Safety and efficacy results of a randomized trial comparing adjuvant toremifene and tamoxifen in postmenopausal patients with node-positive breast cancer
Safety and efficacy results of a randomized trial comparing adjuvant toremifene and tamoxifen in postmenopausal patients with node-positive breast cancer
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DOI：
10.1200/jco.2000.18.20.3487
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发表时间：
2000-10-15
影响因子：
45.3
通讯作者：
Joensuu, H
中科院分区：
文献类型：
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作者：
Holli, K;Valavaara, R;Joensuu, H
目的：在这项多中心试验中，托瑞米芬 40 mg/d 与他莫昔芬 20 mg/d 进行比较，两者均口服给药 3 年，给绝经后、腋窝淋巴结阳性的乳房手术后女性。患者和方法：纳入试验的 1.480 名患者中的前 899 名患者（托瑞米芬，n = 459；他莫昔芬，n = 440）在此预定的安全分析中。平均随访时间为 3.4 年。结果：两个治疗组在患者和疾病特征方面取得了很好的平衡。两个治疗组的主观副作用相似。与托瑞米芬治疗的患者 (3.5%) 相比，他莫昔芬治疗的患者 (5.9%) 的血管并发症（深静脉血栓、脑血管事件和肺栓塞）稍多 (P = .11)，而托瑞米芬组骨折 (P = .09) 和阴道白带 (P = .05) 更常见。随后发生的第二次癌症的数量相似。托瑞米芬组和他莫昔芬组的乳腺癌复发率为 23.1% (n = 106) 和 26.1% (n = 115) (P = .31)。当仅考虑雌激素受体 (ER) 阳性癌症患者 (n = 556) 时，接受托瑞米芬治疗的女性乳腺癌复发风险无显着降低，风险比为 0.74（90% 置信区间，0.52 至 1.04；P = .14）。两组的乳腺癌平均复发时间和总生存期相似。结论：托瑞米芬的副作用特征与他莫昔芬相似。托瑞米芬的功效似乎并不亚于他莫昔芬。 ER 阳性亚组中乳腺癌复发率下降的趋势令人鼓舞，(C) 2000，美国临床肿瘤学会 (American Society of Clinical Oncology) 的报告。
Purpose: In this multicenter trial, toremifene 40 mg/d was compared with tamoxifen 20 mg/d, both given orally for 3 years to postmenopausal, axillary node-positive women after breast surgery.Patients and Methods: The first 899 patients (toremifene, n = 459; tamoxifen, n = 440) of the total of 1.480 patients accrued to the trial were included in this scheduled safety analysis. The mean follow-up time was 3.4 years.Results: The two treatment groups were well balanced with respect to patient and disease characteristics. The subjective side-effect profile wets similar in both treatment groups. Slightly more vascular complications (deep vein thromboses, cerebrovascular events, and pulmonary embolisms) were seen among tamoxifen-treated patients (5.9%) as compared with toremifene-treated patients (3.5%) (P = .11), whereas bone fractures (P = .09) and vaginal leukorrhea (P = .05) were more common in the toremifene group. The number of subsequent second cancers wets similar. The breast cancer recurrence rate was 23.1% (n = 106) in the toremifene group and 26.1% (n = 115) in the tamoxifen group (P = .31). When only patients with estrogen receptor (ER)-positive cancer were considered (n = 556), the risk for breast cancer recurrence was nonsignificantly lower among the toremifene-treated women, with a hazards ratio of 0.74 (90% confidence interval, 0.52 to 1.04; P = .14). The mean time to breast cancer recurrence and overall survival were similar in both groups.Conclusion: The side-effect profile of toremifene resembles that of tamoxifen. The efficacy of toremifene seems to be no less than that of tamoxifen. The trend for fewer breast cancer recurrences in the ER-positive subgroup is encouraging, (C) 2000 by American Society of Clinical Oncology.