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Study concludes improving access to care could close much of racial gap

Differences in insurance account for a substantial proportion of the excess risk of death from breast cancer faced by black women, according to a new study appearing in the Journal of Clinical Oncology. It concludes that equalizing access to care could address much of the existing black/white disparity in breast cancer mortality.

Breast cancer mortality was higher in white women than in black women until the 1980s, when improvements in early detection and treatment began to create a gap between black and white women. Whites benefitted more from these improvements, and since then, the black-white mortality gap has continued to widen. In 2014, the most recent year for which data is available, breast cancer mortality rates were 41% higher in black women than white women.

For the new study, investigators from the American Cancer Society, Emory University, and Dana-Farber Cancer Institute examined the contributions of demographics, other medical conditions (comorbidities), insurance, tumor characteristics, and treatment to black-white mortality disparities among more than 550,000 nonelderly women diagnosed with early stage breast cancer. The data come from the National Cancer Database, a national hospital-based cancer registry cosponsored by the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society.

Compared with white women, black women were more likely to be uninsured or have Medicaid insurance (22.7% v 8.4%) and were more likely to have tumors that were larger, higher grade, and hormone receptor negative. Hormone receptor negative cancers have fewer treatment options and tend to grow faster than hormone receptor-positive cancers.

Among women with hormone receptor–positive tumors, the risk of death in blacks was twice that of whites (100% higher). The excess risk among black patients decreased to 25% when they were matched to white patients by demographics (age, year of diagnosis, and area of residence), comorbidities, insurance, tumor characteristics, and treatment. In other words, these factors together accounted for 75.0% of the total excess risk of death in black patients. Insurance accounted for 37% of the total excess, followed by tumor characteristics (23.2%), comorbidities (11.3%), and treatment (4.8%).

Among women with hormone receptor–negative disease, blacks had a 49.5% excess risk of death compared to whites. As with patients with hormone receptor–positive disease, the excess risk decreased when adjusted for demographics, other conditions, insurance, tumor characteristics, and treatment. These factors combined accounted for 63.6% of the total excess risk of death in blacks. Insurance accounted for 34.1% of the total excess, followed by tumor characteristics (22.0%), comorbidities (3.8%), and treatment (3.6%).

"We found that differences in insurance explained one-third of the total excess risk of death in nonelderly black women compared to white women diagnosed with early-stage breast cancer, while differences in tumor characteristics explained approximately one-fifth of the excess risk," write the authors. "Health policy makers should ensure that the benefits of important scientific advances in prevention, early detection, and treatment of breast cancer are made available to all women, especially black women, who experience an undue share of the mortality burden from this disease," they conclude. "Equalization of access to care in nonelderly black women could substantially reduce ethnic/racial disparities in overall mortality of women diagnosed with breast cancer."

  • Collaboration to promote 80% by 2018 and colorectal cancer awareness wins prestigious Scopy Award

    The American Cancer Society, Fight Colorectal Cancer, National Colorectal Cancer Roundtable (NCCRT), and advocate Katie Couric were recognized over the weekend with the 2017 SCOPY (Service Award for Colorectal Cancer Outreach, Prevention and Year-Round Excellence) Spirit of Collaboration Award for the awareness event held in New York City's Hard Rock Café on March 1. 

    If you recall, our Countdown to 2018 event featured Couric, whose first husband died of colon cancer at age 42, and actor Luke Perry, whose best friend's wife was diagnosed with the disease, interviewing lots of impressive people involved in the fight against colon cancer, including Rich Wender, MD, our chief cancer control officer.

    SCOPY awards are given each year by the American College of Gastroenterology to honor the most innovative and impactful community education programs aimed to raise awareness of colorectal cancer. 

    Emily Butler Bell, associate director of NCCRT, accepted the award on behalf of the American Cancer Society and the NCCRT at an award ceremony on Sunday in Orlando, Florida. 

    Details of all the award winners can be found here. 

    "The 2017 SCOPY Award Winners deliver yet another class of extraordinary initiatives, meeting the high bar established in past years," said Jordan J. Karlitz, MD, FACG, chair, ACG Public Relations Committee and associate professor of Clinical Medicine, Section of Gastroenterology and Hepatology, Tulane Cancer Center, New Orleans, LA. "Many projects exhibit zeal and a fervent, ongoing commitment to community service, public health, and the national screening goal of 80% of eligible adults by 2018." 

