Sultanate ofPakistan, Islamic Republic ofPalauPalestinian Territory, OccupiedPanama, Republic ofPapua New GuineaParaguay, Republic ofPeru, Republic ofPhilippines, Republic of thePitcairn IslandPoland, Polish People's RepublicPortugal, Portuguese RepublicPuerto RicoQatar, State ofReunionRomania, Socialist Republic ofRussian FederationRwanda, Rwandese RepublicSamoa, Independent State ofSan Marino, Republic ofSao Tome and Principe, Democratic Republic ofSaudi Arabia, Kingdom ofSenegal, Republic ofSerbia and MontenegroSeychelles, Republic ofSierra Leone, Republic ofSingapore, Republic ofSlovakia (Slovak Republic)SloveniaSolomon IslandsSomalia, Somali RepublicSouth Africa, Republic ofSouth Georgia and the South Sandwich IslandsSpain, Spanish StateSri Lanka, Democratic Socialist Republic ofSt. HelenaSt. Kitts and NevisSt. LuciaSt. Pierre and MiquelonSt. Vincent and the GrenadinesSudan, Democratic Republic of theSuriname, Republic ofSvalbard & Jan Mayen IslandsSwaziland, Kingdom ofSweden, Kingdom ofSwitzerland, Swiss ConfederationSyrian Arab RepublicTaiwan, Province of ChinaTajikistanTanzania, United Republic ofThailand, Kingdom ofTimor-Leste, Democratic Republic ofTogo, Togolese RepublicTokelau (Tokelau Islands)Tonga, Kingdom ofTrinidad and Tobago, Republic ofTunisia, Republic ofTurkey, Republic ofTurkmenistanTurks and Caicos IslandsTuvaluUganda, Republic ofUkraineUnited Arab EmiratesUnited Kingdom of Great Britain & N. IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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Hematopoietic Stem Cell Transplantation – StatPearls …

Wednesday, December 22nd, 2021

Continuing Education Activity

Bone marrow transplant, also known as hematopoietic stem cell transplant (HPSCT) involves the administration of healthy hematopoietic stem cells to patients with dysfunctional or depleted bone marrow. This helps to augment bone marrow function and, depending on the disease being treated, leads to either destruction of malignant tumor cells or to generation of functional cells that can replace the dysfunctional ones, as is the case of immune-deficiency syndromes, hemoglobinopathies, and other diseases. This activity reviews the indications, contraindications, and complications associated with hematopoietic stem cell transplants and highlights the role of the interprofessional team in the management of patients requiring this treatment.

Objectives:

Describe the indications for hematopoietic stem cell transplants.

Review the contraindications to hematopoietic stem cell transplants.

Outline the potential complications of hematopoietic stem cell transplants.

Describe the need for a well-integrated, interprofessional team approach to improve care for patients undergoing hematopoietic stem cell transplants.

Bone marrow transplant (hematopoietic stem cell transplant) (HPSCT) involves the administration of healthy hematopoietic stem cells in patients with dysfunctional or depleted bone marrow. This helps to augment bone marrow function and allows, depending on the disease being treated, to either destroy tumor cells with malignancy or to generate functional cells that can replace the dysfunctional ones in cases like immune deficiency syndromes, hemoglobinopathies, and other diseases.

History and Evolution

Hematopoietic stem cell transplantation (HSCT) was first explored in humans in the 1950s and was based on observational studies in mice models which showed that infusion of healthy bone marrow components into a myelosuppressed bone marrow could induce recovery of its function in the recipient.[1]These animal-based studies soon found their clinical application into humans when the first successful bone marrow transplant was performed in monozygotic twins in New York in 1957 (syngeneic transplant) in a patient with acute leukemia.[2]As a result, the physician Dr. Thomas who performed the procedure continued his research on the development of bone marrow transplantation and later received the Nobel Prize of physiology and medicine in appreciation of his work. The first successfulallogeneicbone marrow transplant was reported in Minnesota in 1968 for a pediatric patient with severe, combined immunodeficiency syndrome.[3]Since then, allogeneic and autologous stem cell transplant has increased in the United States and worldwide. The Center for International Blood and Marrow Transplant Research (CIBMTR) reported over 8000 allogenic transplants performed in the United States in 2016 with a higher number of autologous transplants with a steady and higher increase of autologous compared to allogenic.[4]

Definitions

Major Histocompatibility Complex (MHC)

The group of genes on the short arm of chromosome 6 (p6) that encodes human leukocyte antigens (HLA) which are considered being highly polymorphic leading to a large difference in the resultant expressed proteins on human cells. They are divided into MHC I and MHC II

Human Leukocyte Antigens (HLA)

These are the proteins expressed on the cellular surface and play an important role in alloimmunity. HLA can be divided into (HLA-A, B, and C) which are encoded by class I MHC and are expressed on all cell types and present peptides derived from the cytoplasm and are recognized by CD8+ T cells. The other HLA type is classified as (HLA- DP, DQ, and DR) which are encoded by MHC II and can be found on antigen-presenting cells (APCs) and this class is recognized by CD4+ T cells.

Syngeneic Bone Marrow Transplantation

The donor and the recipient are identical twins. The advantages include no graft versus host disease (GVHD) and no graft failure. However, only a tiny number of transplant patients will have the ability to have an identical twin for transplantation.

Autologous Bone Marrow Transplantation

The bone marrow products are collected from the patient and are reinfused after purification methods. The advantages include no GVHD. The disadvantage is that the bone marrow products may contain abnormal cells that can cause relapse in the case of malignancy hence; theoretically, this method cannot be used in all cases of abnormal bone marrow diseases.

Allogenic Transplantation

The donor is an HLA matched family member, unrelated matched donor or mismatched family donors (haploidentical).

Engraftment

The process of which infused transplanted hematopoietic stem cells produce mature progeny in the peripheral circulation

Preparative Regimen

This is a regimen that comprises high-dose chemotherapy and/or total body irradiation (TBI) which are administered to the recipient prior to stem cell infusion to eliminate the largest number of malignant cells and to allow for immunosuppression in the recipient so that engraftment can occur.

Malignant Disease

Multiple Myeloma

Autologous stem cell transplant accounts for most hematopoietic stem cell transplants according to CIBMTR in 2016 in the United States. Studies have shown increased overall survival and progression free survival in patients younger than 65 years old when consolidation therapy with melphalan is initiated followed by autologous stem cell transplantation and lenalidomide maintenance therapy.[5]The study showed a favorable outcome of high-dose melphalan plus stem-cell transplantation when compared with consolidation therapy with melphalan, prednisone, lenalidomide (MPR). It also showed a better outcome in patients who received a maintenance therapy with lenalidomide.

Hodgkin and Non-Hodgkin Lymphoma

Studies have shown that chemotherapy followed by autologous stem cell transplantation in cases of recurrent lymphomas (HL and NHL) that do not respond to initial conventional chemotherapy have better outcomes. A randomized controlled trial by Schmitz N et al. showed a better 3-year outcome of high-dose chemotherapy with autologous stem cell transplant compared to aggressive conventional chemotherapy in relapsed chemosensitive Hodgkin lymphoma. However, the overall survival was not significantlydifferent between the two groups.[6]The number of hematopoietic stem cell transplant recipient comes second after multiple myeloma according to CIBMTR.

Acute Myeloid Leukemia

Allogenic stem cell transplant has shown to improve outcome in patients with AML who fail primary induction therapy and do not achieve compete response and may prolong overall survival.[7]The study recommended that early HLA typing for patients with AML can help if they fail induction therapy and are considered for bone marrow transplant.

