News | Breast Imaging | June 15, 2023

ACR and SBI Issue Joint Comments on USPSTF Breast Cancer Screening Draft Recommendations

The American College of Radiology (ACR) and Society of Breast Imaging (SBI) has submitted joint comments in response to the United States Preventive Services Task Force (USPSTF) draft recommendations for breast cancer screening. The combined comments acknowledged the proposed move toward screening average risk women beginning at age 40 is a step in the right direction, while objecting to other aspects of the Task Force’s recommendations.

The American College of Radiology (ACR) and Society of Breast Imaging (SBI) has submitted joint comments in response to the United States Preventive Services Task Force (USPSTF) draft recommendations for breast cancer screening. Image courtesy: Getty Images

June 15, 2023 — The American College of Radiology (ACR) and Society of Breast Imaging (SBI) have submitted joint comments in response to the United States Preventive Services Task Force (USPSTF) draft recommendations for breast cancer screening, proposed in a May 9 statement. The ACR/SBI joing comments acknowledged that the proposed move toward screening average risk women beginning at age 40 is a step in the right direction, while objecting to other aspects of the Task Force’s recommendations.

The comments were sent to the United State Preventive Services Taskforce Agency for Healthcare Research and Quality on behalf of both organizations by Stamatia V. Destounis, MD, FACR, Elizabeth Wende Breast Care, who serves as Chair, Commission on Breast Imaging, American College of Radiology (ACR) and Mary S. Newell, MD, FACR, Emory University Winship Cancer Institute, who serves as President of the Society of Breast Imaging (SBI), as part of the ACR Breast Commission USPSTF Work Group. That group also includes: Lars J. Grimm, MD; Sarah M. Friedewald, MD, FACR; R. Edward Hendrick, PhD, FACR; and Bethany L. Niell, MD, PhD. The statement included feedback on key areas: Annual vs Biennial Screening; Overdiagnosis; Women Aged 75 and Older; Screening Breast MRI; and included a number of table and figures to reinforce the Work Group’s feedback.

In a June 8 statement from the American College of Radiology, ACR noted:

“The highly detailed and scientifically robust comments raise serious concerns with the proposed recommendation for biennial rather than annual screening, given the Task Force’s acknowledgement that annual mammography screening for women 40 and older saves the most lives and results in the greatest number of life years. ACR and SBI also expressed deep disappointment that the proposed USPSTF recommendation continues to perpetuate confusion surrounding when to cease mammographic screening by proposing a recommendation for screening mammography in women 75 and older. The associations’ position is that screening mammography should continue as long as a woman is in good health with reasonable life expectancy.”

The joint statement continued: “Comments provide an expository review of available science and rebut the Task Force’s approach and conclusions on multiple issues, while respectfully urging that it reconsider the evidence as detailed in the ACR/SBI comments and adopt final recommendations assigning a B grade for annual mammographic screening for all women ages 40 and older who are at average risk for breast cancer,” and noted that USPSTF will review submitted comments prior to issuing final recommendations at a later date.

A summary of specific areas of concern shared in the joint statement follows:

Annual vs. Biennial Screenings

The ACR/SBI statement offered this input: “We have serious concerns, however, with the proposed recommendation for biennial rather than annual screening given the Task Force acknowledgement that annual mammography screening for women forty and older saves the most lives and results in the greatest number of life-years gained – a fact demonstrated through Randomized Control Trials (RCT), Observational Trials and CISNET models. In addition, we are deeply disappointed that the proposed Task Force recommendation continues to perpetuate confusion surrounding when to cease mammographic screening by proposing an “I” recommendation for screening mammography in women 75 and older.

The ACR and SBI are concerned that no breast cancer experts or patient representatives were included on the panel. The Institute of Medicine (IOM) recommends that trustworthy guideline development should include a multidisciplinary panel of experts and representatives from key affected groups [3]. The IOM report suggests that such guideline development cannot assess the evidence in the same way that a multidisciplinary group can. The ACR and SBI believe that having breast cancer experts on the panel would, for example, have avoided the incorrect concept by the USPSTF regarding screening intervals affecting overdiagnosis.