    Twenty-one projects were selected by a panel of three judges that included Dr. Karlitz; Patricia L. Raymond, MD, FACG, ACG Public Relations Committee, assistant professor of Clinical Internal Medicine, Eastern Virginia Medical School; and Eugenia Tsai, MD, GI Fellow, Tulane University School of Medicine.

    "Year after year, the GI community demonstrates its remarkable dedication to support colorectal cancer (CRC) prevention," said ACG President Carol A. Burke, MD, FACG. "The passion and dedication of ACG members to communicate the critical message of CRC screening and prevention is evident in every submission," she added. 

    PHOTOS: The top photo is from the Countdown event. From left, actress Karen Walsh, who was diagnosed with stage IV colon cancer at age 40; Candace Henley, a colon cancer survivor and founder of the Blue Hat Foundation, one of this year's 80% by 2018 National Achievement Award honorees, and journalist Katie Couric.Walsh died several months after the event. Pictured in the smaller image, from left, is Danielle Burgess, director of communication for Fight Colorectal Cancer, and Emily Butler Bell, MPH, associate director, National Colorectal Cancer Roundtable.

  • ACS report: Breast cancer death rates down 39% since 1989

    ​A new report from the American Cancer Society finds that death rates from breast cancer in the U.S. have dropped 39% between 1989 and 2015. This translates to 322,600 deaths avoided during those 26 years. African-American women still have higher breast cancer death rates than white women nationally.

    The steep declines in breast cancer death rates since 1989 are attributed to improvements in treatment and early detection by mammography. Unfortunately, not all women have benefited equally from these improvements. A striking divergence in long-term breast cancer mortality trends between black and white women emerged in the early 1980s and continued to widen over the last several decades, but recent data suggest that the racial disparity may be stabilizing.

    The findings come from Breast Cancer Statistics, published in "CA: A Cancer Journal for Clinicians" and its companion consumer publication Breast Cancer Facts & Figures 2017-2018, reports published every two years by ACS to describe the latest trends in breast cancer incidence, mortality, survival, and screening by race/ethnicity, as well as current information on risk factors, prevention, early detection, treatment, and research.

    Breast cancer is the most common cancer among women in the U.S., after skin cancer. By the end of 2017, an estimated 252,710 women will be diagnosed with breast cancer. It is the second leading cause of cancer death among women in the U.S., after lung cancer; 40,610 women in the U.S. are expected to die from this disease in 2017.

    Breast cancer risk generally increases with age. About 8 of every 10 new breast cancer cases and almost 9 of every 10 breast cancer deaths are in women 50 years old and older.

    Number of breast cancer survivors in U.S.

    On January 1, 2016, more than 3.5 million women were living in the U.S. with a history of breast cancer. Some of them were cancer-free, while others still had evidence of cancer and may have been undergoing treatment.

    Race and ethnic factors

    White women and black women have higher breast cancer incidence and death rates than women of other racial and ethnic groups. Asian and Pacific Islander women have the lowest incidence and death rates.

    Racial differences nationwide

    White women get breast cancer at a slightly higher rate than black women. During 2010 through 2014, the overall incidence rate was 2% higher in white women. But black women are more likely to get breast cancer before they are 40, and are more likely to die from it at any age. They also have higher rates of triple negative breast cancer, which as an aggressive kind of breast cancer with lower survival rates. The breast cancer death rate during 2011 through 2015 was 42% higher in black women than in white women.

    Racial differences by state

    Breast cancer death rates are higher in black women than white women in every state. The excess death rate among black women ranges from 20% in Nevada to 66% in Louisiana. However, seven states did not have statistically significant differences in death rates.  In 4 of those states (Iowa, Minnesota, Nebraska, and Rhode Island), the similar death rates may be because the numbers of deaths among black women were very small, making it harder to compare. In three states (Massachusetts, Connecticut, and Delaware), the authors say the closing gap may represent improvements in access to health care.

