Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: Results from INT 0101 (E5188)
Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: Results from INT 0101 (E5188)
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DOI：
10.1200/jco.2005.05.551
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发表时间：
2005-09-01
影响因子：
45.3
通讯作者：
Abeloff, MD
中科院分区：
文献类型：
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作者：
Davidson, NE;O'Neill, AM;Abeloff, MD
目的 化疗、他莫昔芬以及卵巢去势/抑制（OA/OS）是绝经前、类固醇激素受体阳性乳腺癌的有效辅助治疗方法。联合治疗的价值尚未明确确定。
患者与方法 将腋窝淋巴结阳性、类固醇激素受体阳性的绝经前乳腺癌女性（1503例符合条件的患者）随机分配接受6个周期的环磷酰胺、多柔比星和氟尿嘧啶（CAF）治疗，CAF后接着接受5年每月戈舍瑞林治疗（CAF - Z），或者CAF后接着接受5年每月戈舍瑞林和每日他莫昔芬治疗（CAF - ZT）。主要终点是CAF - Z对比CAF的复发时间（TTR）、无病生存期（DFS）和总生存期（OS），以及CAF - ZT对比CAF - Z的这些指标。
结果 中位随访9.6年，在CAF - Z中加入他莫昔芬改善了TTR和DFS，但未改善OS。在CAF中加入戈舍瑞林没有总体优势。
结论 在CAF - Z中加入他莫昔芬可改善绝经前淋巴结阳性、受体阳性乳腺癌的预后。应更深入地研究OA/OS单独使用或与其他内分泌药物联合使用的作用。
Purpose Chemotherapy, tamoxifen, and ovarian ablation/suppression (OA/OS) are effective adjuvant approaches for premenopausal, steroid hormone receptor-positive breast cancer. The value of combined therapy has not been clearly established.Patients and Methods Premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer (1,503 eligible patients) were randomly assigned to six cycles of cyclophosphamide, doxorubicin, and fluorouracil (CAF), CAF followed by 5 years of monthly goserelin (CAF-Z), or CAF followed by 5 years of monthly goserelin and daily tamoxifen (CAF-ZT). The primary end points were time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS) for CAF-Z versus CAF, and CAF-ZT versus CAF-Z.Results With a median follow-up of 9.6 years, the addition of tamoxifen to CAF-Z improved TTR and DFS but not OS. There was no overall advantage for addition of goserelin to CAF.Conclusion Addition of tamoxifen to CAF-Z improves outcome for premenopausal node-positive, receptor-positive breast cancer. The role of OA/OS alone or with other endocrine agents should be studied more intensely.