Study to evaluate breast cancer screening approaches amid mammography guidelines debate

In Clinical Trials by Barbara Jacoby

From: healio.com

Mammography remains a controversial topic among medical societies, with conflicting guidelines on what age women should start and how frequently they should undergo screening.

In April, the American College of Physicians recommended most women undergo mammography every other year, instead of yearly. The American College of Radiology disagreed, suggesting this would result in thousands of unnecessary breast cancer deaths.

New guidelines also are expected from the FDA. In March, the agency proposed a requirement that mammography facilities provide information on risks associated with dense breasts to help women make better decisions regarding breast health.

In an effort to determine the safety of screening based upon personalized risk, investigators for the randomized WISDOM study will compare a comprehensive risk-based, or personalized, approach with traditional annual breast cancer screening among 100,000 women aged 40 to 74 years. Of note, no woman will be screened less than recommended by U.S. Preventive Services Task Force guidelines, which call for biennial screening mammography for women aged 50 to 74 years.

Noninferiority with respect to the number of late-stage cancers detected will serve as the primary outcome of the study, which is expected to be completed by December 2020.

HemOnc Today spoke with Jeffrey Hawley, MD, diagnostic radiologist at The Ohio State University Comprehensive Cancer Center, about the various recommendations and the major differences among them, what needs to be examined in order to establish clearer recommendations, and what new insights the WISDOM study may yield.

Question: What are the basics of the recommendations ?

Answer : The American College of Radiology and the Society of Breast Imaging both recommend average-risk women start mammography at age 40 years and continue as long as women are in good health. These recommendations are similar to those of the NCCN and the American Society of Breast Surgeons. However, the American College of Physicians and USPSTF recommend starting screening at about age 50 years.

Q: Why are there differing opinions on when women should begin and how often they should undergo mammography ?

A: The American College of Radiology and Society of Breast Imaging base their recommendations on an individual perspective. The societies want to do their best to give people the most benefit in mortality reduction, and that is going to be derived by screening annually as long as patients are in good health. The recommendations that suggest less frequent screenings take an ‘economy approach,’ in which they tend to focus on some of the negatives that are associated with screening.

Q: What needs to be assessed in order for there to be clearer recommendations?

A: There needs to be better understanding of what is out there in terms of scientific data. Screening recommendations are a very divisive issue, as there are strong opinions on both sides about overdiagnosis, the effect of false-positives and more. The technology has certainly changed for the better — we find more cancer now with improved technology and we call back fewer people for additional imaging.

Q: What do you hope the WISDOM trial will provide in terms of new insights into screening recommendations ?

A: Anything that we can do to make women aware of their personal risk factors for breast cancer is certainly a good thing. However, there is some skepticism from the radiology community about how the trial is designed and some of the assumptions that are made with the data they accept as accurate. I am not sure that it is not going to be just another point of division based upon some of the early critiques.

Q: With that said, what should clinicians take away from this ?

A: We all agree that there are benefits and risks with screening or not screening. Women should weigh these risks and benefits and decide what method of screening is best for them — including when to start and how often to screen. To experience the greatest benefit of screening and save the most lives, the annual screening method is best. Hopefully primary care physicians can sit down and have evidence-based discussions with their patients about their values and what might be best specifically for them. – by Jennifer Southall