Acute Lymphocytic Leukemia

Allogenic stem cell transplant is indicated in refractory and resistant cases when induction therapy fails for a second time in inducing remission. Some studies suggest an increased benefit of allogenic hematopoietic stem cell transplant in patients with high risk ALL including patients with Philadelphia chromosome and those with t(4, 11).[8]

Myelodysplastic Syndrome

Allogenic stem cell transplant is considered being curative in cases of disease progression and is only indicated in intermediate- or high-risk patients with MDS.

Chronic Myeloid Leukemia/Chronic Lymphocytic Leukemia

Recipients with these two diseases come at the bottom of the list of patients who received allogeneic stem cell transplant in 2016. Hematopoietic stem cell transplantation has shown high cure rates but with availabletreatments like tyrosine kinase inhibitors and high success rates with low adverse risk profile, HSCTis reserved for patients with the refractory disease to first-line agents in CML.

Myelofibrosis, Essential Thrombocytosis, and Polycythemia Vera

Allogenic stem cell transplant has shown to improve outcomes in patients with myelofibrosis and those who had a diagnosis of myelofibrosis that was preceded by essential thrombocytosis and polycythemia vera.[9]

Solid Tumors

Autologous stem cell transplant is consideredthestandard of care in patients with germ cell tumor (testicular tumors) that are refractory to chemotherapy (after the third recurrence with chemotherapy).[10]HSCT has also been studied in medulloblastoma, metastatic breast cancer, and other solid tumors.

Non-Malignant Diseases

Aplastic Anemia

Systematic and retrospective studies have suggested an improved outcome with hematopoietic stem cell transplant in acquired aplastic anemia when compared with conventional immunosuppressive therapy.[11]Allogenic stem cell transplant has shown better outcomes when it was collected from bone marrow compared to peripheral blood in a study that involved 1886 patients with acquired aplastic anemia.[12]Patients with aplastic anemia need preparative regimen given they still can develop immune rejection to the graft.

Severe Combined Immune Deficiency Syndrome (SCID)

Large retrospective studies have shown increased overall survival in infants with SCID when they received the transplant early at birth before the onset of infections.[13]

Thalassemia

Allogenic stems transplant from a matched sibling donor is considered an option to treat Thalassemia and has shown 15-year survival reaching 80%. However, recent retrospective data showed similar overall survival compared with conventional treatment that consists of multiple transfusions in the case of thalassemia.[14]

Sickle Cell Anemia

Allogenic stem cell transplant is recommended for the treatment of sickle cell disease.[15]

Other Nonmalignant Diseases

Stem cell transplant has been used in the treatment of chronic granulomatous disease, leukocyte adhesion deficiency, Chediak-Higashi syndrome, Kostman syndrome, Fanconi anemia, Blackfan-Diamond anemia, and enzymatic disorders. Moreover, the role of stem cell transplant is being explored in autoimmune diseases including systemic sclerosis, systemic lupus erythematosus and has already shown promising results in cases like relapsing-remitting multiple sclerosis.[16]

There are no absolute contraindications for hematopoietic stem cell transplant.

Special equipment exists for the collection, preservation, and administration of stem cell products.

An interprofessional team approach is amainstay of ensuring the high-quality collection and infusion of stem cell products.

Preparation includes:

Mechanism of Action

The mechanism of action of stem cell transplant against malignancy in leukemia is based on the effect of the graft and donor immunity against malignant cells in recipients. These findings were demonstrated in a study that involved over 2000 patients with different leukemia. These patients received stem cell transplantation and showed that the lowest rate of relapses was in patients who received non-T-cell-depleted bone marrow cells and in those who developed GVHD compared to patients who received T-cell-depleted stem cells, those who did not develop GVHD, and patients who received syngeneic grafts. These findings support the notion that donor cellular immunity plays a central role in the engraftment's efficacy against tumor cells.[17]

The mechanism of action in autoimmune diseases is believed to be secondary to the increase in T-cell regulatory function which promotes immune tolerance. However, more studies are still needed to determine the exact pathophysiology.

In hemoglobinopathies, the transplanted stem cells produce functional cells after engraftment that replaces the diseased cells.

Administration

HLA Typing

HLA typing is an important step to determine the best donor suitable for stem cell collection. In theory, matched, related donors are the best candidates, followed by matched unrelated donors, cord blood, and then haploidentical donors. HLA typing is analyzed at either an intermediate-resolution level, which entails the detection of a small number of matched alleles between the donor serum and the recipient, or at a high-resolution level to determine the specific number of polymorphic alleles at a higher level. PCR and next-generation sequencing are used for HLA typing, and the results are reported as a score correlating with a match of two alleles for a specific HLA type. Different institutions use a different number of HLA subtypes for eligibility of donors but according to studies that showed matching for HLA-A, B, C, and DRB1 at a high-resolution level were associated with improved survival and outcomes.[18]Recommendations about donor HLA assessment and matching have been proposed by the Blood and Marrow Transplant Clinical Trials Network (BM CTN).[19]

The process may vary depending on the source of the stem cell site collection, whether it is bone marrow, peripheral blood, or cord blood. Moreover, there is a slight difference based on whether it is autologous, allogeneic, or syngeneic. For example, the procedure consists of initial mobilization of stem cells, in which peripheral blood stem cells are collected given the low number and the need for high levels of progeny cells, and then this is followed by preparative regimen and finally, infusion.

Mobilization and collection involved the use of medication to increase the number of stem cells in the peripheral blood given that there are not enough stem cells in the peripheral blood. The agents used include granulocyte colony-stimulating factors (G-CSF) or chemokine receptor 4 (CXCR4) blockers like plerixafor. G-CSF is believed to enhance neutrophils to release serine proteases which lead to a break of vascular adhesion molecules and the release of hematopoietic stem cells from the bone marrow. Plerixafor blocks the binding of stromal cell-derived factor-1-alpha (SDF-1) to (CXCR4) which leads to the mobilization of stem cells to the peripheral blood.[20]CD34+ is considered the marker for progenitor hematopoietic stem cells in the peripheral blood, and usually, a dose of 2 to 10 x 10/kg CD34+ cells/kg is needed for proper engraftment. Chemotherapy can be used in some instances for mobilization of hematopoietic stem cells; this process is termed chemoembolization.

The usual site of bone marrow collection is the anterior or posterior iliac crest. The procedure can be performed under local or general anesthesia. Complications include pain, fever, and serious iatrogenic complications can occur in less than 1% of cases. Multiple aspirations are done with each aspirate containing 15 mL. The goal is to collect up to 1 to 1.5 L of bone marrow product from the aspirations. The dose of nucleated cells from bone marrow should range between 2 to 4 x 10 cells/kg as studies showed that overall survival and long-term engraftment is strongly influenced by cell dose in allogeneic hematopoietic stem cell transplantation.[21]

The preparative regimen consists of administration of chemotherapy with or without total body irradiation for the eradication of malignant cells and induction of immune tolerance for the transfused cells to engraft properly. This process is not only limited to patients with malignancies but also extends to cases like aplastic anemia and hemoglobinopathies given that these patients have an intact immune system that could cause graft failure if there is no conditioning.

