Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment
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DOI：
10.1200/jco.2002.10.057
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发表时间：
2002-08-15
影响因子：
45.3
通讯作者：
Morris, C
中科院分区：
文献类型：
--
作者：
Howell, A;Robertson, JFR;Morris, C
目的：比较氟维司群的疗效和耐受性（以前的ICI 182，780）和阿那曲唑在绝经后妇女中的应用。晚期乳腺癌患者（n = 451）随机接受氟维司群250 mg，每月一次，（1 x 5 mL）肌肉注射或口服阿那曲唑1 mg。主要终点是疾病进展时间（TTP）。次要终点包括客观反应（OR）率，定义为完全反应（CR）或部分反应（PR），反应持续时间（DOR），和tolerability.Results：患者随访的中位数为14.4个月。在TTP方面，氟维司群与阿那曲唑一样有效（风险比，0.98;置信区间[CI]，0.80 - 1.21; P = 0.84）。氟维司群的中位TTP为5.5个月，阿那曲唑为5.1个月。氟维司群的OR率（20.7%）优于阿那曲唑（15.7%）（比值比，1.38; CI，0.84 - 2.29，P = 0.20）。氟维司群的临床获益率（CR + PR +病情稳定≥ 24周）为44.6%，阿那曲唑为45.0%。氟维司群的中位DOR为15.0个月，阿那曲唑为14.5个月。两种治疗耐受性良好，分别有3.2%和1.3%的氟维司群和阿那曲唑治疗的患者，退出治疗，因为不良事件。结论：氟维司群是有效的阿那曲唑。这些数据证实，氟维司群是一种额外的，有效的，耐受性良好的治疗晚期乳腺癌的绝经后妇女的疾病进展的先前内分泌治疗。(C)2002年，美国临床肿瘤学会。
Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.Patients and Methods: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability.Results: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P = .84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29, P = .20). Clinical benefit rates (CR + PR + stable disease greater than or equal to 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 15.0 months for fulvestrant and 14.5 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event.Conclusion: Fulvestrant was as effective as anastrozole. These data confirm that fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy. (C) 2002 by American Society of Clinical Oncology.