We believe that the draft recommendations overemphasize the potential harms (potential risks) of breast cancer screening and underestimate the benefit of annual mammography starting at age 40 for the average-risk patient in reducing morbidity and mortality. The draft recommendations reflect a biased view of the available evidence, while the Task Force’s own modeling studies conclude annual screening confers a greater benefit. Accordingly, we respectfully urge you to reconsider the evidence (which was detailed in the statement) and adopt final recommendations assigning a B grade for annual mammographic screening for all women ages 40 and over who are at average risk for breast cancer. Finally, we respectfully request, along with the final document, comments submitted during the 30-day review period be addressed individually with explanations included for any comments not incorporated into the final guidelines. The public availability of this information is important for the transparency needed to establish trust.”

Screening in Women with Dense Breasts

The ACR/SBI joint statement also included a specific section on supplemental screening in women with dense breasts, offering the following:

“The USPSTF concludes that there is insufficient evidence to assess the balance of benefits and harms of supplemental screening with MRI (Magnetic Resonance Imaging) or ultrasound in women with dense breast tissue, giving an “I” grade. This is problematic as literature has proven that women with dense breast tissue have an increased risk for the development of breast cancer, and in addition, are at risk for a cancer being masked on screening mammography. Patients with extremely dense breasts are approximately two times as likely to develop breast cancer as patients with average density and 4-6 times as likely as patients with fatty breasts [27, 28]. The Task Force does note this. Breast density is recognized as a significant risk factor and has been included in the most up-to-date risk assessment tools. Additionally, the sensitivity of mammography is decreased in patients with dense breasts, which is a fact that is also acknowledged by the Task Force. Sensitivities for mammography are reported to be significantly lower in patients with dense breasts compared to patients with fatty breasts [29, 30, 31].

Currently, 43%-46% of US women aged 40 or over have dense breasts [2]. In a case-controlled analysis of the Dutch mammography screening data, a 41% mortality reduction in women with non-dense breasts was demonstrated compared to a 13% reduction in women with dense breasts [32], likely reflecting both the effect that breast density has on risk and its cancer masking effect (sensitivity). Therefore, if an equitable screening approach is desired (as conveyed in the Task Force document), patients with dense breasts should have access to supplemental screening so they can achieve screening benefits in a manner more fully in keeping with those of patients with less dense breasts.

The Task Force did not consider that annual screening mammography is especially important in women with dense breasts. Annual screening in this population reduces the chance of an interval cancer. By increasing the time between screenings, interval cancers are given more time to develop and grow, which tend to be more aggressive with worse outcomes.

The Task Force incorrectly lumps women with dense breast tissue into recommendations for average risk women, but women with dense tissue are at a higher-than-average risk. In addition, the Task Force did not consider the combination of risk factors; women with dense breasts and a family history of breast cancer or other risk factors currently meet the criteria for supplemental screening with MRI, in addition to mammography, as stated by the ACS, NCCN and ACR.”

Promoting Compliance to Save Lives

Offering comments on compliance, the statement offered perspective on challenges for women and practitioners moving forward, with this feedback.

"In the United States, compliance with screening guidelines is far less than 100%, whether those of the USPSTF or those of other national organizations. Therefore, a major thrust of the USPSTF recommendation statement should acknowledge this lack of compliance and urge those women and healthcare providers who choose to accept USPSTF recommendations to follow them as presented, specifically not to consider a biennial recommendation as being equivalent to screening every 2½ or 3 years, and not to consider the annual recommendation for those women at ages 40-49 who choose to be screened as being equivalent to screening every 1½ to 2 years."

The ACR/SBI joint statement concluded with these comments:

"We recognize and appreciate that this comment period is designed to receive comments about concerns with the draft guidelines on screening for breast cancer. As there were no breast cancer experts in the guideline development, we hope that those of us who are content experts in this field will shed light, through this document, that some of the conclusions of the USPSTF are incorrect. Please consider our comments seriously as we strongly feel that some of the conclusions and recommendations of the Task Force may negatively impact public health.

Since the biennial screening recommendations are based on the judgment of the panel, we suggest that it be made very clear to women in the United States that the greatest number of lives saved is derived from a strategy of annual screening beginning at age 40 for the average risk woman. Women should be informed that there are risks of not screening or delayed screening which include death. We suggest that the appropriate recommendation should read, 'Since the most lives are saved, women should start annual screening at the age of 40, unless they put a higher value on the potential risks of screening, and that choice should be an individual one (B recommendation).'"

More information: www.acr.org

www.sbi-online.org