    According to Carol DeSantis, MPH, our director, Breast and Gynecological Cancer Surveillance, "A large body of research suggests that the black-white breast cancer disparity results from a complex interaction of biologic and nonbiologic factors, including differences in stage at diagnosis, tumor characteristics, obesity, other health issues, as well as tumor characteristics, particularly a higher rate of triple negative cancer.

    "But the substantial geographic variation in breast cancer death rates confirms the role of social and structural factors, and the closing disparity in several states indicates that increasing access to health care to low-income populations can further progress the elimination of breast cancer disparities."

    Prevention and early detection

    The overall declines in breast cancer death rates since 1989 have been attributed to both improvements in treatment and early detection by mammograms. Following American Cancer Society guidelines for breast cancer screening can help women find breast cancer earlier when treatments are more likely to be effective.

    Women can help lower their risk of breast cancer by making healthy lifestyle changes.

    • Get to and stay at a healthy weight. Studies show obesity and excess weight increase the risk of developing breast cancer. Losing even a small amount of weight has health benefits and is a good place to start.
    • Be physically active. Growing evidence suggests that women who get regular physical activity have a lower risk of breast cancer compared to women who get no exercise. Doing even a little physical activity beyond your regular daily routine can have many health benefits.
    • Limit alcohol. Many studies have confirmed that drinking alcohol increases the risk of breast cancer in women. If you do drink alcohol, the American Cancer Society recommends women limit themselves to no more than 1 drink per day.

  • ACS awards 78 grants totaling nearly $40 million in second of two cycles for 2017

    ​The American Cancer Society, the largest non-government, not-for-profit funding source of cancer research in the U.S., has approved funding for 78 research and training grants totaling $39,836,250 in the second of two grant cycles for 2017.

    The grants will fund investigators at 57 institutions across the country; 63 are new grants while 15 are renewals of previous grants. The grants go into effect January 1, 2018. Here is the full list.

    Two individuals have been awarded the prestigious five-year renewable American Cancer Society Research Professorship:

    • Johannes Walter, PhD of Harvard Medical School in Boston will use cell extracts to investigate the collisions between molecules that create DNA damage that leads to cancer. By better understanding this process, he hopes to shed light on the DNA repair process, even identifying new proteins involved in repair. These proteins and processes can lead to the development of cancer but this research may also identify new susceptibilities to potential chemotherapeutic drugs.
    • David M. Sabatini, MD, PhD of Whitehead Institute for Biomedical Research looks to maximize the precise targeting of cancer drugs into the relevant tissues by exploiting the specificity of transport proteins embedded in lipid membranes on the surface and within cells. If successful, this approach could address a major challenge in drug delivery and could lead to safer and more effective cancer therapies.

    Two American Cancer Society Research Professors were renewed for five-year terms. They are: David Largaespada, PhD of the University of Minnesota, and Yang Shi, PhD of Boston Children's Hospital. 

    Highlights of the work being done by six of researchers whose grants will take effect Jan. 1, 2018

    • Andrea J. Berman, PhD, of The University of Pittsburgh is investigating how a protein called LARP1 physically interacts with other molecules in ovarian cancer cells to cause cell growth. By understanding the structure of this protein, potential new drugs could be developed to inhibit cancer growth.
    • Paula Hurley, PhD, of Johns Hopkins University in Baltimore will look at the role of SPARCL1 gene expression in prostate cancer. The lack of this gene's expression has been linked to a higher risk of metastatic recurrence and death from prostate cancer. The team has shown that SPARCL1 functions as a barrier to local tumor progression and metastatic development. They hope the work will lead to a better understanding of how cancers metastasize, and potentially lead to therapeutics specifically targeting SPARCL1.
    • Kian-Huat Lim, MD, PhD, of Washington University, St. Louis and team will build upon their recent finding that pancreatic cancer cells use their innate immunity to armor themselves, a self-defense mechanism that is usually summoned when cells are injured or invaded by microorganisms, making them highly aggressive and resistant to chemotherapeutics and immunotherapy. They will explore whether the defense mechanism can be deactivated using the master switch that controls the innate immune pathway. If successful, the work could yield a highly promising therapy for a cancer with few treatment options.
    • Xuehong Zhang, MD, ScD, of Brigham and Women's Hospital in Boston will assess the role of yogurt intake in relation to the risk of colorectal cancer (CRC). While laboratory evidence suggests a beneficial role of yogurt in colorectal cancer, relevant human studies to date are limited, subject to potential bias, or have examined overall dairy intake, not yogurt specifically. Building upon their preliminary data showing a significant reduction in CRC risk associated with yogurt intake, they will further assess the association in other existing databases.
    • Abby Rosenberg, MD, MS, of Seattle Children's Hospital will examine whether a brief, one-on-one intervention targeting stress-management/mindfulness, goal-setting, positive reframing, and meaning-making can address poorer psychosocial outcomes seen among adolescent and young adult (AYA) cancer patients. Cancer among AYAs is particularly difficult because the age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Findings from this research will aid in the development of larger, multi-center clinical studies designed to test the intervention among AYAs seeking to improve patient and family well-being and potentially extending life and reducing the burden of illness.
    • Joann B. Sweasy, PhD, of Yale University will oversee a three-year grant supporting the work of young faculty at Yale. The grants provide essential seed support for beginning researchers, support that may often help tip the balance of a nascent research career toward devoting special attention to the cancer problem.                   

