加拿大国家乳腺筛查研究-2：针对50至59岁女性的一项随机试验的13年结果。
Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years.
作者信息
Miller A B, To T, Baines C J, Wall C
机构信息
Department of Public Health Sciences, University of Toronto, Canada.
出版信息
J Natl Cancer Inst. 2000 Sep 20;92(18):1490-9. doi: 10.1093/jnci/92.18.1490.
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 39 405 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.
背景
对50岁及以上女性进行乳房X线摄影筛查已被证明可降低乳腺癌死亡率。然而，乳房X线摄影在同时接受乳房体格检查的女性中对降低死亡率的贡献程度尚不清楚。本研究旨在比较由双视角乳房X线摄影和乳房体格检查组成的年度筛查后的乳腺癌死亡率与仅通过乳房体格检查进行年度筛查后的死亡率。所有参与者均接受了乳房自我检查的培训。
方法
该试验将1980年1月至1985年3月招募的39405名50 - 59岁女性随机且单独地分配到其中一个研究组。通过与加拿大国家癌症登记处和国家死亡率数据库进行记录链接，对这些女性进行随访至1993年12月31日，并对乳腺癌患者进行积极随访至1996年6月30日。
结果
随机分组实现了人口统计学和乳腺癌风险变量的几乎均等分布。在首次年度筛查时，仅通过乳房X线摄影发现的癌症（在乳房X线摄影加体格检查组中）有21%的大小为20毫米或更大，而在乳房X线摄影加体格检查组中通过体格检查发现的癌症为46%，在仅体格检查组中为56%。第2 - 5次筛查的相应百分比分别为10%、42%和50%。乳房X线摄影加体格检查组筛查出267例浸润性乳腺癌，而仅体格检查组为148例。到1993年12月31日，乳房X线摄影加体格检查组确定了622例浸润性和71例原位乳腺癌，仅体格检查组确定了610例和16例。在13年的随访中，两组分别有107例和105例死于乳腺癌，累积率比为1.02（95%置信区间 = 0.78 - 1.33）。
结论
在50 - 59岁女性中，在体格检查基础上增加年度乳房X线摄影筛查对乳腺癌死亡率没有影响。
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