COMMENT LETTER TO THE U.S. PREVENTIVE SERVICES TASK FORCE ON DRAFT RECOMMENDATION STATEMENT ON BREAST CANCER SCREENING

Albert L. Siu, M.D.. M.S.P.H.
Chairman
United States Preventive Services Task Force
540 Gaither Road
Rockville, MD 20850

Re: Screening for Breast Cancer: Draft U.S. Preventive Services Task Force Recommendations

Dear Chairman Siu:

The Medical Imaging & Technology Alliance (MITA) appreciates the opportunity to submit comments on the United States Preventive Services Task Force (USPSTF) Draft Recommendation Statement on breast cancer screening. As the leading trade association representing medical imaging device manufacturers, MITA has in-depth knowledge of the significant benefits that early and accurate diagnosis through medical imaging provides.

Breast cancer is the most common cancer diagnosed in women, affecting 1 in 8 women in their lifetimes—almost 300,000 women were diagnosed with breast cancer in 2013.[1] Since the introduction of mammography screening, mortality from breast cancer has decreased by 30 percent;[2] however it is still the second most common cause of cancer death in women, killing almost 40,000 in 2013.[3] According to The National Breast Cancer Foundation, 98 percent of breast cancer patients survive—if detection occurs early. To maintain this success, it is of the utmost importance that a woman’s access to breast cancer screening technology remains intact.

Our comments address several critical concerns with the Draft Recommendation Statement: (1) We are very concerned with the scientific methodology used by USPSTF in its analysis of the benefits and harms of breast cancer screening; (2) We strongly encourage USPSTF to take into account all of the data on breast tomosynthesis; (3) We disagree with the recommended biennial interval for screening mammography for women ages 50 to 74 years; (4) We disagree with the C grade for screening mammography for women ages 40 to 49 years; (5) Breast cancer screening is already underutilized; (6) We encourage USPSTF to take into account the position statements and guidelines of the relevant professional societies; (7) We would like to draw attention to the practical implications of these draft screening recommendations on coverage and therefore utilization.

(1) We are very concerned with the scientific methodology used by USPSTF in its analysis of the benefits and harms of breast cancer screening.

We are very concerned with the scientific methodology adopted by the USPSTF, particularly with the uneven rigor in considering the scientific evidence for the benefits of screening mammography versus the harms of screening mammography.

When the benefits of screening were considered, the USPSTF rejected a number of well-executed prospective clinical trials solely on the basis that their design was not randomized. However, when considering the harms of screening, the USPSTF did not adhere to the same scientific standards and provided no credible scientific evidence for its assertion that false positive findings on a mammogram cause measurable, lasting harm to the patient.

Quite to the contrary, a paper published in 2014 in the Journal of the American Medical Association studied the consequences of false-positive screening mammograms and concluded that false-positive mammograms were associated with increased short-term anxiety, but not long-term anxiety, and there was no measurable health utility decrement.[4] The results in this study matched an earlier study from 2000 that concluded that women are aware of false positives and view them as an acceptable consequence of screening mammography.[5]

According to the Draft Recommendation Statement, “The most important harm is the diagnosis and treatment of noninvasive and invasive breast cancer that would otherwise not have become a threat to a woman’s health, or even apparent, during her lifetime (i.e., overdiagnosis and overtreatment).” Like so many positions asserted by the USPSTF without sufficient evidence, the etiology of breast cancer is elusive.[6] Given that little is known about the etiology of cancer, there is a questionable basis that some cancers will never become lethal and a threat to a woman’s health. The USPSTF provides no credible evidence that early detection by screening mammography uncovers indolent cancers that will do no harm to the woman in her lifetime

(2) We strongly encourage USPSTF to take into account all of the data on breast tomosynthesis.

A critical review of the entire body of evidence should conclude that there is a high level of confidence that traditional mammography combined with breast tomosynthesis is superior to traditional mammography in two key performance characteristics: the detection of breast cancer and the reduction of recalls and false positives.

More than 250 publications have evaluated the performance of breast tomosynthesis and results are clear, consistent, and undeniable: breast tomosynthesis is an effective screening modality for the early and accurate detection of breast cancer.[7], [8] 

Large-scale, peer-reviewed clinical research shows that breast cancer screening with breast tomosynthesis finds up to 40 percent more invasive cancers than conventional 2D mammography.[9] Additionally, breast tomosynthesis increases diagnostic accuracy and reduces unnecessary callbacks up to 40 percent. [10]

These findings were recently validated in a study published in the Journal of the American Medical Association (JAMA), the largest study to date with a total of 454,850 examinations (281,187 conventional mammograms compared to 173,663 3D mammography exams). The results confirmed that breast tomosynthesis finds significantly more invasive cancers than a traditional mammogram – an improvement of 41 percent. [11] The researchers also found that 3D mammography reduces the number of women called back for unnecessary testing due to false positives by 15 percent.

