van Dongen J A, Voogd A C, Fentiman I S, Legrand C, Sylvester R J, Tong D, van der Schueren E, Helle P A, van Zijl K, Bartelink H
Department of Surgery, The Netherlands Cancer Institute, Amsterdam.
J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.
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.
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.
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).
BCT and mastectomy demonstrate similar survival rates in a trial in which the great majority of the patients had stage II breast cancer.
保乳治疗（BCT）已被证明在治疗2厘米及以下肿瘤方面与乳房切除术效果相同。然而，其对大于2厘米肿瘤患者的长期疗效证据有限。1980年5月至1986年5月，欧洲癌症研究与治疗组织开展了一项随机、多中心试验，比较BCT与改良根治性乳房切除术对肿瘤最大达5厘米患者的疗效。在本分析中，我们研究了这两种治疗方法是否导致不同的总生存率、远处转移时间或局部区域复发时间。
868例符合条件的乳腺癌患者被随机分配至BCT组或改良根治性乳房切除术组，其中80%的患者肿瘤大小为2.1 - 5厘米。BCT包括肿块切除术，切缘距健康组织1厘米，并进行腋窝淋巴结清扫，随后对乳房进行放疗，并对瘤床追加剂量。中位随访时间为13.4年。所有P值均为双侧。
10年时，两组在总生存率（乳房切除术患者为66%，BCT患者为65%；P = 0.11）或无远处转移率（乳房切除术患者为66%，BCT患者为61%；P = 0.24）方面无差异。10年时局部区域复发率（在远处转移之前或同时发生）确实存在统计学显著差异（乳房切除术患者为12%，BCT患者为20%；P = 0.01）。
在一项大多数患者为II期乳腺癌的试验中，BCT和乳房切除术显示出相似的生存率。
