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CMF方案与戈舍瑞林作为绝经前、淋巴结阴性、激素受体阳性乳腺癌辅助治疗的比较:一项随机试验(GABG试验IV-A-93)

CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor-positive breast cancer in premenopausal patients: a randomised trial (GABG trial IV-A-93).

作者信息

von Minckwitz Gunter, Graf Erika, Geberth Matthias, Eiermann Wolfgang, Jonat Walter, Conrad Bettina, Brunnert Klaus, Gerber Bernd, Vescia Sabine, Wollert Jörg, Kaufmann Manfred

机构信息

German Breast Group, Schleussnerstrase 42, 63263 Neu-Isenburg, Germany.

出版信息

Eur J Cancer. 2006 Aug;42(12):1780-8. doi: 10.1016/j.ejca.2006.04.006. Epub 2006 Jun 12.

DOI:10.1016/j.ejca.2006.04.006
PMID:16765589
Abstract

Gonadotrophin-releasing hormone analogues were investigated as adjuvant treatment for patients with node-negative, hormone-sensitive, premenopausal breast cancer. Patients were randomised to either three cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) chemotherapy (n=378) or goserelin every 28 d for 2 years (n=393). During a median follow-up of 4.9 years, 123 events were observed. The first-failure event of CMF versus goserelin, respectively, was ipsilateral locoregional recurrence (18 versus 20), contralateral breast cancer (7 versus 6), distant failure (35 versus 24) and death without recurrence (2 versus 2). Forty-two (23 versus 19) deaths of any cause occurred. The estimated adjusted hazard ratio for goserelin versus CMF (intention-to-treat analysis) was 0.79 (95% CI=0.54-1.14; P=0.19). It is concluded that medical ovarian ablation with goserelin represents a valid option for premenopausal patients with node-negative breast cancer.

摘要

促性腺激素释放激素类似物被作为淋巴结阴性、激素敏感的绝经前乳腺癌患者的辅助治疗方法进行了研究。患者被随机分为接受三个周期的环磷酰胺、甲氨蝶呤和5-氟尿嘧啶(CMF)化疗组(n = 378)或每28天注射戈舍瑞林共2年组(n = 393)。在中位随访4.9年期间,观察到123个事件。CMF组和戈舍瑞林组的首次失败事件分别为同侧局部区域复发(18例对20例)、对侧乳腺癌(7例对6例)、远处转移(35例对24例)以及无复发死亡(2例对2例)。发生了42例(23例对19例)任何原因导致的死亡。戈舍瑞林对比CMF的估计调整风险比(意向性分析)为0.79(95%CI = 0.54 - 1.14;P = 0.19)。结论是,戈舍瑞林进行药物性卵巢去势是淋巴结阴性绝经前乳腺癌患者的一种有效选择。

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