The preparative regimen is divided into myeloablative conditioning and reduced intensity conditioning. The preparative regimen depends on the disease being treated, existing comorbidities, and the source of the harvested hematopoietic stem cells. The preparative regimen consists of chemotherapy, total body irradiation, or both. There are different combination regimens used in the preparative period, and the choice of the regimen depends on the disease being treated, existing comorbidities, and previous exposure to radiation.

In the special case of SCID, there is no need for preparative regimen in patients receiving from HLA-matched siblings given that there are no abnormal cells that are needed to be eliminated and because immunosuppression caused by SCID can prevent graft rejection. Reduced-intensity conditioning is preferred in patients with prior radiotherapy, older age, the presence of comorbidities, and history extensive chemotherapy before BMT.[22]The advantages of using reduced-intensity conditioning include less need for transfusion due to the transient post-transplant pancytopenia and less damage to the liver in cases of chemotherapy and lung due to radiation.[23]However, the relapse rates are higher, but these regimens are more tolerated with a better safety profile in a specific patient population. Most of the chemotherapies used in preparative regimens consist of either potent immunosuppressive agents (high doses of cyclophosphamide 60 mg/kg IV), alkylating agents especially busulfan 130 mg/m2 IV, nucleoside analogs (fludrabine 40 mg/m2) and other agents like melphalan, antithymocyte globulin, rituximab, gemcitabine, and many others. Totalbodyirradiation (TBI) is performed using fractionated doses because it has shown less pulmonary toxicity when compared with one dose regimen.[24]The administration of the preparative regimen should immediately precede the bone marrow transplantation, and as a general rule, the effect of the regimen should produce bone marrow suppression within 1 to 3 weeks of administration.

Reinfusion of either fresh or cryopreserved stem cells can occur in an ambulatory setting and takes up to 2 hours. Before the infusion begins, quality measures are performed to ensure the number of CD34+ cells is sufficient.

Advantages and Disadvantages of Different Hematopoietic Stem Cells

The advantages of peripheral blood stem cells transplant (PBSCTs) include more rapid engraftment rate compared to bone marrow where it takes about 2 weeks of recovery in the former and is delayed for 5 days more in the latter,[25]but the use of post-transplant immunosuppressive regimen to prevent GVHD can prolong the increase in bone marrow products. Moreover, the rate of acute GVHD appears to be similar when compared with bone marrow transplantation in HLA- identical matched related donors.[25]However, chronic GVHD appears to be encountered more after peripheral blood stem cell transplant which could lead to more complications.[26]In the study by Anasetti et al., the primary endpoint was the difference in the 2-year overall survival seemed to be non-significant in the two groups. However, secondary end points showed more stable grafts with decreased graft failure in the group which received peripheral blood stem cell transplant but also this group had a higher incidence of chronic GVHD.[26]Other similar studies comparing both bone marrow transplant and peripheral blood SCTs concluded that the psychological burden due to chronic GVHD and the 5-year ability to restore normal activities including going back to work were better in the bone marrow transplanted group.[27]

The advantages of cord blood transplant include the rapid collection and administration which serves in treating urgent conditions, less frequency of infections, lower rates of GVHD with the same rate of GVT, less need for a stringent identical HLA. The disadvantages include delayed engraftment with a higher possibility of graft rejection and higher rates of disease relapses. The cord blood transplant is most used in patients without matched related or unrelated donors. A major study by Locatelli et al. demonstrated the utility of cord blood transplant in patients with thalassemia major and sickle cell anemia and showed similar 6-year overall survival in the CBT and BMT groups.[28]The most important factors that affect the outcome of CBT are the total nucleated cell dose and HLA matching with a recommended minimum dose of total nucleated cells of 2 x 10*7 cells/kg for successful engraftment. Theoretically, strict HLA matching is not required in the case of cord blood transplant given it is devoid of mature T cells but studies have shown better outcomes when matching recipients at HLA-A, HLA-B, HLA-C, and HLA-DRB1.[29]Given that a single blood cord unit might not contain the required amount of nucleated cells an approach using double cord transplant is used to overcome this problem. However, only one cord blood transplant product will predominate within 3 months of infusion. Further, randomized controlled trials failed to show a significant difference in terms of outcome benefits or risks between double cord blood and a single cord blood transplant.[30][31]

Haploidentical stem cell transplantation refers to the administration of bone marrow products from a first degree related haplotype-mismatched donor.[32]This helps in non-white patients like African American, Hispanics, and patients from countries where there is no wide access to resources as they have fewer chances of having a matched unrelated donor.[33]The advantages include lower cost and rapid availability of the hematopoietic cell products. However, the disadvantages include hyperacute GVHD which increases mortality and graft rejection.[34]This has been overcome by depletion of T cells responsible for the reaction mentioned above, but this also leads to delayed immune recovery and decreased graft versus tumor effect. Recently strategies including selective depletion of subsets of T cells including alpha-beta have shown improved outcomes when compared to conventional ex vivo depletion of large T-cell populations.[35]

Complications after bone marrow transplant can be divided into acute and chronic. Many factors can affect the occurrence of these adverse events including the age of the patient, baseline performance status, the source of stem cell transplant the type and intensity of the preparative regimen. Acute complications can occur in the first 90 days and include myelosuppression with neutropenia, anemia, thrombocytopenia, sinusoidal obstruction syndrome (SOS), mucositis, acute graft versus host disease, gram-positive/gram-negative infections, HSV, CMV, Candida, and Aspergillus. Chronic complications include chronic GVHD, infection with encapsulated bacteria and VZV. Levofloxacin is usually given by mouth or intravenously (IV) at day 1 post-transplant and is continued until absolute neutrophil count (ANC) is more than 1000 cells/uL or until the discontinuation of prednisonein cases of GVHD.[36]PCP prophylaxis is warranted given the immunosuppression following hematopoietic stem cell transplant.[37]Trimethoprim-sulfamethoxazole(TMP-SMX) is usually used, and several dosing regimens have been proposed. TMP-SMXis given 2 days per week until the patient is off immunosuppression.[38]Antifungal infection prophylaxis with fluconazole is recommended for 1 month following transplant as it has shown to decrease the incidence of fungal infections and no difference was seen when fluconazole was compared to voriconazole.[39][40]However, voriconazole is used in patients with a high-risk profile of developing severe forms of antifungal infection. Prevention against HSV and VZV is achieved with acyclovir that is continued for 1 month for the prevention against HSV and for 1 year for preventions against VZV.[41]Prophylaxis against CMV is only recommended in patients who test positive for CMV by PCR, and the treatment of choice is ganciclovir.

One unique syndrome encountered with cord stem cell transplant is cord colitis which involves diarrhea in recipients of cord blood and is believed to be secondary to Bradyrhizobium enterica[42]which usually responds to a course of metronidazole or levofloxacin.

