Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association Study
Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association Study
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DOI：
10.1200/jco.2002.05.042
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发表时间：
2002-12-15
影响因子：
45.3
通讯作者：
Lisboa, B
中科院分区：
文献类型：
--
作者：
Jonat, W;Kaufmann, M;Lisboa, B
目的：目前的辅助治疗提高了绝经前乳腺癌患者的生存率，但可能有短期毒性作用和与过早绝经相关的长期影响。患者和方法：Zoladex早期乳腺癌研究协会的研究评估了戈舍林（每28天3.6 mg，持续2年；n=817）与环磷酰胺、甲氨蝶呤和氟尿嘧啶（CMF）化疗（6个28天周期；n=823）辅助治疗绝经前淋巴结阳性乳腺癌患者的疗效和耐受性。结果：共发生684例事件，中位随访时间为6年。治疗与雌激素受体（ER）状态之间存在显著的相互作用（P= 0.0016）。在er阳性患者（约74%）中，戈舍雷林与CMF的无病生存（DFS）相当（风险比[HR]为1.01；95%可信区间[CI]为0.84至1.20）。在er阴性患者中，戈舍林治疗DFS的效果不如CMF （HR, 1.76; 95% CI, 1.27 - 2.44）。戈舍雷林患者6个月闭经发生率超过95%，而CMF患者为58.6%。大多数戈舍雷林患者在停止治疗后月经恢复，而CMF患者的闭经通常是永久性的（3年闭经22.6% vs 76.9%）。化疗相关的副作用，如恶心/呕吐、脱发和感染，在CMF治疗期间，CMF比戈舍林高。与雌激素抑制相关的副作用最初与戈舍雷林较高，但当戈舍雷林治疗停止后，降低到低于CMF组观察到的水平。结论：戈舍雷林为绝经前er阳性和淋巴结阳性早期乳腺癌患者提供了一种有效且耐受性良好的CMF替代方案。
Purpose: Current adjuvant therapies have improved survival for premenopausal patients with breast cancer but may have short-term toxic effects and long-term effects associated with premature menopause.Patients and Methods: The Zoladex Early Breast Cancer Research Association study assessed the efficacy and tolerability of goserelin (3.6 mg every 28 days for 2 years; n=817) versus cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy (six 28-day cycles; n=823) for adjuvant treatment in premenopausal patients with node-positive breast cancer.Results: Analysis was performed when 684 events had been achieved, and the median follow-up was 6 years. A significant interaction between treatment and estrogen receptor (ER) status was found (P=.0016). In ER-positive patients (approximately 74%), goserelin was equivalent to CMF for disease-free survival (DFS) (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.84 to 1.20). In ER-negative patients, goserelin was inferior to CMF for DFS (HR, 1.76; 95% CI, 1.27 to 2.44). Amenorrhea occurred in more than 95% of goserelin patients by 6 months versus 58.6% of CMF patients. Menses returned in most goserelin patients after therapy stopped, whereas amenorrhea was generally permanent in CMF patients (22.6% v 76.9% amenorrheic at 3 years). Chemotherapy-related side effects such as nausea/vomiting, alopecia, and infection were higher with CMF than with goserelin during CMF treatment. Side effects related to estrogen suppression were initially higher with goserelin, but when goserelin treatment stopped, reduced to a level below that observed in the CMF group.Conclusion: Goserelin offers an effective, well-tolerated alternative to CMF in premenopausal patients with ER-positive and node-positive early breast cancer.