title: 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.
abstract: 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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Adjunctive ultrasonography increases sensitivity and detection rate of early cancers.
  
  
  BACKGROUND
  Ministry of Health, Labour and Welfare of Japan.
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan. Electronic address: noriaki-ohuchi@med.tohoku.ac.jp.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Ohuchi
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Suzuki
authors.affiliation: Department of Environmental and Population Sciences, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Tomotaka
authors.initials: T
authors.lastname: Sobue
authors.affiliation: Department of Breast Surgery, Miyagi Cancer Centre Hospital, Miyagi, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawai
authors.affiliation: Department of Screening Assessment and Management, Research Centre for Cancer Prevention and Screening, National Cancer Centre, Tokyo, Japan.
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Ying-Fang
authors.initials: YF
authors.lastname: Zheng
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Yoko Narikawa
authors.initials: YN
authors.lastname: Shiono
authors.affiliation: Department of Screening Assessment and Management, Research Centre for Cancer Prevention and Screening, National Cancer Centre, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.affiliation: Department of Disaster-Related Public Health, International Research Institute of Disaster Science, Tohoku University, Sendai, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Kuriyama
authors.affiliation: Department of Radiology, Tsukuba Health Evaluation Centre, Tsukuba, Japan.
authors.forename: Eriko
authors.initials: E
authors.lastname: Tohno
authors.affiliation: Department of Radiology, Higashi Nagoya National Hospital, Nagoya, Japan.
authors.forename: Tokiko
authors.initials: T
authors.lastname: Endo
authors.affiliation: Department of Public Health, Yamagata University School of Medicine, Yamagata, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Fukao
authors.affiliation: Department of Public Health, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Tsuji
authors.affiliation: Department of Biostatistics, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.affiliation: Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.affiliation: Department of Surgery, St Marianna University Breast and Imaging Centre, Kawasaki, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Fukuda
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Ishida
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000175:diagnosis*; D018270:Carcinoma, Ductal, Breast; D018275:Carcinoma, Lobular; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D007564:Japan; D008327:Mammography; D008875:Middle Aged; D012680:Sensitivity and Specificity; D016217:Ultrasonography, Mammary