Sinusoidal Obstruction Syndrome (SOS)

Also known as veno occlusive disease (VOD) is the result of chemotherapy during preparative regimen and occurs within 6 weeks of hematopoietic stem cell transplant. This syndrome consists of tender hepatomegaly, jaundice due to hyperbilirubinemia, ascites, and weight gain due to fluid retention. The incidence is reported to be 13.6% in an analysis study assessing the existing literature on the incidence of the disease.[43]The pathophysiology consists of endothelial damage to the hepatic sinusoids leading to obstruction and necrosis of the centrilobular liver.[44]The destruction of the sinusoids leads to hepatic failure and hepatorenal syndrome which areresponsible for the related mortality. The agents most commonly implicated in causing this syndrome are oral busulfan and cyclophosphamide. The use of IV busulfan has shown to decrease the occurrence of SOS.[45]The diagnosis is clinical and is based on hyperbilirubinemia greater than 2 mg/dL with the other clinical findings of tender hepatomegaly and fluid retention. Treatment consists of ursodeoxycholic acid (UDCA) which has shown to significantly decrease the occurrence of SOS when given pre and post-transplant.[46]Another medication, defibrotide, has shown efficacy in the treatment of SOS when it occurs.[47][48]

Idiopathic Pneumonia Syndrome (IPS)

This usually happens in the first 90 days post-transplant. The incidence is low and is related to direct chemotoxicity due to preparative regimen. Treatment with steroids is usually used although no randomized controlled clinical trials have been done to support their efficacy. Recently, etanercept has been studied in a randomized control trial in patients who develop this syndrome. The study assessed the addition of soluble TNF inhibitors to steroids in the treatment and has not shown added efficacy with combination therapy.[49]

Graft Rejection

The process of which there is a loss of bone marrow function after reconstitution following infusion of hematopoietic stem cells or if there is no gain of function after infusion and is termed graft failure or rejection. The incidence of failure is highest when there is a high HLA disparity that usually occurs in the case of cord blood and haploidentical donors and is lowest with autologous and matched donor siblings. Factors responsible for graft failure include but are not limited to functional residual host immune response to the donor cells, a low number of infused cells, in vitro damage during collection and cryopreservation, inadequate preparative regimen and infections.

Chimerism refers to the presence ofa cell population from a person in the blood of a different person. Checking for chimerism is an important step in ensuring engraftment and success of the transplantation. The physician does this by checking the expression of CD33 which indicates the presence ofgranulocytes and CD3 which indicate the presence ofT cells and confirming that most of the present cells are from the donor. The importance of effective chimerism has beendemonstrated in many studies that showed decreased relapse rates and increased survival in allogeneic transplantation.[50]

Graft Versus Host Disease

The graft versus host disease (GVHD) consists of the reaction between T-cells from the donor in allogeneic transplant and recipients HLA polymorphic epitopes that leads to a constellation of symptoms and manifestations. GVHD canbe categorized into acute and chronic which are both sub-categorized into classic and late onset, classic, and chronic overlap respectively.[51]Acute GVHD usually develops within three months. However, it can develop after 3 months and is termed delayed acute GVHD. Prophylaxis is usually achieved with calcineurin inhibitors, methotrexate, and anti-thymocyte globulins. Severity is estimated based on Glucksberg scale which classifies acute GVHD from grade I to VI, and treatment with either high dose prednisone or methylprednisolone isindicated in higher grades.[52]

Chronic GVHD occurs after three months and is represented by the involvement of multiple organs in a similar fashion to collagen vascular diseases. Grading has been developed by NIH (Global Grading System) to assess the severity of GVHD which determines the treatment modality and predicts survival [53]. Treatment is similar to that of acute GVHD, but the duration is usually over 2two years.[54]

Toxicity

Chemotherapy and radiation of preparative regimen along with post-transplant immunosuppression can induce severe pancytopenia in the first week following infusion of hematopoietic stem cells which can lead to life-threatening infection.This depends on the type and the dose of chemotherapy administered and factors related to the recipients. Chemotherapy causes a destruction of healthy,normal bone marrow products including neutrophils, macrophages, monocytes, and lymphocytes. Also, mucositis toxicity due to chemotherapy disrupts the barriers protecting against infectious agents, and use of indwelling intravenous catheters provides another mean of the entrance of infectious agents. Vaccination is recommended for the following agents according to the guidelines: pneumococcal conjugate (PCV), TDaP, Haemophilus influenzae, meningococcal conjugate, onactivated polio, recombinant hepatitis B, inactivated influenza, and MMR.[36]Several regimens of prophylaxis have been proposed to prevent infections depending on the risk stratification of patients (low-risk, high-risk, treatment of ongoing GVHD.

Many risk scoring tools exist for the evaluation of recipients of hematopoietic stem cell transplant and stratification of risks so that proper preparation and treatment can be established tominimize the risks and toxicities before, during, and after transplantation. Some of the most commonly utilized scores in clinical practice are the European Group for Blood and Marrow Transplantation (EBMT) risk score,[55]hematopoietic cell transplantation-comorbidity index/age,[56]and Armand disease risk index (DRI).[57]

Hematopoietic stem cell transplant use in clinical practice has been expanding in the last decade, and many clinical trials are still ongoing to assess its efficacyin different medical conditions.

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Autologous Stem Cell Transplant for Multiple Myeloma

Wednesday, December 22nd, 2021

The standard of care for fit multiple myeloma patients is to receive high-dose chemotherapy (HDT) with autologous stem cell rescue otherwise known as autologous stem cell transplant (ASCT) after completion of induction therapy. Autologous stem cell transplant can provide significant remission that is both long and deep, extending survival.

"Autologous" refers to the blood-making stem cells that are harvested from the patient to be a source of new blood cells after high-dose chemotherapy with melphalan. "Allogeneic" transplant, in which donor stem cells are used instead of the patient's own cells, is not performed in myeloma outside the context of a clinical trial.

High-dose therapy with stem cell rescue is a treatment option for many multiple myelomapatients, but several factors must be taken into consideration.

Age is the first factor to consider. Transplant is usually recommended for patients under age 65. Since high-dose chemotherapy is an intensive regimen, the patient must be medically fit enough to withstand it, with no major underlying medical issues. Some older patients are in excellent physical health and can be considered fit and transplant-eligible. Transplant eligibility is evaluated on an individual basis.

These risk-related factors include the type andthe stage of the disease, its aggressiveness and responsiveness to treatment, the levels of serum albumin and beta-2 microglobulin, and the presence or absence of certain chromosomal abnormalities in the patients myeloma cells. While there are similarities between patients, each patients disease has its own distinct characteristics. Therefore, general statements regarding patient outcomes both during the transplant procedure and post-transplant are inappropriate.

There is no conclusiveclinical data to suggest that transplantation earlier in the treatment regimen is better than waiting until later. Clinical trial results suggest that frontline therapy that includes an immunomodulatory drug and a proteasome inhibitor in combination may result in response rates and duration of response comparable to those of stem cell transplant, allowing some patients to postpone transplant until later in the course of the disease. This hypothesis is undergoing continued investigation.

Its important to remember that even if someone is a good transplant candidate, it is ultimately the patients decision whether or not to have a transplant. It is possible to have stem cells harvested and saved for a later treatment if the hospital has the storage capacity and the patient's insurance company will agree to pay for harvesting for later use leaving the patient open to other more immediate treatment options. Discuss these options with your physician and insurer.

Blood cell-making (hematopoietic) stem cells are located in the bone marrow*. Stem cell growth factors (also known as colony-stimulating factors) are injected to trigger the release of bone marrow stem cells into the bloodstream. These peripheral blood stem cells are then harvested and frozen for use within days, weeks, or years in the future. There are three main methods for stimulating the growth of blood cell-producing stem cells before they are harvested:

1. giving growth factors alone2. giving growth factors with chemotherapy3. using a stem cell mobilization agent with growth factors.

*You may also hear stem cell transplant referred to as hematopoietic stem cell transplant.

The medical term for removal of hematopoietic stem cells from the circulating blood (harvesting stem cells) is apheresis, a procedure whereby blood from the patient passes through a machine that separates and then removes stem cells. The rest of the blood is immediately returned to the patient. The procedure lasts 3 to 4 hours each day for 1 to 5 days, and is usually done on an outpatient basis.

