Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer:: 20-year follow-up of the Danish randomized DBCG-82TM protocol
Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer:: 20-year follow-up of the Danish randomized DBCG-82TM protocol
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DOI：
10.1080/02841860801971439
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发表时间：
2008-01-01
期刊：
影响因子：
3.1
通讯作者：
Mouridsen, Henning T.
中科院分区：
文献类型：
--
作者：
Blichert-Toft, Mogens;Nielsen, Maja;Mouridsen, Henning T.
本研究的主要目的是基于随机设计比较保乳手术 (BCS) 与乳房切除术 (M) 的长期疗效。丹麦乳腺癌合作组 (DBCG) 从 1983 年 1 月至 1989 年 3 月进行了这项试验 (DBCG-82TM)，招募了 1154 名浸润性乳腺癌患者。随访时间截至2006年5月1日，中位随访时间为19.6年（时间跨度17.1-23.3年）。资格标准包括单侧、单灶、原发性可手术乳腺癌、患者年龄低于 70 岁、BCS 获得满意美容效果的可能性以及没有播散性疾病的证据。累积的患者被分为三个亚组：正确随机化、怀疑随机化错误和随机化下降。主要分析集中在 793 名正确随机化患者组成的亚组，占整个系列的 70%。基于治疗意图的 10 年无复发生存率 (RFS) 和 20 年总生存率 (OS) 并未显示保乳手术与乳房切除术之间的结果存在显着差异，分别为 p = 0.95 和 p = 0.10。包括由 1133 名符合条件的患者组成的完整系列，事实上，同样给予的治疗，手术选择之间没有显着差异，可以在 10 年 RFS 和 20 年 OS 的结果中追踪到，分别为 p = 0.94 和 p = 0.24。 无论部位如何，保乳与乳房切除术中作为首次事件的复发模式没有显着差异，p = 0.27。研究局部复发的类型，即新原发灶与真实复发，似乎新原发灶与 BCS 显着相关，而真正复发在 M 治疗患者中占主导地位 (p
The main objective of the present study aims at comparing the long-term efficacy of breast conserving surgery (BCS) vs. mastectomy (M) based on a randomized design. The Danish Breast Cancer Cooperative Group (DBCG) conducted the trial (DBCG-82TM) from January 1983 to March 1989 recruiting 1154 patients with invasive breast carcinoma. Follow-up time ended 1(st) May 2006 with a median follow-up time of 19.6 years (time span 17.1-23.3 years). Eligibility criteria included a one-sided, unifocal, primary operable breast carcinoma, patient age below 70 years, probability of satisfactory cosmetic outcome with BCS, and no evidence of disseminated disease. The patients accrued were grouped into three subsets: correctly randomized, suspicion of randomization error, and declining randomization.The main analyses focus on the subgroup of 793 correctly randomized patients representing 70% of the complete series. 10-year recurrence free survival (RFS) and 20-year overall survival (OS) based on intent to treat did not reveal significant differences in outcome between breast conserving surgery vs. mastectomy, p =0.95 and p =0.10, respectively. Including the complete series comprising 1133 eligible patients based on treatment in fact given similarly no significant difference between surgical options could be traced in outcome of 10-year RFS and 20-year OS, p =0.94 and p =0.24, respectively.The pattern of recurrences as a first event in breast conservation vs. mastectomy did not differ significantly irrespective of site, p =0.27. Looking into the type of local relapse, viz., new primaries vs. true recurrences, it appeared that new primaries were significantly associated to BCS, while true recurrences dominated among M treated patients (p