Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon 69008, France.
J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.
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.
一项三年度的临床乳房检查（CBE）能否降低侵袭性疾病发生率和乳腺癌死亡率的随机对照试验于 2006 年 1 月 1 日在印度特里凡得琅地区启动，共有 275 个包含 115652 名 30-69 岁健康女性的集群被随机分配到干预组（CBE；133 个集群；55844 名女性）或对照组（无筛查；142 个集群；59808 名女性）。评估了 CBE 的性能特征（敏感性、特异性、假阳性率和阳性预测值）。采用意向治疗分析比较了干预组和对照组的发病率。发病率的初步结果基于截至 2009 年 5 月 31 日的随访，此时第一轮筛查已经完成。在接受 CBE 的 50366 名女性中，30 例乳腺癌在 CBE 筛查中发现，2880 名女性的 CBE 筛查结果可疑，需要进一步检查。CBE 的敏感性、特异性、假阳性率和阳性预测值分别为 51.7%（95%置信区间[CI]：38.2%至 65.0%）、94.3%（95% CI：94.1%至 94.5%）、5.7%（95% CI：5.5%至 5.9%）和 1.0%（95% CI：0.7%至 1.5%）。早期（IIA 期或更低）乳腺癌的年龄标准化发病率分别为每 100000 名妇女 18.8 和 8.1 例，晚期（IIB 期或更高）乳腺癌的发病率分别为每 100000 名妇女 19.6 和 21.7 例，在干预组和对照组中。
