Improvement of Accuracy of Breast Cancer Screening

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Emma Ellis
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1 27 Improvement of Accuracy of Breast Cancer Screening Current Situation The morbidity of female breast cancer by age starts to increase from the 30s, peaks from the late 40s to 60s, then gradually decreases. Morbidity and mortality of female breast cancer has consistently been increasing year by year and statistics show that an estimated 13,400 patients died and an estimated 86,700 patients (one in 12 people) suffered from this disease in Japan in However, the rate of breast cancer screening is 80.4 percent in the United States and 74.1 percent in South Korea, but only 36.4 percent in Japan, a rate markedly lower than in other developed countries. 1,2 In the United States, an advanced country in terms of breast cancer screening, patient advocacy groups have suggested that regular mammography screening cannot detect cancer in some cases because of dense breast tissue, leading to the risk of failing to detect a tumor until after it has progressed. This has now become a social problem. Since 2009, 21 states have had enacted Breast Density Notification Laws aimed at informing mammography examinees that there is a limit on the cancer detection rate in women with highly dense breast tissue. Patients are also told that ultrasonography, digital breast tomosynthesis, and magnetic resonance imaging (MRI) are available as testing alternatives to mammography. In Europe, a study (ASSURE: Adapting Breast Cancer Screening Strategy Using Personalized Risk Estimation) to assess the appropriate breast cancer screening method according to stratification based on individual risks of breast cancer and breast density has been in place since In this study, breast density is measured not visually, but using 3-D measurement software, which provides good reproducibility. In response to these trends in the United States and Europe, women receiving mammography screening inquire about breast density more frequently, and this could also be the case in Japan. Thereby, a multi-center study to verify the efficacy of the use of 3-D breast density measurement software is required for developing an individualized screening program in the future. 3,4,5 In Japan, a large percentage of women in their 40s, the peak age for breast cancer, have dense breast tissue. In response to this, the proportion of local governments using ultrasonography for their screening programs is high, at 31.5 percent (547 of 1735 local governments). However, there is no scientific evidence demonstrating that breast ultrasonography screening decreases mortality. In 2006, the first worldwide RCT, A Randomized Controlled Trial to Verify the Efficacy of the Use of Ultrasonography in Breast Cancer Screening Aged (J-START: Japan Strategic Anti-Cancer Randomized Trial) was conducted with a grant for the third term Comprehensive Control Research for Cancer, by the Ministry of Health, Labour and Welfare of Japan. Approximately 76,000 subjects were enrolled in this study. The results are anticipated to be published soon in a scientific journal. If the scientific efficacy of breast ultrasonography screening for women in their 40s is proven the MHLW Council for Cancer Screenings will discuss whether to include this procedure in the Guideline for Conducting Cancer Prevention Priority Health Education and Cancer Screenings. The Japan Central Organization on Quality Assurance of Breast Cancer Screening began to develop a quality assurance system for ultrasonography screening since 2013, with an eye to the future. As of the end of December 2014, 17,750 doctors and 18,097 technologists have participated in the mammography training program, whereas only 2,082 (vs MMG: 12 percent) doctors and 2,894 technologists (vs MMG: 16 percent) had participated in the ultrasonography training program. Thus, there is an urgent need to carry out actions to drive human resource development, so as to fully 126 Lengthening Healthy Lifespans to Boost Economic Growth

2 introduce breast ultrasonography screening. 2,6,7,8,9 The Japanese Association of Breast Cancer Screening developed Guidelines for the Use of Breast Magnetic Resonance Imaging (MRI) for Breast Cancer Screening in High Risk Women in 2012 to reduce deaths from breast cancer among these women. This is now leading to a gradual increase in the number of institutions conducting MRI screening as an optional examination. Some health insurance societies have also started to provide funding for MRI screening. Guidelines in Europe and the U.S. state that MRIs should not be performed at institutions where MRI-guided biopsies cannot be performed, because MRI breast cancer screening requires a biopsy when lesions of the mammary glands can only be detected by MRI alone. However, in Japan, MR-guided biopsy has not gained popularity because it is not covered by insurance. MR-guided biopsy is available in only 18 institutions across the country. 10,11,12,13,14 In the United States, the Centers for Medicare & Medicaid Services established national average payment rates for digital breast tomosynthesis (DBT) that went into effect January 1, 2015 because the breast cancer detection rate of DBT is higher than that of conventional digital mammography. In Japan as well, institutions which recognize its clinical accuracy and are considering its introduction for the purpose of accurate diagnosis have been increasing. However, DBT has not become widely used because it is more expensive than conventional digital mammography. 15 It has also distributed a free coupon to women 40, 45, 50, 55, and 60 years of age. The government also distributed a coupon to persons who have not had breast cancer screening led by the Cancer Screening Promotion Project and encouraged them to have it (since 2009) done. The Japanese government has funded computer-assisted diagnosis (CAD) to improve the accuracy of mammography screening (since 2007). Recommendations Continue to distribute coupons and to provide financial support encouraging women to have breast cancer screening. Provide funding for human resource development projects to enhance the quality assurance of breast ultrasonography screening with a view to fully introducing it. Provide funding for research projects on the appropriate breast cancer screening methodology according to stratification based on breast density, using 3-D breast density measurement software. Provide funding for introduction of the MRguided biopsy device to assure the accuracy of MRI breast cancer screening. Add a technical fee for reimbursement for digital breast tomosynthesis and breast MRI for the purpose of improving diagnostic accuracy. Current Policy Based on the Basic Plan to Promote Cancer Control Programs, the Japanese government has set a national goal of raising the proportion of women who have had breast cancer screening in the past two years among those 40s or older up to 50 percent. Lengthening Healthy Lifespans to Boost Economic Growth 127

3 References 1. Cancer statistics prediction 2014 Cancer Information Service (in Japanese) 2. The 10th meeting of the Council on Efficient Conduct of Cancer Screening, dated November 13th, 2014: Cancer Screening Document 1 Current status of Breast Cancer Screening (in Japanese) 3. Are you dense 4. Michigan 21st state to enact breast density notification law 5. ASSURE: Adapting Breast Cancer Screening Strategy Using Personalised Risk Estimation 6. J-START (in Japanese) 7. The 88th Council of Health Sciences, Science Technology Working Group, dated December 12, 2014: Document 3-2 Strategic Research Tracking Evaluation Report Strategic research against cancer: A Randomized Controlled Trial to Verify the Efficacy of the Use of Ultrasonography in Breast Cancer Screening (in Japanese) 8. The 11th meeting of the Council on Efficient Conduct of Cancer Screening, dated February 5, 2015: Document 1 The Role of the Japan Central Organization on Quality Assurance of Breast Cancer Screening in the Precision Control of Breast Cancer Screening (in Japanese) 9. The Japan Central Organization on Quality Assurance of Breast Cancer Screening (in Japanese) or.jp/ 10. Guideline of Breast MRI Screening for high risk group of breast cancer (in Japanese) Promotion of awareness for breast cancer screening and extend subsidies for Breast MRI screening for female employees and spouses in Terumo Corporation (in Japanese) American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography onlinelibrary.wiley.com/doi/ /canjclin /full 13. Breast MRI guidelines from the European society of breast imaging Breast Imaging Research and Diagnostic Support Group (in Japanese) DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8874.pdf 128 Lengthening Healthy Lifespans to Boost Economic Growth

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