    A little history

    Since 1946, the American Cancer Society has funded research and training of health professionals to investigate the causes, prevention, and early detection of cancer, as well as new treatments, cancer survivorship, and end of life support for patients and their families. In those 71 years, the American Cancer Society's extramural research grants program has devoted more than $4.6 billion to cancer research and is honored to have given funding to 47 investigators who went on to win the Nobel Prize.

    Pay-ifs worthy of funding if money becomes available

    The Council for Extramural Research also approved 80 grant applications totaling $44,075,250 that could not be funded due to budgetary constraints. These "pay-if" applications represent work that passed the Society's multi-disciplinary review process but are beyond the Society's current funding resources. They can be and often are subsidized by donors who wish to support research that would not otherwise be funded. In 2016, more than $9 million in additional funding helped finance 35 "pay-if" applications.

    For more information about the American Cancer Society Research Program, please visit cancer.org/research.




  • Rapper Offset launches $500K fundraising campaign for ACS

    The American Cancer Society is excited to announce a new partnership with Offset, of the chart-topping hip-hop trio Migos. The rapper and artist is mobilizing his friends, corporate sponsors, and passionate fans to raise $500,000 to help us promote cancer prevention and access to care in underserved communities. In addition, money raised will help fund an ACS Research Grant focused on bladder cancer research.

    Offset's dedication to attacking cancer from every angle is personal. His inspiration for working with the American Cancer Society is his late grandmother, Sallie Ann Smith, a significant role model in his life who died of bladder cancer in 2012. After Mrs. Smith's cancer diagnosis, her family learned firsthand about the positive impact the American Cancer Society programs and services make on families. Offset has a long family history of volunteerism with the American Cancer Society. His mother, Latabia Woodward, has been an American Cancer Society Relay For Life supporter and volunteer for over a decade.

    The Offset partnership is one example of the Society's efforts to forge new relationships and ultimately, to reach new audiences. It will advance the priorities of the new American Cancer Society by increasing reach, relevance, and revenue, particularly with younger audiences. For example, as the 2017 BET Award winner, Offset is dominating in social media. He has more than 3.2 million Instagram followers. By leveraging his network, this campaign will engage an entirely new group of constituents. 

    Tuesday, September 19, ACS and Offset formally launched the relationship through nationwide news outreach, social media, and cancer.org. Offset hosted a launch party at Main Event Entertainment in Atlanta, providing a media opportunity and platform for him to call on friends, fans, and sponsors to donate. His Migos bandmates, Takeoff and Quavo, as well as representatives from their label, Quality Control, joined him as he spent the day bowling, and playing laser tag and video games with teens and young adults whose lives have been impacted by cancer. View the short video he posted on his Instagram page.

    "We are honored that Offset chose to work with us. His inspiration and support for the American Cancer Society is one that makes him a unique artist – one who wants our world to be better," said Sharon Byers, our chief development and marketing officer. "Offset's fundraising campaign is a significant opportunity to honor his family while leveraging the music industry and his contacts to support our mission. It's a win-win." 

    To join Offset's fundraising campaign, visit prizeo.com/offset. For more information about Offset's work with ACS, please go to cancer.org/offset.