Based on the JAMA study in addition to three other large studies, breast tomosynthesis is superior to traditional digital mammography (DM) with respect to two performance characteristics important to breast cancer experts: 1) the detection of invasive breast cancer and 2) the reduction of false-positive mammograms. These benefits are documented in the following tables, which summarize several key studies.

 
Exams
Follow-up
Recall/false positive rate: DM+BT
Recall/false positive rate:
DM
Alone
% Reduction in recall/false positive rate
P-value
Friedewald
454,850
NR
9.1%
10.7%
15%
<0.001
Skaane
12,631
Limited
5.3%*
6.1%*
15%*
<0.001
Ciatto
7,292
13 months
4.3%*
5.0%*
17%*
<0.01
Rose
10,878
NR
5.5%
8.7%
37%
<0.001

 

*False positive rates for the Skaane 2013 and Ciatto 2013 were estimated based on the % of cases recommended for arbitration by a single reader

Overall
Cancer Detection:
DM+BT
(Cancers/ 1000)
Overall
Cancer Detection:
DM alone
(Cancers/ 1000)
%
Change With BT
P-value
Invasive
Cancer Detection:
DM+BT
(Cancers/ 1000)
Invasive Cancer Detection:
DM alone
(Cancers/ 1000)
%
Change With BT
P-value
Friedewald
5.4
4.2
+29%
<0.001
4.1
2.9
+41%
<0.001
Skaane
8.0
6.1
+31%
0.001
6.4
4.4
+45%
<0.001
Ciatto
8.1
5.3
+53%
<0.0001
7.1
4.8
+48%
NR
Rose
5.4
3.5
+54%
<0.0001
4.4*
2.7*
+66%
<0.0001

*Imputed from reported data

Further evidence demonstrates that breast tomosynthesis is effective for all age groups in reducing the recall rate. In the Rose study, while the average reduction in false positive results is 37 percent, all age populations realized an improvement in the recall rate as follows:

< 50 years old 37.2 percent

50-64 years old 32.9 percent

> 65 years old 46.6 percent

In addition, USPSTF should have taken into consideration the recent Final Findings and Decision issued by the Washington State Health Care Authority wherein digital breast tomosynthesis was determined to be a “covered benefit supplementary to digital mammography in woman aged 40 to 74 who are candidates for screening mammography.”[12]

We would also like to draw attention to the fact that, beginning in 2015, Medicare began to pay for screening tomosynthesis.

(3) We disagree with the recommended biennial interval for screening mammography for women ages 50 to 74 years.

Breast cancer accounts for 40,000 deaths every year in the United States and has a devastatingly low survival rate when not detected early. Annual screening mammograms allow for tumors to be detected earlier when they are more treatable. Shifting screening recommendations to biennial from annual will lead to later detection of tumors thereby resulting in greater intensity of intervention and loss of life.

(4) We disagree with the C grade for screening mammography for women ages 40 to 49 years.

Early and accurate detection of tumors is the most effective way to extend and improve the lives of women with breast cancer. By shifting the age of initial mammogram from 40 to 50 years, many tumors will go undetected until they have increased in size, metastasized, or become symptomatic. This will lead to more lives lost and lower quality of life due to more intense treatment for women whose tumors are detected later. Published studies indicate that the sojourn time—the interval between when a cancer is detectable with screening mammography to the point at which it is clinically detectable—is approximately 2.4 years for women with a mean age between 40-49 years of age.

Further, given that the majority of women ages 40 to 49 years have at least one risk factor associated with a greater chance of developing breast cancer, MITA urges the USPSTF to recommend that all women in this age group receive annual screening mammograms.

(5) Breast cancer screening is already underutilized.

On May 8, 2015, the Centers for Disease Control and Prevention (CDC) published a report in which it examined utilization of breast, cervical, and colon cancer screening services.[13] In this report, CDC finds that mammography is still an underutilized cancer screening service based on the cancer screening goals established by HHS in 2010. In 2013, 72.6% of women reported receiving a mammogram in the last two years. This is well below the goal of 81.1% for the year 2020. Even more worrisome is the fact that this is below the 2008 baseline of 73.7%.

It is our concern that, if finalized, these breast cancer screening guidelines would further drive down utilization of mammography, thereby putting more women at risk of breast cancer. Further, we are very concerned with the mixed messages that the government sends to women when one agency recommends restrictive screening practices while another agency is critical of underutilization.

(6) We encourage USPSTF to take into account the position statements and guidelines of the relevant professional societies. 

