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Letter on USPSTF Draft Research Plan for Breast Cancer Screening

February 17, 2021

Alex H. Krist, M.D., M.P.H.
Chairperson, U.S. Preventive Services Task Force
5600 Fishers Lane
Mail Stop 06E53A
Rockville, MD 20857

Re: USPSTF Draft Research Plan on Breast Cancer Screening

Dear Dr. Krist:

I am writing to you on behalf of Susan G. Komen (Komen) to provide feedback on the U.S. Preventive Services Task Force (USPSTF) Draft Research Plan for Breast Cancer Screening.

Komen is the world’s leading nonprofit breast cancer organization representing the millions of women and men who have been diagnosed with breast cancer. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts—we advocate for patients, drive research breakthroughs, improve access to high quality care, offer direct patient support and empower people with trustworthy information. Komen is committed to supporting those affected by breast cancer today, while tirelessly searching for tomorrow’s cures. We advocate on behalf of the estimated 264,200 women and men in the United States who will be diagnosed with breast cancer and the more than 44,130 who will die from the disease in 2021 alone.

Komen offers the following comments for your consideration.

Comments related to Key Questions to be Systematically Reviewed
Science and clinical practice have moved beyond the “one-size-fits-all” approach to breast cancer screening and treatment, and we applaud USPSTF for its efforts to examine the comparative effectiveness of different breast cancer screening strategies, particularly those based on personalization of risk factors.

We strongly urge the USPSTF to focus on the continuum of risk across all age groups and to match its screening recommendations to the level of risk. To fail to consider the continuum of risk makes recommendations much less useful and has the potential to contribute to women’s confusion about whether and how frequently to be screened.

We recommend further defining the continuum of risk and providing more context on what is meant by “low,” “average,” and “high” risk. This added detail could assist women and their providers in determining where a woman falls along the risk continuum.

In addition, as part of the systematic evidence review, USPSTF mentions “personalization based on risk factors.” Therefore, USPSTF should describe which risk assessment tools are used to assess lifetime risk of breast cancer. Different tools use different combinations of risk factors and data sets to estimate risk so each tool could produce different risk estimates for the same woman. Therefore, this additional detail on the tools themselves is important for patients and providers.

When assessing effectiveness of different screening strategies by population, we encourage USPSTF to control for other population characteristics to the extent possible. For example, when analyzing the effectiveness of screening modalities by age, controlling for, or further stratifying by, other factors such as breast density or race/ethnicity could provide further insights into the comparative effectiveness by population or subpopulation.

With regard to measuring the comparative effectiveness of different breast cancer screening strategies on the incidence of advanced breast cancer, we also strongly recommend that USPSTF provide more detail on how it defines advanced breast cancer as this can be defined in a variety of ways. Most breast cancer patients use the term “metastatic breast cancer” to define “advanced” or Stage IV breast cancer that has spread to distant parts of the body. However, in some contexts “advanced breast cancer” also includes locally advanced or stage 3 breast cancers. Clarification on the definition used by the USPSTF is needed.

Finally, while we understand that consideration of the harms of routine mammography is a part of the systematic review, potential harms may be overestimated as they are often based on subjective assessments. Hence, we caution the panel to acknowledge that the subjective harms may vary from individual to individual.

Comments related to Contextual Questions
Komen applauds the USPSTF for including important questions about the role of structural racism, social inequalities, and other factors that drive breast health disparities, especially in the Black community. Looking through the lens of different races and ethnicities throughout this framework is critical for solving the issue of inequal access, uptake and outcomes of screening.

For example, in analyzing how women determine the harms and benefits of screening, Komen suggests consideration of their beliefs about the risk of developing breast cancer in addition to their personal preferences. Such examination should factor in race and ethnicity as studies have shown that beliefs regarding the risks associated with screening may differ among population groups.

Regarding analysis of the benefits and harms of screening mammography, Komen recommends expanding this to include any conclusions that can be drawn from a comparison of two-dimensional mammography versus three-dimensional mammography.

Komen also recommends providing more detail on how USPSTF will define “average risk” and details for risk stratification when examining risk assessment tools. If average risk is defined at too high a level, evidence may be skewed, reducing the utility of the recommendations for the general population. Alternatively, using too low of a cutoff may preclude an assessment of the effect of some risk factors (e.g., family history) on the effectiveness and harms of routine breast cancer screening.

Additionally, as noted above, risk assessment tools should be assessed for their performance in women of different races and ethnicities, as well as for younger women.

We also know that many women do not have regular mammography screening (, so the analytical framework should account for what factors are shaping decisions to be screened and what interventions are effective in getting women to adhere to screening recommendations. Finally, Komen recommends delineating what is meant by “older” and “younger” women in these contextual questions more clearly.

Comments related to Proposed Research Approach
With regard to outcomes for key questions reviewed, Komen recommends consideration of the stage of diagnosis of invasive breast cancer. For patients, there is a big difference between local treatment for early breast cancer and the need for systemic therapy for later stage diagnosis. The stage at diagnosis (not just using the phrase “advanced breast cancer” as the proposal suggests) factors into the adverse effects of treatment and quality of life in addition to survival. Therefore, we urge USPSTF to provide more detail on how invasive breast cancer will be defined in the evaluation of outcomes.

Finally, we recommend that a medical oncologist(s) with specific expertise in breast cancer and breast cancer patient advocate(s) participate in the development and/or expert review of the evidence reports.

Komen appreciates the opportunity to comment on this important work and looks forward to working with the USPSTF throughout the process of updating the breast cancer screening recommendations. If you have any questions, or we may be of further assistance, please do not hesitate to reach out to Molly Guthrie, Senior Director of Public Policy and Advocacy, at

Victoria A.M. Wolodzko
Senior Vice President, Mission
Susan G. Komen