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ZEBRA研究的生存分析。戈舍瑞林(诺雷德)与CMF方案治疗绝经前淋巴结阳性乳腺癌患者的对比研究。

Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer.

作者信息

Kaufmann M, Jonat W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes J C, Schumacher M, Sauerbrei W

机构信息

Universitäts-Frauenklinik, Frankfurt, Germany.

出版信息

Eur J Cancer. 2003 Aug;39(12):1711-7. doi: 10.1016/s0959-8049(03)00392-7.

Abstract

The Zoladex Early Breast Cancer Research Association (ZEBRA) trial compared the efficacy and tolerability of goserelin (Zoladex) with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) chemotherapy in pre-/perimenopausal women with node-positive early breast cancer. The results of disease-free survival (DFS) analyses have already been published. Here we present an update including data on overall survival (OS) from the ZEBRA trial at a median follow-up of 7.3 years. In patients with oestrogen receptor (ER)-positive tumours, non-inferiority of goserelin versus CMF for OS was shown; goserelin was again shown to be equivalent to CMF for DFS. This updated analysis has demonstrated that the two treatments are also equivalent for distant disease-free survival (DDFS). In patients with ER-negative disease, goserelin was inferior to CMF for DFS, DDFS and OS. This follow-up analysis confirms the previously reported outcomes from the ZEBRA trial and demonstrates that goserelin offers an effective alternative to CMF chemotherapy for adjuvant therapy of premenopausal patients with ER-positive, node-positive early breast cancer.

摘要

戈舍瑞林早期乳腺癌研究协会(ZEBRA)试验比较了戈舍瑞林(诺雷德)与环磷酰胺、甲氨蝶呤和5-氟尿嘧啶(CMF)化疗方案在绝经前/围绝经期淋巴结阳性早期乳腺癌女性患者中的疗效和耐受性。无病生存(DFS)分析结果已经发表。在此,我们给出一项更新内容,包括ZEBRA试验中位随访7.3年时的总生存(OS)数据。在雌激素受体(ER)阳性肿瘤患者中,显示戈舍瑞林在OS方面不劣于CMF;戈舍瑞林在DFS方面再次显示与CMF相当。这一更新分析表明,两种治疗方案在远处无病生存(DDFS)方面也相当。在ER阴性疾病患者中,戈舍瑞林在DFS、DDFS和OS方面均劣于CMF。此次随访分析证实了ZEBRA试验先前报道的结果,并表明戈舍瑞林为绝经前ER阳性、淋巴结阳性早期乳腺癌患者的辅助治疗提供了一种有效的CMF化疗替代方案。

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