日本医学放射線学会・日本放射線技術学会編：マンモグラフィガイドライン第3版 増補版、医学書院、2014.
「乳がん検診における乳房の構成（高濃度乳房を含む）の 適切な情報提供に資する研究」班：高濃度乳房について 健発0524第1号別添 平成29年度.
Akihiko Suzuki, Shinichi Kuriyama, Masaaki Kawai, Masakazu Amari, Motohiro Takeda, Takanori Ishida, Koji Ohnuki, Yoshikazu Nishino, Ichiro Tsuji, Daisuke Shibuya, Noriaki Ohuchi
Age-specific interval breast cancers in Japan: estimation of the proper sensitivity of screening using a population-based cancer registry.
Cancer Sci. 2008 Nov;99(11):2264-7. doi: 10.1111/j.1349-7006.2008.00926.x. Epub 2008 Sep 15.
Abstract/Text
The age-specific sensitivity of a screening program was investigated using a population-based cancer registry as a source of false-negative cancer cases. A population-based screening program for breast cancer was run using either clinical breast examinations (CBE) alone or mammography combined with CBE in the Miyagi Prefecture from 1997 to 2002. Interval cancers were newly identified by linking the screening records to the population-based cancer registry to estimate the number of false-negative cases of screening program. Among 112 071 women screened by mammography combined with CBE, the number of detected cancers, false-negative cases and the sensitivity were 289, 22 and 92.9%, respectively, based on the reports from participating municipalities. The number of newly found false-negative cases and corrected sensitivity when using the registry were 34 and 83.8%, respectively. In detected cancers, the sensitivity of screening by mammography combined with CBE in women ranging from 40 to 49 years of age based on a population-based cancer registry was much lower than that in women 50-59 and 60-69 years of age (40-49: 18, 71.4%, 50-59: 19, 85.8%, 60-69: 19, 87.2%). These data suggest that the accurate outcome of an evaluation of breast cancer screening must include the use of a population-based cancer registry for detecting false-negative cases. Screening by mammography combined with CBE may therefore not be sufficiently sensitive for women ranging from 40 to 49 years of age.
US Preventive Services Task Force
Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement.
Ann Intern Med. 2009 Nov 17;151(10):716-26, W-236. doi: 10.7326/0003-4819-151-10-200911170-00008.
Abstract/Text
DESCRIPTION: Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for breast cancer in the general population.
METHODS: The USPSTF examined the evidence on the efficacy of 5 screening modalities in reducing mortality from breast cancer: film mammography, clinical breast examination, breast self-examination, digital mammography, and magnetic resonance imaging in order to update the 2002 recommendation. To accomplish this update, the USPSTF commissioned 2 studies: 1) a targeted systematic evidence review of 6 selected questions relating to benefits and harms of screening, and 2) a decision analysis that used population modeling techniques to compare the expected health outcomes and resource requirements of starting and ending mammography screening at different ages and using annual versus biennial screening intervals.
RECOMMENDATIONS: The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient's values regarding specific benefits and harms. (Grade C recommendation) The USPSTF recommends biennial screening mammography for women between the ages of 50 and 74 years. (Grade B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination beyond screening mammography in women 40 years or older. (I statement) The USPSTF recommends against clinicians teaching women how to perform breast self-examination. (Grade D recommendation) The USPSTF concludes that the current evidence is insufficient to assess additional benefits and harms of either digital mammography or magnetic resonance imaging instead of film mammography as screening modalities for breast cancer. (I statement).
厚生労働省健康局：がん予防重点健康教育及びがん検診実施のための指針 健発第0331058号別添 令和3年度一部改正.
H G Welch, W C Black
Using autopsy series to estimate the disease "reservoir" for ductal carcinoma in situ of the breast: how much more breast cancer can we find?
Ann Intern Med. 1997 Dec 1;127(11):1023-8.
Abstract/Text
PURPOSE: To determine how many cases of breast cancer might be found if women not known to have the disease were thoroughly examined (the disease "reservoir").
DATA SOURCES: MEDLINE search from 1966 to the present.
STUDY SELECTION: Hospital-based and forensic autopsy series examining women not known to have had breast cancer during life.
DATA EXTRACTION: Observed prevalence of occult invasive breast cancer or ductal carcinoma in situ (DCIS) in which the number of women who were given a diagnosis was the numerator and the number of women examined was the denominator. For each autopsy series, we attempted to ascertain the level of scrutiny (sampling method, number of slides examined) given to the pathologic specimens.
DATA SYNTHESIS: Among seven autopsy series of women not known to have had breast cancer during life, the median prevalence of invasive breast cancer was 1.3% (range, 0% to 1.8%) and the median prevalence of DCIS was 8.9% (range, 0% to 14.7%). Prevalences were higher among women likely to have been screened (that is, women 40 to 70 years of age). The mean number of slides examined per breast ranged from 9 to 275; series that reported higher levels of scrutiny tended to discover more cases of cancer.
