Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial
Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial
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DOI：
10.1093/jnci/92.14.1143
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发表时间：
2000-07-19
影响因子：
10.3
通讯作者：
Bartelink, H
中科院分区：
文献类型：
--
作者：
van Dongen, JA;Voogd, AC;Bartelink, H
背景：在治疗2厘米或更小的肿瘤时，保乳治疗（BCT）已被证明与乳房切除术一样有效。然而，在肿瘤大于2厘米的患者中，其长期疗效的证据有限。从1980年5月到1986年5月，欧洲癌症研究和治疗组织进行了一项随机多中心试验，比较BCT和改良根治性乳房切除术治疗肿瘤达5厘米的患者，在这项分析中，我们调查了两种治疗是否导致不同的总生存率、远处转移时间或局部复发时间。方法：在868名符合条件的乳腺癌患者中，随机分配到BCT组或改良根治性乳房切除术组，80%的患者肿瘤面积为2.1-5 cm， BCT包括乳房肿瘤切除术，尝试切除1 cm的健康组织并完全清除腋窝，然后进行乳房放疗和肿瘤床补充剂量。中位随访时间为13.4年。所有P值都是双面的。结果:在10年,两组之间没有差别整体存活率(66%旅级战斗队患者乳房切除术患者和65%;P =厚)或在遥远的metastasis-free利率(66%的旅级战斗队患者乳房切除术患者和61%;P = .24),局部区域复发的速度(之前或同时发生远处转移)在10年确实展现出了一种统计上的显著差异(12%的乳房切除术和旅级战斗队病人的20%;P = . 01)。结论：在绝大多数II期乳腺癌患者的试验中，BCT和乳房切除术显示出相似的生存率。
Background: Breast-conserving therapy (BCT) has been shown to be as effective as mastectomy in the treatment of tumors 2 cm or smaller. However, evidence of its efficacy, over the long term, in patients with tumors larger than 2 cm is limited. From May 1980 to May 1986, the European Organization for Research and Treatment of Cancer carried out a randomized, multicenter trial comparing BCT with modified radical mastectomy for patients with tumors up to 5 cm, In this analysis, we investigated whether the treatments resulted in different overall survival, time to distant metastasis, or time to locoregional recurrence. Methods: Of 868 eligible breast cancer patients randomly assigned to the BCT arm or to the modified radical mastectomy arm, 80% had a tumor of 2.1-5 cm, BCT comprised lumpectomy with an attempted margin of 1 cm of healthy tissue and complete axillary clearance, followed by radiotherapy to the breast and a supplementary dose to the tumor bed. The median follow-up was 13.4 years. All P values are two-sided. Results: At 10 years, there was no difference between the two groups in overall survival (66% for the mastectomy patients and 65% for the BCT patients; P = .11) or in their distant metastasis-free rates (66% for the mastectomy patients and 61% for the BCT patients; P = .24), The rate of locoregional recurrence (occurring before or at the same time as distant metastasis) at 10 years did show a statistically significant difference (12% of the mastectomy and 20% of the BCT patients; P = .01). Conclusions: BCT and mastectomy demonstrate similar survival rates in a trial in which the great majority of the patients had stage II breast cancer.