Blichert-Toft Mogens, Nielsen Maja, Düring Maria, Møller Susanne, Rank Fritz, Overgaard Marie, Mouridsen Henning T
The Danish Breast Cancer Cooperative Group, DBCG, Rigshospitalet, Copenhagen, Denmark.
Acta Oncol. 2008;47(4):672-81. doi: 10.1080/02841860801971439.
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<0.001). In conclusion, long-term data indicate that BCS in eligible patients proves as effective as mastectomy both regarding local tumour control, RFS and OS. Local failures as a first event consistent with new primaries are strongly associated with BCS, whereas true recurrence predominates after mastectomy.
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）于1983年1月至1989年3月开展了该项试验（DBCG - 82TM），招募了1154例浸润性乳腺癌患者。随访时间截至2006年5月1日，中位随访时间为19.6年（时间跨度为17.1 - 23.3年）。入选标准包括单侧、单灶、原发性可手术乳腺癌，患者年龄低于70岁，保乳手术有满意美容效果的可能性，且无播散性疾病证据。纳入的患者分为三个亚组：正确随机分组、怀疑随机误差和拒绝随机分组。主要分析集中在793例正确随机分组的患者亚组，占完整系列的70%。基于意向性分析的10年无复发生存率（RFS）和20年总生存率（OS）显示，保乳手术与乳房切除术在结局上无显著差异，p值分别为0.95和0.10。纳入基于实际接受治疗的1133例符合条件患者的完整系列，在10年RFS和20年OS结局中，手术方式之间同样未发现显著差异，p值分别为0.94和0.24。保乳手术与乳房切除术作为首次事件的复发模式在部位方面无显著差异，p = 0.27。研究局部复发类型，即新发原发性肿瘤与真性复发，发现新发原发性肿瘤与保乳手术显著相关，而真性复发在接受乳房切除术的患者中占主导（p < 0.001）。总之，长期数据表明，符合条件的患者行保乳手术在局部肿瘤控制、RFS和OS方面与乳房切除术同样有效。作为首次事件与新发原发性肿瘤一致的局部失败与保乳手术密切相关，而乳房切除术后真性复发占主导。