CONCLUSIONS: A substantial reservoir of DCIS is undetected during life. How hard pathologists look for the disease and, perhaps, their threshold for making the diagnosis are potentially important factors in determining how many cases of DCIS are diagnosed. The latter has important implications for what it means to have the disease.
Sue Moss
Overdiagnosis and overtreatment of breast cancer: overdiagnosis in randomised controlled trials of breast cancer screening.
Breast Cancer Res. 2005;7(5):230-4. doi: 10.1186/bcr1314. Epub 2005 Aug 25.
Abstract/Text
Data from randomised controlled trials of mammographic screening can be used to determine the extent of any overdiagnosis, as soon as either a time equivalent to the lead-time has elapsed after the final screen, or the control arm has been offered screening. This paper reviews those randomised trials for which breast cancer incidence data are available. In recent trials in which the control group has not been offered screening, an excess incidence of breast cancer remains after many years of follow-up. In those trials in which the control arm has been offered screening, although there is a possible shift from invasive to in situ disease, there is no evidence of overdiagnosis as a result of incident screens.
The benefits and harms of breast cancer screening: an independent review - PubMed [Internet]. [cited 2022 Feb 15]. Available from: https://pubmed.ncbi.nlm.nih.gov/23117178/
Paola Pisani, D M Parkin, Corazon Ngelangel, Divina Esteban, Lorna Gibson, Marilou Munson, Mary Grace Reyes, Adriano Laudico
Outcome of screening by clinical examination of the breast in a trial in the Philippines.
Int J Cancer. 2006 Jan 1;118(1):149-54. doi: 10.1002/ijc.21343.
Abstract/Text
The value of screening by Clinical Examination of the Breast (CBE) as a means of reducing mortality from breast cancer (BC) is not established. The issue is relevant, as CBE may be a suitable option for countries in economic transition, where incidence rates are on the increase but limited resources do not permit screening by mammography. Our aims were to assess whether mass screening by CBE carried out by trained para-medical personnel is feasible in an urban population of a low-income country, and its efficacy in reducing BC mortality. Our study was designed as a randomised controlled trial of the effect on BC mortality of 5 annual CBE carried out by trained nurses. The target population was women aged 35-64 years, resident in 12 municipalities of the National Capital Region of Manila, Philippines. The units of randomization were the 202 health centres (HC) within the selected municipalities. During 1995 nurses and midwives were recruited and trained in performing CBE. The first round of screening took place in 1996-1997. The intervention however showed a refractory attitude of the population with respect to clinical follow-up and was discontinued after the completion of the first screening round. Cases of breast cancer occurring in the study population during 1996-1999 were identified by the 2 local population-based registries. In the single screening round 151,168 women were interviewed and offered CBE, 92% accepted (138,392), 3,479 were detected positive for a lump and referred for diagnosis. Of these only 1220 women (35%) completed diagnostic follow-up, whereas 42.4% actively refused further investigation even with home visits, and 22.5% were not traced. Of 53 cases that occurred among screen-positive women in the 2 years after CBE only 34 were diagnosed through the intervention. Eighty cases occurred among screen-negative women. The test sensitivity for CBE repeated annually was 53.2%. The actual sensitivity of the programme was 25.6% and positive predictive value 1%. Screen-detected cases were non-significantly less advanced than the others. Previous studies have shown that most breast cancer cases in the Philippines present at advanced stages and have an unfavourable outcome. Although CBE undertaken by health workers seems to offer a cost-effective approach to reducing mortality, the sensitivity of the screening programme in the real context was low. Moreover, in this relatively well-educated population, cultural and logistic barriers to seeking diagnosis and treatment persist and need to be addressed before any screening programme is introduced.
Copyright 2005 Wiley-Liss, Inc.
Rengaswamy Sankaranarayanan, Kunnambath Ramadas, Somanathan Thara, Richard Muwonge, Jem Prabhakar, Paul Augustine, Muraleedharan Venugopal, Gopan Anju, Beela Sara Mathew
Clinical breast examination: preliminary results from a cluster randomized controlled trial in India.
J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.
Abstract/Text
A cluster randomized controlled trial was initiated in the Trivandrum district (Kerala, India) on January 1, 2006, to evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced disease incidence and breast cancer mortality. A total of 275 clusters that included 115,652 healthy women, aged 30-69 years, were randomly allocated to intervention (CBE; 133 clusters; 55,844 women) or control (no screening; 142 clusters; 59,808 women) groups. Performance characteristics (sensitivity, specificity, false-positive rate, and positive predictive value) of CBE were evaluated. An intention-to-treat analysis was performed for comparison of incidence rates between the intervention and control groups. Preliminary results for incidence are based on follow-up until May 31, 2009, when the first round of screening was completed. Of the 50,366 women who underwent CBE, 30 breast cancers were detected among 2880 women with suspicious findings in CBE screening that warranted further investigations. Sensitivity, specificity, false-positive rate, and positive predictive value of CBE were 51.7% (95% confidence interval [CI] = 38.2% to 65.0%), 94.3% (95% CI = 94.1% to 94.5%), 5.7% (95% CI = 5.5% to 5.9%), and 1.0% (95% CI = 0.7% to 1.5%), respectively. The age-standardized incidence rates for early-stage (stage IIA or lower) breast cancer were 18.8 and 8.1 per 100,000 women and for advanced-stage (stage IIB or higher) breast cancer were 19.6 and 21.7 per 100,000 women, in the intervention and control groups, respectively.
