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[乳腺癌肿瘤切除与乳房切除术的随机研究。2. DBCG-82TM(丹麦乳腺癌协作组)方案的6年结果]

[A randomized study of tumor resection versus mastectomy in breast cancer. 2. 6-year results of the DBCG-82TM (Danish Breast Cancer Cooperative Group) protocol].

出版信息

Ugeskr Laeger. 1991 Aug 12;153(33):2272-6.

PMID:1781045
Abstract

The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial to compare breast conservation with mastectomy in patients suffering from mammary carcinoma. From January 1983 to March 1989 the trial recruited a total of 1,153 women. Of these 905 patients (79%) were randomly assigned to one of two treatment options, whereas 248 patients (21%) refused randomization. Of the randomized patients, 90% received the surgical option to which they had been originally assigned. As regards breast conservation, the tumour was excised with the object of tumour-free margins on gross examination, and radiotherapy was administered subsequently to residual breast tissue. Mastectomy was performed as a modified radical procedure. The axilla was dissected in all instances. Patient and tumour characteristics were similar in the two random groups. The median follow-up time was 40 months. At 6 years of life table analysis the probability of recurrence free survival was 70% in the breast conservation group compared with 66% in the mastectomy group. Survival figures were 79% compared with 82%, respectively. Short-term follow-up did not disclose any significant difference between results of breast conservation compared with those of mastectomy. On the other hand, in the non-randomized group the patients undergoing breast conservation had a significantly poorer outcome than the patients treated with mastectomy.

摘要

丹麦乳腺癌协作组(DBCG)进行了一项随机试验,以比较乳腺癌患者保乳手术与乳房切除术的效果。从1983年1月至1989年3月,该试验共招募了1153名女性。其中905名患者(79%)被随机分配到两种治疗方案之一,而248名患者(21%)拒绝随机分组。在随机分组的患者中,90%接受了最初分配给他们的手术方案。对于保乳手术,在大体检查时以切缘无肿瘤为目标切除肿瘤,随后对残留乳腺组织进行放疗。乳房切除术采用改良根治术。所有病例均进行腋窝清扫。两个随机分组的患者和肿瘤特征相似。中位随访时间为40个月。在6年的生命表分析中,保乳组无复发生存的概率为70%,而乳房切除组为66%。生存率分别为79%和82%。短期随访未发现保乳手术结果与乳房切除术结果之间存在任何显著差异。另一方面,在非随机分组中,接受保乳手术的患者的结局明显比接受乳房切除术的患者差。

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