Side effects of apheresis are temporary and are caused by changes in the volume of the patients blood as it circulates in and out of the apheresis machine, as well as by the blood thinners added to keep the blood from clotting during the procedure. The most common side effects experienced during apheresis are slight dizziness and tingling sensations in the hands and feet. Less common side effects include chills, tremors, and muscle cramps.

After collection, the peripheral blood is taken to the processing laboratory for freezing (cryopreservation). The stem cells are mixed with a solution containing dimethyl sulfoxide (DMSO), then frozen and stored in liquid nitrogen. The stem cells can be stored frozen for as long as necessary until the time they are transplanted. Excellent function of stems cells is retained for at least 10 years.

A number of studies have been completed to determine the number of stem cells you need to safely undergo high-dose therapy. The number is quantified by a laboratory technique called CD34+ cell analysis by flow cytometry. A minimum number of stem cells to safely complete a transplant is 2 million CD34+ cells per kilogram of body weight. The stem cell collection process continues daily until the planned number of stem cells is collected. Most transplant physicians collect enough stem cells for two transplants (at least 4 million CD34+ cells per kilogram of body weight).

After the harvested stem cells are frozen, the patient is ready to receive high-dose chemotherapy to destroy the myeloma cells. High-dose chemotherapy kills these cells inside the patients body more effectively than standard-dose chemotherapy.

Since high-dose treatment destroys the normal bone marrow in addition to the myeloma cells, the collected stem cells are unfrozen andgiven back into the bloodstream through an intravenous (into a vein) catheter one to two days after administration of the high-dose chemotherapy. This infusion is often referred to as the transplant. It is not a surgical procedure and usually takes place in the patients room over the course of 1 to 4 hours. Infused stem cells travel through the bloodstream to the bone marrow, where they begin to produce new blood cells, a process called engraftment. It takes 10 to 14 days for the newly produced blood cells to enter the bloodstream in substantial numbers, and the patient may be given growth factors to speed up this process. The average time for the chemotherapy, transplant, and recovery is approximately 3 weeks. Not all transplant centers require that patients remain in the hospital after the infusion of stem cells.

In addition to obliterating the bone marrow, high-dose chemotherapy can cause other severe side effects, which may require a stay in the hospital fortreatment during this period. Some of the more common side effects include nausea, vomiting, diarrhea, mouth sores, skin rashes, hair loss, fever or chills, and infection. Medications are given to prevent or lessen some of the expected side effects, and patients are closely monitored during and after the administration of high-dose chemotherapy.

Until engraftment of the stem cells takes place, the bodys immune system is weakened by the effects of the high-dose chemotherapy, and patients are very susceptible to developing infections. Even a minor infection like the common cold can lead to serious problems. Therefore, special precautions are necessary during recovery. Patients may remain in the hospital until the white blood cell counts reach a level safe enough for the patient to be discharged. The following supportive care measures may be required:

Patients and their caregivers are given instructions for maintaining a safe environment at home to help prevent infection while the immune system continues to recover.

After the stem cells have been infused, many transplant centers use white blood cell growth factors (e.g., Neupogen, Neulasta, Leukine) to help stimulate the bone marrow to produce normal blood cells. These injections continue until the white blood cell count returns to normal. During this time, a blood transfusion(s)may be necessary. Once symptoms resolve and the risk of serious infections is reduced, transfusions will no longer be needed. Although patients may be well enough to leave the hospital, the recovery process will continue at home for 1 to 4 months, and patients usually cannot resume normal activities for up to 3 to 6 months, although this varies from individual to individual. Having a support network is very important during this time. Waiting for the transplanted stem cells to engraft, for blood counts to return to safe levels, and for side effects to disappear is often the most difficult time for both patients and their loved ones. It is important to take things one day at a time: one day a patient may feel much better, but the next day feel too weak to do much more than sleep.

High-dose chemotherapy with stem cell rescue can place physical, psychological, emotional, and financial stresses on patients and their families. Patients may experience feelings of anger, depression, and anxiety over an unknown future and a lack of control. We urge you to take advantage of support services offered through the hospital and other organizations, including myeloma support groups, or to seek a referral from your oncologist for psychological counseling or psychiatric consultation.

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Autologous Stem Cell Transplant for Multiple Myeloma

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City of Hope presents leading-edge research on blood cancer therapies and its vaccine to reduce stem cell transplant complications at American Society…

Wednesday, December 22nd, 2021

DUARTE, Calif.--(BUSINESS WIRE)--City of Hope doctors presented data on an investigational bispecific antibody for multiple myeloma and the CMVPepVax, a City of Hope-developed vaccine against the cytomegalovirus, at this years ASH Annual Meeting.

City of Hope continues to be a leader in innovative research on investigational immunotherapies for blood cancers and improving stem cell transplants, said Eileen Smith, M.D., City of Hopes Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation. New research at this years ASH conference includes promising investigational immunotherapies for lymphoma, multiple myeloma, leukemia and other blood cancers and an update on a City of Hope-developed vaccine to prevent a virus that can cause serious complications in stem cell transplant recipients.

Here are highlights of City of Hope research presented at the ASH conference:

Investigational bispecific antibody for multiple myeloma is well-tolerated and effective

Bispecific antibodies are an emerging immunotherapy against blood cancers. City of Hopes Elizabeth Budde, M.D., Ph.D., presented at this years ASH conference on mosunetuzumab. The research demonstrated that mosunetuzumab is a safe and effective investigational bispecific antibody for follicular lymphoma.

Talquetamab is an investigational therapy that is also demonstrating encouraging results for the treatment of relapsed multiple myeloma, according to a study led by Amrita Krishnan, M.D., director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at City of Hope and chief, Division of Multiple Myeloma.

Talquetamab targets the G protein-coupled receptor family C group 5 member (GPRC5D) that has a high expression on malignant plasma cells and is limited on normal human tissue. The first-in-class bispecific antibody directs T cells to kill multiple myeloma cells by binding to both GPRC5D and CD3 receptors.

Patients with relapsed or difficult to treat multiple myeloma in the Phase 1 study received recommended Phase 2 doses as an injection on a weekly or biweekly basis. By increasing the doses slowly, researchers hope that will help to minimize the severity of cytokine release syndrome.

Krishnan presented data on 55 patients. For the study, 30 patients who received the therapy weekly (and their results were evaluable, meaning they could be included in the study) and 23 people who received it on a biweekly schedule were included. The study is ongoing.

In the weekly cohort, the overall response rate was 70% and there was a very good partial response or better in 57% of patients.

The response numbers are very strong and whats also remarkable is that the responses were durable and deepened over time in both groups, Krishnan said.

Cytokine release syndrome occurred in 73% of the weekly dose cohort, but only one patient had a severe case and it was treatable. Other side effects included neutropenia and dysgeusia.

We are excited that our results demonstrated that talquetamab is well-tolerated and highly effective at the Phase 2 dose level and with tolerable side effects, Krishnan said.

Further studies of the therapy on its own or in combination with other treatments for multiple myeloma are underway.

City of Hope-developed vaccine to prevent cytomegalovirus shows safety, tolerability

Despite therapies to help prevent the cytomegalovirus (CMV), which can flare up in blood marrow/stem cell transplant recipients who are immunocompromised, CMV infections are one of the most common complications in these patients. Furthermore, the antiviral drugs used to prevent flare-ups are toxic, expensive and increase the risk of other opportunistic infections.

