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Lancet. 2016 Jan 23;387(10016):341-348. doi: 10.1016/S0140-6736(15)00774-6. Epub 2015 Nov 5.

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.

Author information

1
Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan. Electronic address: noriaki-ohuchi@med.tohoku.ac.jp.
2
Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
3
Department of Environmental and Population Sciences, Graduate School of Medicine, Osaka University, Osaka, Japan.
4
Department of Breast Surgery, Miyagi Cancer Centre Hospital, Miyagi, Japan.
5
Department of Screening Assessment and Management, Research Centre for Cancer Prevention and Screening, National Cancer Centre, Tokyo, Japan.
6
Department of Disaster-Related Public Health, International Research Institute of Disaster Science, Tohoku University, Sendai, Japan.
7
Department of Radiology, Tsukuba Health Evaluation Centre, Tsukuba, Japan.
8
Department of Radiology, Higashi Nagoya National Hospital, Nagoya, Japan.
9
Department of Public Health, Yamagata University School of Medicine, Yamagata, Japan.
10
Department of Public Health, Graduate School of Medicine, Tohoku University, Sendai, Japan.
11
Department of Biostatistics, Graduate School of Medicine, Tohoku University, Sendai, Japan.
12
Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.
13
Department of Surgery, St Marianna University Breast and Imaging Centre, Kawasaki, Japan.

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.

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.

PMID:
26547101
DOI:
10.1016/S0140-6736(15)00774-6
[Indexed for MEDLINE]

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