  • CVS Health Foundation, ACS, & Truth Initiative announce grants to help U.S. colleges go tobacco-free

    The CVS Health Foundation, American Cancer Society, and Truth Initiative today announced that grants are now available to help U.S. colleges and universities advocate for, adopt, and implement 100 percent smoke- and tobacco-free campus policies. The grants are part of aggressive efforts by all three organizations to deliver the first tobacco-free generation by accelerating and expanding the number of campuses across the country that prohibit smoking and tobacco use.

    The announcement of newly available grants coincides with the awarding of $1.2 million in grants to 126 schools that are working toward a tobacco-free campus policy, the largest number of schools to do so at any one time. Spanning the U.S., the campuses include 43 major academic institutions, including Stanford University and University of Pittsburgh; 34 Historically Black Colleges and Universities (HBCUs), including Howard University; and 49 community colleges. Grantees range from colleges in the early stages of building campus support for going tobacco-free to those that have adopted policies and need support to successfully implement them.

    The grants delivered through Truth Initiative and ACS are part of Be The First, CVS Health's five-year, $50-million initiative that supports education, tobacco control, and healthy behavior programming with a goal of helping to deliver the nation's first tobacco-free generation. CVS Health's efforts targeting college students meet an urgent and critical need. Of the roughly 20 million college and university students in the U.S., more than 1 million have been projected to die prematurely from cigarette smoking.

    "We are at a critical moment in our nation's efforts to end the epidemic of smoking and tobacco use, and expanding the number of tobacco-free college and university campuses is an important step in our efforts," said Eileen Howard Boone, president of the CVS Health Foundation. "We're confident our strategy will drive a significant decline in the number of new college-age smokers, and contribute to the progress being made where a tobacco-free generation in the U.S. seems possible."

    With the CVS Health Foundation's support, ACS and Truth Initiative programs help students, faculty, and staff develop and execute strategies that are customized to meet the campuses' unique needs and move the schools toward a 100 percent smoke- and tobacco-free environment. Each organization also provides technical assistance and other resources to schools, including education, communications, support to quit smoking, and evaluation. 

    According to a new survey from CVS Health, public support for smoke- and tobacco-free campus policies remains strong. The results released today revealed that 3 in 4 Americans (73%) and 8 in 10 current U.S. college students (78%) indicated their support for policies that prohibit smoking and other tobacco use on college campuses. At the same time, 57% of U.S. college students say a tobacco-free campus is important to them when considering applying to or attending a college. The findings come from a public opinion poll conducted by Morning Consult for CVS Health in August 2017. For more findings, visit cvshealth.com/CampusSurvey.

    "While we have made great progress driving down the smoking rate to 6 percent among youth, the prevalence of smoking by young adults is 14.2 percent and those who attend college have a higher risk of initiating and experimenting with smoking," said Robin Koval, CEO and president of Truth Initiative, the national public health organization that directs and funds the truth campaign.  "With 99 percent of smokers starting before age 26, college campuses are critical in preventing young adults from starting tobacco use, aiding current smokers in quitting, and reducing exposure to secondhand smoke for all. We are thrilled to be working with the CVS Health Foundation to provide grants to minority-serving institutions, HBCUs, and community colleges to give them the tools to go tobacco-free and be the generation that ends smoking."

    "Tobacco is the single largest preventable cause of disease and premature death in the United States. Cigarette smoking is responsible for approximately 30 percent of all cancer deaths, killing up to half of its users," said our CEO Gary Reedy. "By partnering with the CVS Health Foundation to create tobacco-free campus environments, we can reduce youth tobacco exposure, prevent students from becoming addicted, and ultimately, reduce the number of people who get sick and die from cancer and other tobacco-related diseases." 

    Since the launch of its tobacco-free college program in 2016, the CVS Health Foundation has awarded more than $3 million in grants to 146 U.S. colleges and universities. The U.S. Department of Education reports there are approximately 4,700 U.S. colleges and universities, many of which have more than one campus. Yet, only 1,611 campuses are 100-percent smoke- and tobacco-free, according to an Americans for Nonsmokers Rights analysis.

    To see the full list of colleges supported by these grants and for more information on the grant application process, please visit cvshealth.com/tobaccofreecampus.