City of Hope has developed an anti-CMV vaccine, known as CMVPepVax. At this years ASH conference, the results of a Phase 2 trial using CMVPepVax were reported by Ryotaro Nakamura, M.D., City of Hopes Jan & Mace Siegel Professor in Hematology & Hematopoietic Cell Transplantation in the Division of Leukemia.

The double blinded, placebo-controlled, randomized Phase 2 trial enrolled stem cell transplant recipients from four transplant centers, including City of Hope. Nakamura reported on data from 32 patients in the vaccine arm and 29 patients in the placebo arm.

CMVPepVax was delivered via injections 28 days after transplant and 56 days after the procedure.

Trial results demonstrated that there was no difference in CMV reactivation in both arms.

CMVPepVax was well-tolerated in patients with no increase in adverse side effects. Transplant outcomes were also similar between the two groups when comparing one-year overall survival, relapse-free survival, nonrelapse mortality, relapse and acute graft-versus-host disease (GVHD).

Significantly higher levels of CMV-targeting T cells were measured in patients in the vaccine arm who did not have CMV in their bloodstream. In patients who had the CMVPepVax injections, robust expansion of functional T cells also occurred.

Our results confirm that CMVPepVax is safe to use and provides an immune response, Nakamura said. Although the vaccine did not reduce the presence of CMV in the bloodstream, there were favorable CD8 T cell responses, which are protective in principle, but maybe didn't recover fast enough to prevent CMV from reactivating.

Next steps include researching whether stem cell donors who receive the vaccine can transfer immunity to patients, as well as providing a booster to patients. This may lead to faster immune responses after transplant.

Using probiotics for stem cell transplant patients

City of Hope is a leader in bone marrow and stem cell transplantation it was one of the first cancer centers nationwide to perform a bone marrow transplant and has performed more than 17,000 bone marrow/stem cell transplants since 1976. Because of this leadership, City of Hope doctors and scientists are investigating how to make the transplant process better, as well as how to deal with complications that may arise from the procedure, such as GVHD.

Led by Karamjeet S. Sandhu, M.D., an assistant professor in City of Hope's Division of Leukemia in the Department of Hematology & Hematopoietic Cell Transplantation, a City of Hope study examined how adding the probiotic CBM 588 to transplant recipients diets might decrease inflammation in the gut and lower the risk of GVHD. The results were discussed in an oral presentation at the ASH conference.

Sandhu explained that the body hosts microbial communities, known as the microbiome. These microbes help the body in several metabolic processes, such as digesting food, strengthening the immune system, protecting against other bacteria and producing vitamins, including B vitamins.

Recent studies have shown the microbiome can play a role in cancer risk and how a persons body responds to cancer treatment. In people with blood cancers who receive a transplant, there is a direct link between the health of microbiome and survival.

Imbalance among these microbial species have also been associated with several transplant complications including GVHD, said Sandhu, M.D. He added that the imbalance also contributes to morbidity and mortality.

For the study, Sandhu and his team used Clostridium Butyricum Miyairi 588 (CBM588), a probiotic strain that has been used in Japan for several decades to manage diarrhea caused by antibiotics or infections. CBM588 is a butyrate-producing bacteria present in the spore form in soil and food. Administration of CBM588 has shown anti-inflammatory and immune modulating effects, as well as evidence of anti-cancer activity.

This was the first study of CBM588 among bone marrow/stem cell transplant recipients. Fifteen patients received the current standard of care therapies to prevent GVHD and 21 received CBM588 in addition to standard of care for GVHD.

Our study demonstrated that CMB588 is safe and feasible to use in this patient population without increasing mortality, Sandhu said. We even noted an improvement in gastrointestinal GVHD, but further studies are needed to prove the effect and mechanism of action among recipients of bone marrow/stem cell transplantation.

Joint study examines somatic mutations in CMML patients, impact on stem cell transplants

Chronic myelomonocytic leukemia (CMML) is a rare form of leukemia that primarily affects older adults. The only potential cure at this time is allogeneic hematopoietic cell transplantation, also known as a stem cell transplant.

Research has shown that somatic mutations genetic changes that are acquired during life and not inherited are an important factor in determining prognosis for CMML patients. However, limited data are available regarding their impact on outcomes after CMML patients receive transplant.

A joint study between City of Hope and Center for International Blood and Marrow Transplant Research (CIBMTR) analyzed the relationship between somatic mutations in CMML and their impact on stem cell transplants.

Additionally, the study aimed to evaluate two separate scoring systems commonly used in nontransplant CMML patients, the CMML-specific prognostic scoring system (CPSS) and molecular CPSS (CPSS-Mol), which takes into account the somatic mutations, to find out if they can predict the results of a transplant.

Led by City of Hopes Matthew Mei, M.D., an associate professor in City of Hopes Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, the study included 313 patients across 78 different transplant centers, all of whom underwent a comprehensive mutation analysis of 131 genes performed at City of Hope under the supervision of Raju K. Pillai, M.D., director of Pathology Core Laboratories in Beckman Research Institute of City of Hope.

The study found that 93% of patients had at least one mutation identified, and the median number of mutations was three. The most frequently mutated genes were ASXL1 (62%), TET2 (35%), KRAS/NRAS (33% combined) and SRSF2 (31%); TP53 was mutated in 3% of patients.

Both the CPSS and CPSS-Mol were predictive of overall survival after transplant; however, neither system was able to identify patients who were at an increased risk of relapse. Furthermore, the incorporation of somatic mutations did not appear to refine the prognosis.

Our study is the largest analysis of CMML patients who underwent a stem cell transplant with paired mutation analysis, Mei said. Overall, patients with CMML remain at high risk for relapse after transplant. Novel therapies aimed at decreasing relapse and making transplants safer, as well as improved methods of predicting outcomes of transplant in CMML, are still critically needed.

Additional research on chimeric antigen receptor (CAR) T therapy and stem cell transplantation presented at ASH

Tanya Siddiqi, M.D., director of City of Hope's Chronic Lymphocytic Leukemia Program, also presented a poster on the Transcend NHL 001 trial at the ASH conference, and Ibrahim Aldoss, M.D., associate professor, City of Hope's Division of Leukemia, presented a poster on the outcomes of allogeneic hematopoietic cell transplantation in adults with Ph-like acute lymphoblastic leukemia.

City of Hope is a leader in blood cancer research and treatment. The National Cancer Institute-designated comprehensive cancer center has performed more than 17,000 bone marrow/stem cell transplants and is a leader in chimeric antigen receptor (CAR) T therapy, with nearly 800 patients treated with immune effector cells, including CAR T therapy, and nearly 80 open or completed trials.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope, a subsidiary launched in 2019, serves employers and their health care partners by providing access to NCI-designated cancer center expertise. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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City of Hope presents leading-edge research on blood cancer therapies and its vaccine to reduce stem cell transplant complications at American Society...

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Adaptation Is Key to Advancing Care for Adult Patients With Leukemia – OncLive

Wednesday, December 22nd, 2021

Jorge E. Cortes, MD, has been an investigative leader for nearly 30 years in the development of numerous leukemia treatments.

It would be difficult to look at data involving practice-changing agents for patients with leukemia and miss the name Jorge E. Cortes, MD. An investigative leader for nearly 30 years, Cortes has led the development of numerous leukemia treatments, including trials for the second-generation tyrosine kinase inhibitor (TKI) bosutinib (Bosulif), which is widely used for chronic myeloid leukemia (CML); omacetaxine mepesuccinate (Synribo), a drug approved for patients with CML when TKIs have stopped working; the third-generation TKI ponatinib (Iclusig), another CML treatment; and glasdegib (Daurismo), a smoothened inhibitor approved for the treatment of older patients with acute myeloid leukemia (AML) and complications like heart or kidney disease that preclude use of intensive induction chemotherapy.

