University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Cancer. 2010 May 15;116(10):2307-15. doi: 10.1002/cncr.24940.
Fareston (toremifene) and tamoxifen, both selective estrogen receptor modulators, are therapeutically equivalent treatments for metastatic breast cancer. We hypothesized that toremifene as compared with tamoxifen given as adjuvant therapy for early stage breast cancer would result in equivalent survival with an improved side effect profile, therefore, providing superior therapeutic efficacy.
The North American Fareston versus Tamoxifen Adjuvant trial assigned 1813 perimenopausal or postmenopausal women with hormone receptor (HR)-positive invasive breast cancer to adjuvant treatment with either tamoxifen or toremifene. The primary outcomes evaluated were disease-free survival (DFS) and overall survival (OS).
Median follow-up was 59 months. The baseline characteristics of the 2 treatment groups were well-balanced. On the basis of intent-to-treat, 5-year actuarial DFS was not significantly different between tamoxifen and toremifene (91.2% [standard error of the mean [SE] 1.2%] vs 91.2% [SE 1.1%], respectively). Similarly, 5-year actuarial OS was not significantly different between tamoxifen and toremifene (92.7% [SE 1.1%] vs 93.7% [SE 1.0%], respectively). Controlling for patient age, tumor size, and tumor grade, a Cox multivariate survival analysis found no difference between patients randomized to toremifene versus tamoxifen in terms of OS (OR = 0.951; 95% confidence interval [CI], 0.623-1.451, P = .951) or DFS (OR = 1.037; 95% CI, 0.721-1.491, P = .846). Adverse events were similar in the 2 groups.
Women treated with adjuvant hormonal therapy enjoyed excellent DFS and OS. No significant differences were found between treatment with either tamoxifen or toremifene. Treatment of HR-positive patients with either tamoxifen or toremifene is appropriate.
法乐通（托瑞米芬）和他莫昔芬都是选择性雌激素受体调节剂，对转移性乳腺癌的治疗效果相当。我们假设，与他莫昔芬相比，用于早期乳腺癌辅助治疗的托瑞米芬在具有改善的副作用特征的同时，能够获得等效的生存获益，从而提供更好的治疗效果。
北美法乐通与他莫昔芬辅助治疗试验将 1813 例围绝经期或绝经后激素受体（HR）阳性浸润性乳腺癌患者随机分配接受他莫昔芬或托瑞米芬辅助治疗。主要终点评估是无病生存期（DFS）和总生存期（OS）。
中位随访时间为 59 个月。两组患者的基线特征均衡。基于意向治疗分析，他莫昔芬组和托瑞米芬组 5 年无病生存率无显著差异（91.2%[均数标准差（SE）1.2%]与 91.2%[SE 1.1%]）。同样，他莫昔芬组和托瑞米芬组 5 年总生存率也无显著差异（92.7%[SE 1.1%]与 93.7%[SE 1.0%]）。在控制患者年龄、肿瘤大小和肿瘤分级后，Cox 多变量生存分析发现，随机分配至托瑞米芬组和他莫昔芬组的患者在 OS（风险比[OR] = 0.951；95%置信区间[CI]，0.623-1.451，P =.951）和 DFS（OR = 1.037；95%CI，0.721-1.491，P =.846）方面无差异。两组的不良反应相似。
接受辅助激素治疗的女性DFS 和 OS 均极佳。他莫昔芬和托瑞米芬治疗组之间未发现显著差异。HR 阳性患者应用他莫昔芬或托瑞米芬治疗均合适。
