N Engl J Med. 1995 Nov 30;333(22):1444-55. doi: 10.1056/NEJM199511303332202.
Randomized trials of radiotherapy and surgery for early breast cancer may have been too small to detect differences in long-term survival and recurrence reliably. We therefore performed a systematic overview (meta-analysis) of the results of such trials.
Information was sought on each subject from investigators who conducted trials that began before 1985 and that compared local therapies for early breast cancer. Data on mortality were available from 36 trials comparing radiotherapy plus surgery with the same type of surgery alone, 10 comparing more extensive surgery with less extensive surgery, and 18 comparing more extensive surgery with less extensive surgery plus radiotherapy. Information on mortality was available for 28,405 women (97.4 percent of the 29,175 women in the trials).
The addition of radiotherapy to surgery resulted in a rate of local recurrence that was three times lower than the rate with surgery alone, but there was no significant difference in 10-year survival; among a total of 17,273 women enrolled in such trials, mortality was 40.3 percent with radiotherapy and 41.4 percent without radiotherapy (P = 0.3). Radiotherapy was associated with a reduced risk of death due to breast cancer (odds ratio, 0.94; 95 percent confidence interval, 0.88 to 1.00; P = 0.03), which indicates that, after 10 years, there would be about 0 to 5 fewer deaths due to breast cancer per 100 women. However, there was an increased risk of death from other causes (odds ratio, 1.24; 95 percent confidence interval, 1.09 to 1.42; P = 0.002). This, together with the age-specific death rates, implies, after 10 years, a few extra deaths not due to breast cancer per 100 older women or per 1000 younger women. During the first decade or two after diagnosis, the excess in the rate of such deaths that was associated with radiotherapy was much greater women who were over 60 years of age at randomization (15.3 percent vs. 11.1 percent [339 vs. 249 deaths]) than among those under 50 (2.5 percent vs. 2.0 percent [62 vs. 49 deaths]). Breast-conserving surgery involved some risk of recurrence in the remaining tissue, but no significant differences in overall survival at 10 years were found in the studies of mastectomy versus breast-conserving surgery plus radiotherapy (4891 women), more extensive surgery versus less extensive surgery (4818 women), or axillary clearance versus radiotherapy as adjuncts to mastectomy (4370 women).
Some of the local therapies for breast cancer had substantially different effects on the rates of local recurrence--such as the reduced recurrence with the addition of radiotherapy to surgery--but there were no definite differences in overall survival at 10 years.
早期乳腺癌放疗与手术的随机试验规模可能过小，无法可靠地检测长期生存和复发方面的差异。因此，我们对这类试验的结果进行了系统综述（荟萃分析）。
向开展1985年前开始的、比较早期乳腺癌局部治疗方法的试验研究者索取每位受试者的信息。有36项试验提供了死亡率数据，这些试验比较了放疗加手术与单纯相同类型手术，10项试验比较了扩大手术与缩小手术，18项试验比较了扩大手术与缩小手术加放疗。28405名女性（占试验中29175名女性的97.4%）有死亡率数据。
手术加放疗使局部复发率比单纯手术降低了两倍，但10年生存率无显著差异；在这类试验中共纳入17273名女性，接受放疗者的死亡率为40.3%，未接受放疗者为41.4%（P = 0.3）。放疗与乳腺癌死亡风险降低相关（优势比，0.94；95%置信区间，0.88至1.00；P = 0.03），这表明，10年后，每100名女性中因乳腺癌死亡的人数将减少约0至5人。然而，其他原因导致的死亡风险增加（优势比，1.24；95%置信区间，1.09至1.42；P = 0.002）。这与特定年龄死亡率一起表明，10年后，每100名老年女性或每1000名年轻女性中会有一些非乳腺癌导致的额外死亡。在诊断后的头一二十年里，与放疗相关的此类死亡发生率在随机分组时年龄超过60岁的女性中（15.3%对11.1%[339对249例死亡]）比50岁以下女性中（2.5%对2.0%[62对49例死亡]）高得多。保乳手术使剩余组织存在一定的复发风险，但在乳房切除术与保乳手术加放疗（4891名女性）、扩大手术与缩小手术（4818名女性）或腋窝清扫与放疗作为乳房切除术辅助手段（4370名女性）的研究中，10年总生存率无显著差异。
一些乳腺癌局部治疗方法对局部复发率有显著不同的影响——如手术加放疗可降低复发率——但10年总生存率无明确差异。