Today, Cortes is leading something even larger than drug trials: the Georgia Cancer Center at Augusta University, which named him its director in 2019, following a 20-plus year career at The University of Texas MD Anderson Cancer Center in Houston. Working to make Georgia Cancer Center a world-class facility and continuing with as much research as possible keeps Cortes busy, but he has still found time to cochair the 26th Annual International Congress on Hematologic Malignancies hosted by Physicians Education Resource (PER), LLC.

The hybrid interactive conference will be held from Thursday, February 24, 2022, to Sunday, February 27, 2022, at the Eden Roc in Miami Beach, Florida. The 4-day event will focus on leukemias, lymphoma, and myeloma. Its presentations and panels will cover the latest developments in chimeric antigen receptor (CAR) T-cell therapy, the most pivotal new trial results, the use of genomics and molecular testing in hematological cancers, and how to cope with the emerging value basedcare landscape.

At MD Andersonwhere he rose from a fellow to the deputy chair of the Department of Leukemia Cortes established himself as one the worlds leading leukemia researchers and the coauthor of more than 1000 published papers. At Georgia Cancer Center, he has less time for research, but he has still managed to launch another multicenter trial of an experimental CML treatment.

[Cortes] is truly a world expert on all things leukemia, has peerless clinical experience, and is an undisputed leader in the field. He has been instrumental in a very large number of trials that have led to drug approvals, and he ranks among the most published authors in the scientific world, Alexander E. Perl, MD, MS, said. Perl is an associate professor of medicine at Perelman School of Medicine at the University of Pennsylvania and a member of the leukemia program in the Abramson Cancer Center in Philadelphia, who has worked with Cortes on trials of FLT3 inhibitors.

Hes an excellent speaker as well, Perl added, and will make a great chair for the conference.

Courtney D. DiNardo, MD, MSCE, a clinical researcher in the Department of Leukemia at MD Anderson Cancer Center, said the key to Cortes success is a level of drive that is unusual even in a world of highly driven people.

Hes always moving; hes always thinking. Hes kind of like the Energizer Bunny. He just keeps going and going, she said.

The agenda for the International Congress on Hematologic Malignancies features dozens of presentations and panels, and most of them are followed directly by question-and-answer sessions with thought leaders. The other program cochairs are Andre H. Goy, MD, physician in chief at Hackensack Meridian Health Oncology Care Transformation Service, chairman and chief physician officer at John Theurer Cancer Center, Lydia Pfund Chair for Lymphoma, Academic Chairman Oncology at Hackensack Meridian School of Medicine, and professor of medicine at Georgetown University in Hackensack, New Jersey, and Sagar Lonial, MD, FACP, chief officer of Winship Cancer Institute of Emory University in Atlanta, Georgia.

The key topics for discussion will include the following:

A MODERN LANDSCAPE

Cortes recently sat down for an in-depth interview with OncologyLive to preview the conference and share his thoughts about the major trends in leukemia treatment.

When I started, leukemia treatment was easy, Cortes said. [Individuals] with AML got 7 plus 3 [cytarabine continuously for 7 days and an anthracycline on each of the f irst 3 days of a treatment cycle]. Patients with CML would get interferon. And individuals with a model of proliferative neoplasms got hydroxyurea. And that was it. It was very easy. Unfortunately, the results were terrible.

Nowadays, theres a lot more complexity in our understanding of the biology. Theres not one AML, theres not one ALL [acute lymphoblastic leukemia]. There are a lot more challenges in classifying the cancer, and the same is true in treatment. We have a lot more treatment options, but the increase in treatment options means that its a lot harder to pick the right one. How do I select when I have 3 or 4 options? How do I combine them? What is the relative value? The answers to all these questions are evolving very rapidly because there [are] a lot of data coming out.

Among the biggest topics of conversation at the hematology conference will be recent trial results for CAR T-cell therapy. In October, the FDA approved brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory B-cell precursor ALL. The approval was based on results from the ZUMA-3 trial (NCT02614066), in which 71 patients were enrolled and underwent leukapheresis. The CAR T-cell therapy was then successfully manufactured for 65 of those patients and administered to 55. At the median follow-up of 16.4 months, 31 (56%) patients reached complete remission (CR). The median duration of remission was 12.8 months (95% CI, 8.7 months-not estimable [NE]). Median relapse-free survival was 11.6 months (95% CI, 2.7-15.5), and median overall survival (OS) was 18.2 months (95% CI, 15.9 months-NE). Among responders, median OS was not reached at the time of analysis.1

A few days before that approval, Kite submitted a supplemental biologics license application to the FDA to expand the current indication of the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) to include the second-line treatment of adult patients with relapsed or refractory large B-cell lymphoma. The application was based on findings from the phase 3 ZUMA-7 trial (NCT03391466), which showed improved event-free survival compared with standard of care after a median follow-up of 2 years. Among the 359 patients who were randomized 1:1 to CAR T-cell therapy or standard of care, patients in the experimental group experienced a 60% reduction in events.2

We will present a lot of data on CAR T-cell therapy, Cortes said. This is a rapidly emerging field, with a large number of new trial results, not just in acute lymphoblastic leukemia but, increasingly, in other areas as well, and we dedicate a whole section of the conference to the understanding of CAR T-cells. This is something that was addressed last year, but we will do it again because new information keeps coming, and now theres the new indication in acute lymphoblastic leukemia.

Cortes said that studies with venetoclax (Venclexta) in AML will also be discussed. We will present [findings] from the initial phase 1 and phase 2 trials and then the randomized phase 3 studies that cemented venetoclax as the standard of care in a short period of time.

Results of the phase 3 Viale-A (NCT02993523) trial led to venetoclax being adopted as the standard treatment in older patients with previously untreated AML. The trial randomized 286 patients to receive azacitidine plus venetoclax and 145 patients to receive azacitidine plus placebo. At a median follow-up of 20.5 months, the median OS was 14.7 months in the azacitidine/venetoclax group vs 9.6 months in the control group (HR for death, 0.66; 95% CI, 0.52-0.85; P < .001). Participants were also more likely to experience CR (36.7% vs. 17.9%; P < .001) and composite CR (66.4% vs 28.3%; P < .001). Serious adverse events occurred in 83% of patients in the experimental arm vs 73% of patients in the control arm.3 These data, as well as data from the phase 3 VIALE-C trial (NCT03069352), supported the FDA decision in October 2020 to grant regular approval to venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of adults 75 years and older with newly diagnosed AML.4,5

Another major focus of conversation will be research indicating that many patients with CML who have responded completely to TKI treatment and gone several years with no evidence of disease can safely discontinue treatment.

We have [an] increasing amount of trial data on this issue, Cortes said. We want to present the data from The LAST Study [NCT02269267] and elsewhere and put those trials in context and explore which patients are good candidates for treatment discontinuation and how we can do it right to minimize the risk for patients.

EXPANDING HORIZONS

Cortes credits his career in medicine to his uncle. When I was in high school, I wanted to be a dentist for some reason, but my uncle, whom I was very close with, asked me why I wanted to limit myself to treating the mouth when I was a good enough student to become a doctor and treat the whole body. Eventually he convinced me that medicine was probably a better path for me, he said.

