Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years
Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years
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DOI：
10.1093/jnci/92.18.1490
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发表时间：
2000-09-20
影响因子：
10.3
通讯作者：
Wall, C
中科院分区：
文献类型：
--
作者：
Miller, AB;To, T;Wall, C
背景：在50岁或50岁以上的女性中，通过乳房X光检查筛查乳腺癌已被证明可以降低乳腺癌的死亡率。然而，乳房X光检查在多大程度上有助于降低同时接受乳房体检的女性的死亡率尚不清楚。这项研究旨在比较每年进行乳房X光检查和体格检查后的乳腺癌死亡率与仅通过体检进行年度筛查后的死亡率。所有参与者都接受了乳房自我检查的培训。方法：本试验随机、个别地将1980-01-1985-03招募的39405名年龄在50-59岁的女性分配到一支研究队伍中。到1993年12月31日，对这些妇女进行了与加拿大国家癌症登记和国家死亡率数据库的记录联系，并对乳腺癌患者进行了积极的跟踪调查，直到1996年6月30日。结果：随机化实现了人口统计学和乳腺癌风险变量的几乎均匀分布。在第一次年度筛查中，仅通过乳房X光检查(乳房X光检查加体检组)发现的癌症中有21%的大小在20毫米或更大，相比之下，在乳房X光检查加体检组和仅体检组中，体检发现的癌症分别为46%和56%。屏幕2-5的相应百分比分别为10%、42%和50%。筛查发现浸润性乳腺癌267例，乳房X光检查加体检组为148例，体检组为148例。至1993年12月31日，钼靶摄影加体检组确诊浸润性乳腺癌622例，原位乳腺癌71例，单纯体检组确诊乳腺癌610例，原位乳腺癌16例。在13年的随访中，分别有107人和105人死于乳腺癌，累积比率为1.02(95%可信区间=0.78-1.33)。结论：在50-59岁的女性中，在体检中增加每年一次的乳房X光检查对乳腺癌死亡率没有影响。
Background: Screening for breast cancer with mammography in women aged 50 years or more has been shown to reduce mortality from breast cancer. However, the extent to which mammography contributes to the reduction of mortality in women who also undergo physical examination of the breasts is not known. This study was designed to compare breast cancer mortality following annual screening consisting of two-view mammography and physical examination of the breasts with mortality following annual screening by physical examination only. Breast self-examination was taught to all participants. Methods: This trial randomly and individually assigned 39405 women aged 50-59 years, recruited from January 1980 through March 1985, to one of the study arms. The women were followed by record linkage with the Canadian National Cancer Registry and National Mortality Database to December 31, 1993, and by active follow-up of breast cancer patients to June 30, 1996, Results: Randomization achieved virtually equal distribution of demographic and breast cancer risk variables. At the first annual screen, 21% of the cancers found by mammography alone (in the mammography plus physical examination group) were 20 mm or more in size compared with 46% of those found by physical examination in the mammography plus physical examination group and 56% in the physical examination-only group. The corresponding percentages for screens 2-5 were 10%, 42%, and 50%, respectively. Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group. By December 31, 1993, 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group, and 610 and 16 were ascertained in the physical examination-only group. At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups, the cumulative rate ratio was 1.02 (95% confidence interval = 0.78-1.33). Conclusion: In women aged 50-59 years, the addition of annual mammography screening to physical examination has no impact on breast cancer mortality.