A number of physicians may provide comprehensive care to a patient along the breast cancer treatment pathway: the primary care provider, the referring physician—who is often an OB/GYN, the radiologist, the surgeon, among others. In all cases, the professional societies representing these providers disagree with the draft recommendations. The American Medical Association (AMA) continues to recommend annual screening mammograms for women starting at age 40.[14] The American College of Obstetricians and Gynecologists (ACOG) continues to recommend annual screening mammograms for women starting at age 40.[15] The American College of Radiology (ACR) continues to recommend annual screening mammograms for women starting at age 40 and claims that thousands of lives will be lost if the draft recommendations are finalized.[16] The American Society of Breast Surgeons continues to recommend annual screening mammograms for women starting at age 40.[17]

MITA would like to express concern that radiologists and surgical oncologists are not represented on the USPSTF. For this reason, MITA encourages increased diversity in medical specialty representation on the USPSTF when developing a research plan, analyzing evidence, and preparing final recommendations to account for the level of diversity that reflects actual clinical practice.

(7) We would like to draw attention to the practical implications of these draft screening recommendations on coverage and therefore utilization.

The Patient Protection and Affordable Care Act (ACA) requires that private insurers pay for preventive services with an A or B grade without cost-sharing from the beneficiary. If the draft breast cancer screening recommendations are finalized, private insurers will have the option to only provide screening mammography without cost-sharing biennially to women ages 50 to 74 years. This will create a cost barrier for numerous women who cannot afford to pay for mammograms out of pocket, and, consequently, will further diminish screening compliance leading to a higher incidence of breast cancer.

*       *       *       *

MITA appreciates this opportunity to comment on the Draft Breast Cancer Screening Recommendations. We would be pleased to answer any questions you might have about these comments.  Please contact me at (703) 841-3238 if MITA can be of any assistance.

Sincerely,
Peter M. Weems
Director of Policy, MITA

[1] American Cancer Society. Cancer Facts and Figures 2013-2014 http://www.cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index

[2] Tabar L, Vitak B, Chen HH, et al. The Swedish Two-County Trial twenty years later. Updated mortality results and new insights from longterm follow-up. Radiol Clin North Am. Jul 2000;38(4):625-651.

[3] American Cancer Society. Cancer Facts and Figures 2013-2014 http://www.cancer.org/research/cancerfactsstatistics/allcancerfactsfigures/index

[4] Anna N. A. Tosteson; Dennis G. Fryback; Cristina S. Hammond; Lucy G. Hanna; Margaret R. Grove; Mary Brown; QianfeiWang; Karen Lindfors; Etta D. Pisano, “Consequences of False-Positive Screening Mammograms” JAMA Internal Medicine, 2014; 174 (6): 954

[5] Lisa M Schwartz, Steven Woloshin, Harold C Sox, Baruch Fischhoff, H Gilbert Welch “US women’s attitudes to false positive mammography results and detection of ductal carcinoma in situ: cross sectional survey” BMJ VOLUME 320 17 JUNE 2000 bmj.com

[6] Jay R. Harris, Marc Lippman, Monica Morrow, C. Kent Osbourne, “Diseases of the Breast” 5th edition. ISBN/ISSN 9781451186277

[7] Ciatto S, Houssami N, Bernardi D, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. The lancet oncology. 2013;14(7):583-589.

[8] Houssami N, Macaskill P, Bernardi D, et al. Breast screening using 2D-mammography or integrating digital breast tomosynthesis (3D-mammography) for single-reading or double-reading–Evidence to guide future screening strategies. European Journal of Cancer. 2014;50(10):1799-1807.

[9] Skaane P, Bandos AI, Gullien R, et al. Comparison of Digital Mammography Alone and Digital Mammography Plus Tomosynthesis in a Population-based Screening Program. Radiology.2013;267(1):47-56.

[10] Rose SL, Tidwell AL, Ice MF, Nordmann AS, Sexton R, Song R. A Reader Study Comparing Prospective Tomosynthesis Interpretations with Retrospective Readings of the Corresponding FFDM Examinations. Academic Radiology. 2014;21(9):1204-1210.

[11] Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014;311(24):2499-2507.

[12] http://www.hca.wa.gov/hta/Documents/breast_imaging_final_findings_decision_033015.pdf

[13] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6417a4.htm?s_cid=mm6417a4_w

[14] http://www.ama-assn.org/ama/pub/news/news/2012-06-19-ama-adopts-new-policies.page

[15] http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/ACOG-Practice-Advisory-on-Breast-Cancer-Screening

[16] http://www.acr.org/About-Us/Media-Center/Press-Releases/2015-Press-Releases/20150420-Draft-USPSTF-Breast-Cancer-Screening-Recommendations-Would-Cost-Thousands-of-Lives

[17] https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Screening
Mammography.pdf