Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Sendai, Japan.
Lancet. 2016 Jan 23;387(10016):341-348. doi: 10.1016/S0140-6736(15)00774-6. Epub 2015 Nov 5.
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.
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.
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).
Adjunctive ultrasonography increases sensitivity and detection rate of early cancers.
Ministry of Health, Labour and Welfare of Japan.
乳腺 X 线摄影术是降低乳腺癌死亡率的唯一经证实的方法，但在年轻女性或乳腺致密的女性中并不准确。我们研究了辅助超声检查的效果。
2007 年 7 月至 2011 年 3 月，我们在日本 23 个县的 42 个研究点纳入了 40-49 岁的无症状女性参加日本策略性抗癌随机试验（J-START）。符合条件的女性在过去 5 年内没有癌症病史，预期寿命超过 5 年。参与者通过日本临床研究支持单位进行中央随机分组。参与者按 1:1 的比例随机分为乳腺 X 线摄影术和超声检查（干预组）或仅行乳腺 X 线摄影术（对照组），每 2 年进行 2 次筛查。主要结局为第一轮筛查时的敏感性、特异性、癌症检出率和分期分布。分析采用意向治疗。这项研究已注册，注册号 UMIN000000757。
在纳入的 72998 名女性中，36859 名被分配到干预组，36139 名被分配到对照组。干预组的敏感性明显高于对照组（91.1%，95%CI 87.2-95.0 与 77.0%，70.3-83.7；p=0.0004），而特异性明显较低（87.7%，87.3-88.0 与 91.4%，91.1-91.7；p<0.0001）。干预组的癌症检出率高于对照组（184 [0.50%] 与 117 [0.32%]，p=0.0003），且更多为 0 期和 I 期（144 [71.3%] 与 79 [52.0%]，p=0.0194）。干预组检测到 18 例（0.05%）间隔期癌症，而对照组检测到 35 例（0.10%）（p=0.034）。
辅助超声检查可提高早期癌症的敏感性和检出率。
日本厚生劳动省。
