托瑞米芬治疗Luminal型年轻乳腺癌疗效和安全性的回顾性研究

【目的】 探讨托瑞米芬治疗年轻(≤35岁)可手术乳腺癌的疗效及安全性?【方法】 收集2002年1月至2007年10月诊治的绝经前年轻Luminal型乳腺癌的临床病理资料,使用他莫昔芬或托瑞米芬内分泌治疗共247例(分别为181例和66例)?采用Kaplan-Meier法和Log-rank检验分析两组生存情况,COX比率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中位年龄分别是33岁和32岁?全组中位随访77.1月,托瑞米芬组和他莫昔芬组的6年无病生存时间为77.0%和79.2%,6年总生存率分别为88.4%和87.4%,两组无病生存时间和总生存时间均无统计学差异(总生存时间, HR = 0.794; P = 0.589; 无病生存时间, HR = 1.132; P = 0.686)?托瑞米芬组和他莫昔芬组的毒性反应无统计学差异?单因素分析显示,肿块大?组织学分级高?分期晚和HER2过表达和患者无病生存时间较短相关;PR阴性患者可能无病生存时间短(P = 0.056);脉管癌栓?淋巴结阳性和分期晚的患者总生存时间较短?多因素分析提示HER2阳性和PR阴性预示年轻Luminal型可手术乳腺癌患者无病生存时间较短;分期较晚是该型患者的总生存时间差的预后因素? 【结论】 托瑞米芬治疗年轻绝经前Luminal型可手术乳腺癌疗效和他莫昔芬相似,安全性好?但仍需要更大规模的研究进一步来证实?

Efficacy and Safety of Toremifene in Young Patients with Luminal Subtype Early Breast Cancer: A Retrospective Study

【Objective】 There is no study about toremifene in the treatment of young breast cancer patients. This study aimed to compare the efficacy and safety of toremifene for young premenopausal breast cancer patients. 【Methods】 We retrospectively reviewed 247 young (≤35 years old) premenopausal Luminal type operable breast cancer patients, including 66 patients treated with toremifene and 181 patients treated with tamoxifen between January 2002 and October 2007. Survival was compared by Kaplan-Meier method with Log-rank test. Multivariate analysis was conducted by Cox hazard ratio regression model. 【Results】 Median age for toremifene and tamoxifen were 33 years and 32 years, respectively. After median follow-up duration of 77.1 months, 6-year disease-free survival was not significantly different between tamoxifen and toremifene (77.0% vs 79.2%, respectively). Similarly, 6-year overall survival was not significantly different between tamoxifen and toremifene (88.4% vs 87.4%, respectively). There was no difference between patients treated with toremifene versus tamoxifen in terms of overall survival (HR = 0.794;P = 0.589) and disease-free survival (HR = 1.132; P = 0.686). Adverse events were similar in the two groups. Univariated analysis showed that tumor size, grade, stage and HER2 overexpression were associated with short disease-free survival. Progesterone receptor status might affect disease-free survival (P = 0.056). Lymphovascular invasion, positive lymph node and advanced stage predicted poor overall survival. Multivariate analysis showed that HER2 overexpression and progesterone receptor negative were associated with short disease-free survival. Advanced stage was a predictor for unfavorable overall survival. 【Conclusion】 There was similar benefit in overall survival and disease-free survival in young premenopausal patients with operable breast cancer between patients receiving toremifene and tamoxifen. Further perspective clinical trials were needed to confirm the value of toremifene in adjuvant endocrine therapy for patients with premenopausal breast cancer.