  • Watch highlights of The Washington Post's Chasing Cancer Summit

    Our own Otis Brawley, MD, our chief medical officer, was among the experts The Washington Post gathered for its"Chasing Cancer Summit" that was livestreamed on Sept. 18. You can watch a variety of video highlights here.

    During this two-hour summit, leaders and members of the American Association for Cancer Research (AACR) came together in Washington, D.C., to discuss the latest advances in cancer detection and treatment. The AACR and Genetech were presenting sponsors.

    During this two-hour summit, these experts examined how the U.S. health-care system is being shaped by a disease that touches the lives of millions, and provide new insights on addressing the range of challenges cancer presents.

    Here is summary put together by the Post: 

    • U.S. Food and Drug Administration Commissioner Scott Gottlieb said the FDA’s recent approval of CAR T-cell therapy is a “significant milestone” and discussed the hundreds of new applications for active gene therapy products.
    • Gottlieb also spoke about the FDA’s new initiative to reduce the amount of nicotine in cigarettes to minimally addictive or non-addictive levels so “we don’t hook a whole new generation of smokers to cigarettes.”
    • Tom Whitehead of the Emily Whitehead Foundation shared the emotional story of his daughter, Emily’s, cancer diagnosis. Emily Whitehead joined the panel, which included Children’s Hospital of Philadelphia Attending Physician Shannon Maude, and National Cancer Institute Associate Research Physician Nirali Shah, to talk about what it was like to be the first pediatric recipient of experimental gene therapy for cancer.
    • National Cancer Institute Acting Director Douglas Lowy talked about the Cancer Moonshot, including how long-term, bipartisan political support is important for greater advances in clinical trials.
    • Top medical experts in the field, including American Cancer Society Chief Medical Officer Otis Brawley, MIT Professor Regina Barzilay, and Color Genomics’ Chief Medical Officer Jill Hagenkord, discussed what can be achieved in the year ahead in cancer detection and treatment.

    Dr. Lowy of NIC predicted that "we will end up in an era where precision of cancer screening will go up, and the range of cancers for which we have testing will also go up. We'll see incremental improvements in this area, and some of them may be dramatic," he said.

    Dr. Brawley said he foresees a time soon when we will have a blood test that detects cancer by looking for circulating DNA fragments. He said he hopes that new cancer tests will be validated to show they save lives before they are implemented in the population. He said we should avoid launching cancer tests that are discovered 20 years later not to save lives.

    The program was produced by Washington Post Live, a unit of the The Washington Post newsroom that provides a live journalism platform for government officials, business executives, global thought leaders, and various newsmakers. 

  • ACS releases breast cancer guidebook in Spanish

    The American Cancer Society today announced the publication of "Cáncer de Seno Claro y Sencillo," an engaging question-and-answer book written to help newly diagnosed patients quickly digest the crucial information needed to navigate diagnosis and treatment. 

    "Cáncer de Seno Claro y Sencillo" was written to help women with breast cancer and their caregivers know what to expect, what to do, and how to get through what can be an overwhelming, life-changing experience. Professional illustrations throughout the book can help patients understand how breast cancer starts in the body, facts about breast anatomy, the lymph system, and the pros and cons of breast reconstruction. 

    "A diagnosis of breast cancer can be a profoundly anxious experience. This book supports patients by providing comprehensive,  easy-to-understand information to help them navigate through their diagnosis and treatment options, especially during those first days and months," said Carmen E. Guerra, MD, (pictured here), a member of our ACS Board of Directors. She re-recorded sound bites about the book in Spanish and English for use by the media.

    Written by medical experts from the Society, with guidance from breast cancer survivors, this 212-page evidence-based book can be a useful resource for any breast cancer patient. 

    "This book is an important and innovative tool to support patients with a breast cancer diagnosis, and can help them make the choices that are right for them," said  J. Leonard Lichtenfeld, MD, our deputy chief medical officer.

    Breast cancer remains the most frequently diagnosed cancer in women. This year, invasive breast cancer will be diagnosed in about 252,710 women. An additional 63,410 new cases of in situ breast cancer will be diagnosed. 

    How to order

    "Cáncer de Seno Claro y Sencillo" is available in both print and eBook formats, and available in an English version, as well. Members of the public can order this book at cancer.org/bookstore. For bulk order requests, they should email trade.sales@cancer.org. The price is $14.95. 