S Kanemura, I Tsuji, N Ohuchi, H Takei, T Yokoe, Y Koibuchi, K Ohnuki, A Fukao, S Satomi, S Hisamichi
A case control study on the effectiveness of breast cancer screening by clinical breast examination in Japan.
Jpn J Cancer Res. 1999 Jun;90(6):607-13.
Abstract/Text
A case-control study was conducted in Miyagi and Gunma prefectures, Japan, to evaluate the effectiveness of breast cancer screening by clinical breast examination (CBE) alone in reducing breast cancer mortality. Case subjects, who were female and had died of breast cancer, were collected from residential registry files and medical records. Control subjects matched in sex, age and residence were randomly selected from residential registry files. The screening histories during 5 years prior to the cases having been diagnosed as breast cancer were surveyed using the examinee files of the screening facilities. Finally, the data of 93 cases and 375 controls were analyzed. The odds ratio (OR) of breast cancer death for participating in screening at least once during 5 years was 0.93 (95% confidence interval (95% CI) 0.48-1.79). The cases were more symptomatic than the controls when screened. If the participants who had had symptoms in their breasts were classified as not screened, the OR decreased to 0.56 (95% CI 0.27-1.18). The case control study suggests that the current screening modality (CBE) lacks effectiveness (OR = 0.93), although it might be effective for an asymptomatic population (OR = 0.56). The number of cases was small, and a larger case-control study is desirable to define whether CBE is effective or not. However, it is necessary to consider the introduction of mammographic screening to reduce breast cancer mortality in Japan.
Noriaki Ohuchi, Akihiko Suzuki, Tomotaka Sobue, Masaaki Kawai, Seiichiro Yamamoto, Ying-Fang Zheng, Yoko Narikawa Shiono, Hiroshi Saito, Shinichi Kuriyama, Eriko Tohno, Tokiko Endo, Akira Fukao, Ichiro Tsuji, Takuhiro Yamaguchi, Yasuo Ohashi, Mamoru Fukuda, Takanori Ishida, J-START investigator groups
Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial.
Lancet. 2016 Jan 23;387(10016):341-8. doi: 10.1016/S0140-6736(15)00774-6. Epub 2015 Nov 5.
Abstract/Text
BACKGROUND: Mammography is the only proven method for breast cancer screening that reduces mortality, although it is inaccurate in young women or women with dense breasts. We investigated the efficacy of adjunctive ultrasonography.
METHODS: Between July, 2007, and March, 2011, we enrolled asymptomatic women aged 40-49 years at 42 study sites in 23 prefectures into the Japan Strategic Anti-cancer Randomized Trial (J-START). Eligible women had no history of any cancer in the previous 5 years and were expected to live for more than 5 years. Randomisation was done centrally by the Japan Clinical Research Support Unit. Participants were randomly assigned in 1:1 ratio to undergo mammography and ultrasonography (intervention group) or mammography alone (control group) twice in 2 years. The primary outcome was sensitivity, specificity, cancer detection rate, and stage distribution at the first round of screening. Analysis was by intention to treat. This study is registered, number UMIN000000757.
FINDINGS: Of 72,998 women enrolled, 36,859 were assigned to the intervention group and 36,139 to the control group. Sensitivity was significantly higher in the intervention group than in the control group (91·1%, 95% CI 87·2-95·0 vs 77·0%, 70·3-83·7; p=0·0004), whereas specificity was significantly lower (87·7%, 87·3-88·0 vs 91·4%, 91·1-91·7; p<0·0001). More cancers were detected in the intervention group than in the control group (184 [0·50%] vs 117 [0·32%], p=0·0003) and were more frequently stage 0 and I (144 [71·3%] vs 79 [52·0%], p=0·0194). 18 (0·05%) interval cancers were detected in the intervention group compared with 35 (0·10%) in the control group (p=0·034).
INTERPRETATION: Adjunctive ultrasonography increases sensitivity and detection rate of early cancers.
FUNDING: Ministry of Health, Labour and Welfare of Japan.
Copyright © 2016 Elsevier Ltd. All rights reserved.
Overall assessment system of combined mammography and ultrasound for breast cancer screening in Japan - PubMed [Internet]. [cited 2022 Feb 15]. Available from: https://pubmed.ncbi.nlm.nih.gov/33389614/
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植松孝悦、笠原善郎、鈴木明彦、他：ブレスト・アウェアネス―乳房の健康教育、日乳癌検診学会誌、2020；29（1）：27-33.
Worldwide Review and Meta-Analysis of Cohort Studies Measuring the Effect of Mammography Screening Programmes on Incidence-Based Breast Cancer Mortality - PubMed [Internet]. [cited 2022 Feb 15]. Available from: https://pubmed.ncbi.nlm.nih.gov/32326646/