The decision to specialize in leukemia treatment and research also happened more by chance than by design. Cortes attended medical school and did his residency in his native Mexico before arriving in Houston for a hematology fellowship at The University of Texas Health Science Center. A portion of his rotation was held across the street at MD Anderson Cancer Center, where he met the team working on leukemia. Impressed by the investigators in the laboratory and the work they were doing, Cortes switched his program to focus on leukemia. More than 1000 papers later, his focus remains unchanged.

Remember, were talking about almost 30 years ago, so in those days, [treating leukemia] was very, very challenging, Cortes said. There were very few new therapies available in leukemia, but there was a good opportunity to study because access to tissue is readily available. You also got the outcomes very quickly, so the clinical trials could be conducted rapidly.

Location was also important to fueling his research. [Houston] was a very active environment for research, Cortes said. There were lots of clinical trials, lots of academic discussions and interaction, so I thought it was a field that was very ripe for discoveries, and sure enough, a lot of new things have happened since then. Some of them, Ive been a part of, and some of them, Ive been a witness to, but its been a very rapid development.

Cortes interest in and experience with TKIs dates all the way back to the beginning. He was investigating CML with Moshe Talpaz, MD; Hagop M. Kantarjian, MD, a 2014 Giants of Cancer Care award winner in the leukemia category; and others at MD Anderson when the initial phase 1 trials of imatinib (Gleevec) began. He saw the incredible efficacy of the drug in those first patients and realized the great potential of targeted medications, specifically with TKIs.

The potential has been recognized in recent years in the expansion of targeted agents and a growing number of assays. Strategies for selecting the best therapies will be a major topic of conversation at the International Congress on Hematologic Malignancies.

We will have an outstanding presentation on the increasing complexity and the molecular diversity of acute lymphoblastic leukemia, which is a rapidly evolving area. Its become very complex, but also very specific, so this presentation will discuss how to use that information to manage patients, Cortes said. We will have the same sort of presentation for acute myeloid leukemia because again, its become a necessity to assess your patient to understand how to proceed with treatment.

There will also be information on these molecular abnormalities in individuals that do not have leukemia but do [have] predisposing factors, these CHIPsor clonal hematopoiesis of indeterminate potential. We have analyses of what these clonal entities mean, and we need to continue discussing them as we try to understand how they should affect our approach.

SHAPING THE NEXT GENERATION

You could say that Cortes enjoys being in the weeds of drug development, having a hand in the process from start to finish. He enjoys the complexity of running large drug trials, analyzing early-stage data to construct late-stage protocols, assembling research teams, and working with both drug companies and the FDA.

Drug development is a very complex endeavor, he said. Having a drug that works is obviously very important, but you have to design the trials in such a way that you get not only the academic answers and the clinical answers that you want, but also the data you need for regulatory approval. You also need to work with a lot of different groups investigators, sponsors, regulatory authorities, and most importantly, you have to work with patients. You need to recruit and enroll them.

Cortes noted that one of the key challenges is adapting opinions about drugs as new information becomes available and modifying trial design accordingly.

Even when the drugs look good initially, you also have to acknowledge that you know very little, and sometimes you learn things that that you didnt expect, he said, citing his experience with the agent ponatinib. It looked like a wonderful, very effective drug, but we learned that ponatinib had risk of arterial occlusive eventsheart attacks, strokes, and things like thatwhich was completely unexpected. The [challenge] was how to react to that. How do you balance the risk-benef it ratio? How do you [work] with the sponsor, the regulator agencies, and the patients?

Cortes strategy for managing these adverse effects secured ponatinib its 2012 FDA approvalalbeit with a black box warningfor the treatment of adults with CML and Philadelphia chromosomepositive ALL. Last year, the FDA expanded the indication. Both approvals were supported by data from the phase 2 PACE trial (NCT01207440)6; the second indication was also supported by data from the phase 2 OPTIC trial (NCT02467270).7

When we talk about what it takes to run a good trial, it all sounds straightforward, almost to the point of being obvious, but its not, DiNardo said. Doing good clinical research is a challenge, and some people are much better at it than others. I worked with Dr Cortes on several trials when I was new to the leukemia team at MD Anderson, and I am very happy I got a chance to learn from the best.

LOOKING BEYOND THE CURVE

Among the discussion of new trial results and new diagnostic tests, the International Congress on Hematologic Malignancies will also explore a relatively new concern: weighing the relative value of various potential treatments beyond their statistical significance.

Youre looking to maximize value for the patient, Cortes said. In a randomized trial, you [are looking to] get an improvement in survival that has a statistical value. But statistical significance may or may not mean something clinically. If [the survival benefit] is just a few weeks and the toxicity profile is harsh, how much of that extra time is spent in the hospital or suffering because of adverse effects? The survival benefit can be somewhat diluted by what kind of lifestyle you have. Youre alive, but are you living a normal life or at least close-to-normal life? And then, you know, how much are you paying for each week or month of extended survival? These are all things you need to consider, and were seeing more interest in thinking about how to balance them.

Cortes has taken a particular interest in improving quality of life for older patients and those with comorbidity that made traditional treatments hard to tolerate. Age alone doesnt make you less able to tolerate treatment, but it is more common that older patients will not be able to tolerate treatment, he said.

Cortes interest in investigating treatments for older patients helped inspire his work to develop glasdegib. The agent was approved in November 2018 in combination with low-dose cytarabine for patients with newly diagnosed AML who are 75 years or older with comorbidities that preclude intensive induction chemotherapy.8 That approval was supported by data from the BRIGHT AML 1003 trial (NCT01546038), in which 115 patients were randomized to receive low-dose cytarabine with or without glasdegib. After a median follow-up of 20 months, median OS was 8.3 months (95% CI, 4.4-12.2) in the investigative arm vs 4.3 months (95% CI, 1.9-5.7) in the control arm (HR, 0.46; 95% CI, 0.300.71; P = .0002).

[Older patients] have more comorbidities; they frequently take other medications, so you have to consider drug-drug interactions, Cortes said. There is also a tendency to give uppatients give up on themselves, doctors are more likely to give up on [finding treatments]and you need to avoid that. Life expectancy is much longer now than it was 30 years ago. For trial [design] purposes, we used to consider patients over 55 [years] as elderly. We wouldnt even [enroll them to] stem cell trials. Nowadays that sounds ridiculous. We realize that its just as important to combat cancer in these patients as it is in patients of any other age.

CARVING OUT A CORNER OF CARE

To relax and recharge, Cortes naturally enjoys something that keeps him moving full speed ahead: long-distance running. I love to run. I have done 8 marathons so far. Ive run them in Chicago, Boston, New York, and Houston. Ill be doing Houston again [in 2022], and hopefully that will qualify me to return to Boston, said Cortes, whose best marathon time is 3 hours and 30 minutes.

Why running? Part of the allure is the chance to get away from stuffy indoor spaces and spend long periods outside. He even enjoys bad-weather days because he likes making himself endure conditions that would send others to the treadmill.

The challenge is the point of long-distance running. Its demanding. The race is demanding. The training is demanding. But it gives you a feeling of accomplishment, he said. I also like that its an individual sport. If I have a bad day, Im not hurting any teammates. Running lets you run your race, at your own pace. You set your goals, and its fun to meet them. But if you dont, you just try again.

References

See the original post:
Adaptation Is Key to Advancing Care for Adult Patients With Leukemia - OncLive

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