    The English version, "Breast Cancer Clear & Simple, Second Edition: All Your Questions Answered," was published last August. It has won multiple industry awards, including Gold Medal, Independent Publisher Book Awards; Silver Medal, Benjamin Franklin Awards; Winner, USA Best Book Awards; Honorable Mention, Foreword Indies Book of the Year; and Finalist, EXCEL Awards.

  • FDA approves first gene therapy in the U.S. and ACS played a part

    You may have heard news reports about the U.S. Food and Drug Administration (FDA) approving Kymriah (tisagenlecleucel) for certain children, adolescents, and young adults with a form of acute lymphoblastic leukemia (ALL). It's a big deal, as it is the first gene therapy available in the U.S.

    “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” announced FDA Commissioner Scott Gottlieb, MD, on August 30. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses."

    What you didn't hear is that ACS funded scientific work that helped lead to the development of Kymriah. A small amount of our funding was for the initial clinical trials that provided evidence that helped the FDA decide to designate the new treatment as a breakthrough therapy and to speed its evaluation and approval for market.

    Kymriah is a type of CAR T-cell therapy designed to help the body’s own immune system fight cancer. Each dose is customized to the individual patient. It’s made using a patient’s T-cells, a type of white blood cell that helps fight diseases in the body. The T-cells are collected from the patient and sent to a special lab where they are genetically changed in a way that programs them to find and kill leukemia cells. They are then given back to the patient through an infusion. The modified cells can circulate in the body for years, seeking out and destroying leukemia cells. 

    The drug is approved for young people ages 3 to 25 years who have B-cell precursor ALL that has not gotten better, or has come back at least twice after standard treatment.

    Kymriah was developed at the University of Pennsylvania lab of Carl H. June, MD. The treatment is being marketed by the pharmaceutical company Novartis. Back in 2012, Novartis and the University of Pennsylvania entered into a global collaboration to further research, develop, and commercialize CART-cell therapies, including Kymriah.

    Our Role

    The American Cancer Society provided grant funding to at least two scientists who contributed significant work to the development of Kymriah -- Stephan Grupp, MD, PhD, a researcher and oncologist at the Children’s Hospital of Philadelphia (CHOP), and  David T. Teachey, MD, who in 2014 led an early-stage clinical trial at CHOP (making CHOP the first institution to investigate Kymriah in the treatment of pediatric patients) that examined the efficacy and safety of the treatment. 

    Grupp received ACS funding from 2005 to 2008. That grant helped support Grupp’s development of the mouse models needed to advance the development and testing of the treatment that would become Kymriah. Grupp’s initial findings were published in the journal Blood in 2005, and additional research was published in the same journal in 2008. Grupp personally acknowledged the significance of this American Cancer Society funding in a 2017 email: 

    “Although not apparent from the title of the grant, that grant was actually quite important in the pre-clinical run up to CAR-T cell clinical trials. We had used the  support of the ACS to develop a wide range of leukemia xenograft models, which were used in our signal transduction experiments. This left us in an immediate position to move on necessary IND enabling experiments in the lab with CAR-T cells directed against CD19. The availability of these models saved us a year in pre-clinical development.”

    In 2009, Carl June at UPenn published the findings from his studies of Kymriah in human T-cells that had been injected into the mouse models that were developed by Grupp. These pre-clinical trials provided the evidence necessary to move forward with clinical trials in humans. In 2011, June and his colleagues performed the first clinical trial of Kymriah to assess the safety and feasibility of the treatment. The findings from June’s study led to additional clinical trials involving Teachey, another ACS grantee. His early-stage clinical trial, in which more than 90% of patients achieved a complete remission one month after receiving the therapy, led to larger clinical trials.

    The results of these and additional Novartis clinical trials culminated in the August 2017 FDA approval of Kymriah.

    Kymriah can cause severe side effects, and treatment with Kymriah will be available only at specially certified hospitals and clinics.

    For more information . . .

    Read Stacy Simon's news story on cancer.org about the FDA approval of Kymriah, and an earlier story by Elizabeth Mendes in which she interviewed Leonard Lichtenfeld, MD, MACP, our deputy chief medical officer, about the drug.    
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