Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: Results of overview analysis of two phase III trials
Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: Results of overview analysis of two phase III trials
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DOI：
10.1200/jco.1996.14.7.2000
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发表时间：
1996-07-01
影响因子：
45.3
通讯作者：
Plourde, PV
中科院分区：
文献类型：
--
作者：
Buzdar, A;Jonat, W;Plourde, PV
目的：比较选择性非甾体类芳香酶抑制剂阿那曲唑(1 mg/d和10 mg/d)和醋酸甲地孕酮(40 mg/d，4次/d)治疗绝经后三苯氧胺(Tamoxifen)进展的患者的疗效和耐受性。因为两个试验在设计上是相同的，所以对合并的结果进行了分析，以加强对每个试验结果的解释。结果：平均随访时间约为6个月。阿那曲唑1 mg与甲地孕酮的进展风险比估计为0.97(97.5%可信区间[CI]，0.75~1.24)，阿那曲唑10 mg与甲地孕酮的进展危险比为0.92(97.5%CI，0.71~1.19)。总体进展的中位数约为21周。每组中约三分之一的患者从治疗中受益。阿那曲唑1 mg组27例(10.3%)、阿那曲唑10 mg组22例(8.9%)、甲地孕酮组20例(7.9%)完全或部分缓解，分别有66例(25.1%)、56例(22.6%)和66例(26.1%)患者病情稳定时间大于或等于24周。阿那曲唑和甲地孕酮耐受性良好。阿那曲唑组患者的胃肠功能障碍比甲地孕酮组更为常见；阿那曲唑10 mg组与甲地孕酮组之间的差异有统计学意义(P=0.005)。服用阿那曲唑1毫克(P<；.0001)和10毫克(P<；.002)的患者体重增加的人数明显少于服用甲地孕酮的患者，服用甲地孕酮的患者中，超过30%的患者体重增加大于或等于5%，10%的患者体重增加大于或等于10%。接受甲地孕酮治疗的患者随着时间的推移体重持续增加。结论：阿那曲唑，每天1次和10 mg，耐受性良好，与甲地孕酮一样有效，治疗绝经后经他莫昔芬治疗进展的晚期乳腺癌。此外，阿那曲唑治疗避免了与甲地孕酮治疗相关的体重增加。
Purpose: To compare the efficacy and tolerability of anastrozole (1 and 10 mg once daily), a selective, ems, nonsteroidal aromatase inhibitor, and megestrol acetate (40 mg four times daily), in postmenopausal women who progressed following tamoxifen treatment.Patients and Methods: Two randomized, double-blind for anastrozole, open-label for megestrol acetate, parallel-group, multicenter trials were conducted in 764 patients. Because both trials were identical in design, an analysis of the combined results was performed to strengthen interpretation of results from each trial.Results: The median follow-up duration was approximately 6 months. The estimated progression hazards ratios were 0.97 (97.5% confidence interval [Cl], 0.75 to 1.24) for anastrozole 1 mg versus megestrol acetate and 0.92 (97.5% Cl, 0.71 to 1.19) for anastrozole 10 mg versus megestrol acetate. The overall median rime to progression was approximately 21 weeks. Approximately one third of patient in each group benefited from treatment. Twenty-seven patients (10.3%) in the anastrozole 1-mg group, 22 (8.9%) in the anastrozole 10-mg group, and 20 (7.9%) in the megestrol acetate group had a complete or partial response, and 66 (25.1%), 56 (22.6%), and 66 (26.1%) patients, respectively, had stable disease for greater than or equal to 24 weeks, For all end points, individual trial results were similar to the results of the combined analysis. Anastrozole and megestrol acetate were well tolerated. Gastrointestinal disturbance was more common among patients in the anastrozole groups than the megestrol acetate group; the difference between the anastrozole 10 mg and megestrol acetate groups was significant (P = .005). Significantly fewer patients in the anastrozole 1-mg (P < .0001) and 10-mg (P < .002) groups had weight gain than in the megestrol acetate group, More than 30% of megestrol acetate-treated patients had weight gain greater than or equal to 5%, and 10% of patients held weight gain greater than or equal to 10%. Patients who received megestrol acetate continued to gain weight over time.Conclusion: Anastrozole, 1 and 10 mg once daily, is well tolerated and as effective as megestrol acetate in the treatment of postmenopausal women with advanced breast cancer who progressed following tamoxifen treatment. Moreover, anastrozole therapy avoids the weight gain associated with megestrol acetate treatment.