目的探讨托瑞米芬在中国绝经后可手术luminal型乳腺癌中的作用。方法收集2000年1月至2009年12月期间中山大学肿瘤防治中心收治的绝经后luminal型乳腺癌患者的临床病理资料,使用他莫昔芬(组)或托瑞米芬(组)辅助内分泌治疗共618例(分别为503例和115例)。采用Kaplan-Meier法和log-rank检验分析2组生存情况,Cox比例风险回归模型进行多因素分析。结果托瑞米芬组和他莫昔芬组患者的一般临床病理特征比较差异无统计学意义(P>0.05),具有可比性。全组中位随访时间76个月。托瑞米芬组和他莫昔芬组5年无病生存率和5年总生存率比较,差异均无统计学意义(5年无病生存率:78.5%比85.5%,P=0.083;5年总生存率:86.4%比92.0%,P=0.334)。单因素分析结果显示,组织学分级高、肿块大、淋巴结阳性、分期晚和HER-2阳性是影响绝经后可手术luminal型乳腺癌患者无病生存率和总生存率的不良预后因素(P<0.05);多因素分析结果显示,肿块大小和淋巴结状态是影响luminal型乳腺癌患者总生存率和无病生存率的独立预后因素(P<0.05)。HER-2阳性是影响无病生存率的独立预后因素(P<0.05)。全组未见CTC AE 4.0分级为3/4度的不良反应。结论与他莫昔芬相比,托瑞米芬治疗绝经后可手术luminal型乳腺癌疗效相似,安全性高。HER-2表达状况影响绝经后可手术luminal型乳腺癌患者的无病生存率。 Objective To investigate the role of toremifene in luminal breast cancer in China after menopause. Methods The clinical and pathological data of luminal breast cancer in postmenopausal women who were admitted to Cancer Center of Sun Yat-sen University from January 2000 to December 2009 were collected, and tamoxifen (group) and toremifene (group) were used to assist the endocrine therapy A total of 618 cases (503 cases and 115 cases, respectively). Kaplan-Meier method and log-rank test were used to analyze the survival of two groups and Cox proportional hazards regression model for multivariate analysis. Results The clinicopathological features of toremifene group and tamoxifen group were not significantly different (P> 0.05), comparable. The median time of follow-up was 76 months. There was no significant difference in 5-year disease-free survival rate and 5-year overall survival rate between toremifene group and tamoxifen group (5-year disease-free survival rate: 78.5% vs. 85.5%, P = 0.083; 5 The overall survival rate was 86.4% vs. 92.0%, P = 0.334). Univariate analysis showed that histological grade, mass, lymph node positive, staging and HER-2 positive were the prognostic factors influencing the disease-free survival and overall survival rate of patients with postoperative luminal breast cancer (P < 0.05). Multivariate analysis showed that tumor size and lymph node status were independent prognostic factors for overall survival and disease-free survival in patients with luminal breast cancer (P <0.05). HER-2 positivity was an independent prognostic factor affecting disease-free survival (P <0.05). The whole group did not see the CTC AE 4.0 grade 3/4 degrees of adverse reactions. Conclusion Compared with tamoxifen, toremifene treatment of postmenopausal luminal breast cancer with similar efficacy and safety. The expression of HER-2 affects the disease-free survival of patients with luminal breast cancer after surgery.