A national study evaluating a personalized approach to breast cancer screening and risk assessment has launched a new effort to diversify its participants, as it hits a milestone of 30,000 women enrolled.
The multiyear WISDOM study (Women Informed to Screen Depending on Measures of risk), led by UC San Francisco and the Athena Breast Health Network, will use a new, $9 million grant from the National Cancer Institute to increase ethnic diversity, as it works toward the goal of enrolling 100,000 or more women overall.
The study is being conducted nationwide in conjunction with five University of California medical centers, Sanford Health, and partners across the country.
Open to women between 40 and 74 who have not had breast cancer, the study evaluates two approaches to breast cancer detection: standard annual mammography, versus a personalized approach that takes multiple risk factors into consideration, including genetic markers and breast density, to make a recommendation about when to start or stop and how often to screen for breast cancer, and what type of imaging to use.
“We now know that all breast cancers are not the same – and today we don’t offer the same therapies for every woman,” said Laura Esserman, MD, MBA, director of the UCSF Carol Franc Buck Breast Care Center who leads the overall project. “This study tests the concept that one-size-fits-all might not be the right strategy for breast cancer screening and prevention either, especially because we know that all women do not have the same risk. Instead, we have developed an approach to determine how best to screen based on each woman’s risk, so we can do more for those at high risk, and less for those at lower risk.”
Despite continued advances in cancer care, approximately 42,000 women a year still die of breast cancer and about 1 in 8 U.S. women are expected to develop invasive breast cancer in her lifetime, according to Breastcancer.org. For American women, breast cancer death rates are higher than any other cancer except lung cancer.
Risk assessment is particularly important among women of color, who are more at risk for lethal cancers. Even though women of color have slightly lower risk of getting breast cancer, they are 40 percent more likely to die of breast cancer than white women if they are diagnosed. In an effort to better identify those at highest risk in these communities, WISDOM has tapped Kim Rhoads, MD, MS, MPH, associate director for community engagement at the UCSF Helen Diller Family Comprehensive Cancer Center, to lead the national effort to recruit women across diverse backgrounds, ethnicities and geographic locations.
The effort will include partnerships with medical centers nationwide, including Louisiana State University, University of Chicago and Ingalls Memorial Hospital, in Illinois, University of Alabama, and Topline MD, in Florida.
“Minority women may be diagnosed with more aggressive breast tumors at younger ages,” said Rhoads. “Screening guidelines based on our understanding of breast cancer in white women may fail to achieve best outcomes in diverse populations. The WISDOM study will help us better understand the behavior of breast cancer in women of color, and tailor personalized and effective screening guidelines that will detect tumors easily and narrow a longstanding disparities gap.”
When the gold standard of annual screening for breast cancer began in the mid 1980s in the United States, it was assumed that all women were at risk for the same cancer. The hope was that if all cancers could be detected earlier, the risk of more aggressive cancers would be eliminated. However, despite widespread screening, women continue to develop aggressive cancers, while many more innocuous cancers are being detected that might not otherwise come to clinical attention.
Esserman said screening guidelines need to change to reflect medicine’s growing knowledge. But basic concepts are still being debated, such as when screening should begin, how often to screen, and what imaging to use. Some guidelines recommend screening begin at age 40, while others recommend age 45 or even 50.
“This conflict by the experts is based on old data,” says Esserman. “Why are we screening everyone as if they are all at risk to get the same cancer? What we need is a modern-era screening study, using all we know and all we have learned to find a better path forward and to integrate screening with prevention.”
The study design itself is highly unusual: participants can elect to be assigned randomly to the annual screening arm or to the personalized risk assessment, or choose which arm of the study they prefer to join. The personalized arm includes a risk assessment tailored to different ethnicities, that is based on family history, exposures, breast density, co-morbidity and genetic predisposition. It leads to an overall score that allows physicians to determine when to start screening, when to stop, how often, and what type, all of which stay within recommendations of one of the guidelines.
“Most women spend 30 to 35 years getting breast screenings,” said Esserman, a UCSF professor of surgery and radiology. “So we recommend that women join the WISDOM study, and spend the next 5 years helping us create a better future where we can learn how best to target both screening and prevention. Now, more than ever in this era of COVID, it’s important for women to understand their personal risk and to know how often they should screen.”
WISDOM is supported by the Patient Centered Outcomes Research Institute, the National Cancer Institute, the University of California, and other foundational programs.
UCSF Health is recognized worldwide for its innovative patient care, reflecting the latest medical knowledge, advanced technologies and pioneering research. It includes the flagship UCSF Medical Center, which is ranked among the top 10 hospitals nationwide, as well as UCSF Benioff Children’s Hospitals, with campuses in San Francisco and Oakland, Langley Porter Psychiatric Hospital and Clinics, UCSF Benioff Children’s Physicians and the UCSF Faculty Practice. These hospitals serve as the academic medical center of the University of California, San Francisco, which is world-renowned for its graduate-level health sciences education and biomedical research. UCSF Health has affiliations with hospitals and health organizations throughout the Bay Area.