Kaufmann M, Jonat W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes J C, Schumacher M, Sauerbrei W
Universitäts-Frauenklinik, Frankfurt, Germany.
Eur J Cancer. 2003 Aug;39(12):1711-7. doi: 10.1016/s0959-8049(03)00392-7.
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.
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。
