369例ER阳性乳腺癌辅助内分泌治疗的前瞻性临床研究

目的 评价ER阳性乳癌根治术后辅助内分泌治疗的效果。方法 ER阳性的根治性术后乳腺癌患者分为内分泌治疗及化疗两组，进行全身辅助治疗。内分泌治疗组194例，服用三苯氧胺（TAM）5年，其中绝经前患者均先切除双侧卵巢后再服用TAM。化疗组175例，主要采用CMFVP或CMF方案。结果 绝经后患者的内分泌治疗组和化疗组5年无病生存率分别为78．4％和45．4％（P＜0．01），5年总生存率分别为83．3％和52．9％（P＜0．05）；绝经前患者的内分泌治疗组和化疗组5年无病生存率分别为72．8％和35．7％（P＜0．01）。5年总生存率分别为80．7％和60．0％（P＜0．05）。但是Ⅰ期患者及腋淋巴结转移≥8个的患者，两者疗效差异无显著性（P＞0．05）。结论 ER阳性乳腺癌术后辅助内分泌治疗效果优于或等于化疗。

Prospective randomized trial on the efficacy of adjuvant endocrine therapy for ER-positive breast cancer patients after radical mastectomy

OBJECTIVE: To asses the efficacy of adjuvant endocrine therapy in ER-positive breast cancer patients after radical mastectomy. METHODS: 369 estrogen receptor (ER)-positive breast cancer patients were divided into two groups after radical mastectomy: 1. Endocrine group (N-194). The postmenopausal patients in this group received oral tamoxifen (TAM) for five years and the premenopausal patients were first treated with bilateral ovary ablation and, then, given TAM for five years. 2. The chemotherapy group patients (N-175) received CTX + MTX + 5-Fu + VCR + DXM) (CMFVP) or CTX + MTX + 5-Fu (CMF) multi-drug chemotherapy. RESULTS: Postmenopausal patients in the endocrine and chemotherapy groups gave disease-free survival rates (DFSR) of 78.4% and 45.4% (P < 0.01). Their overall survival rates were 83.3% and 52.9% (P < 0.05). The premenopausal patients gave DFSR of 72.8% and 35.7% (P < 0.01), and their overall survival rates were 80.7% and 60.6% (P < 0.05). But, no significant difference was observed in the stage I patients and those having > or = 8 axillary lymph node metastases (P > 0.05). CONCLUSION: For ER-positive breast cancer patients, the adjuvant endocrine therapy gives results superior or equal to multi-drug chemotherapy after radical mastectomy.