Double-blind, Randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: Results of a North American trial
Double-blind, Randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: Results of a North American trial
复制标题
DOI：
10.1200/jco.2002.10.058
复制
发表时间：
2002-08-15
影响因子：
45.3
通讯作者：
Buzdar, A
中科院分区：
文献类型：
--
作者：
Osborne, CK;Pippen, J;Buzdar, A
目的：比较氟维司群的疗效和耐受性（以前的ICI 182，780）与阿那曲唑在治疗晚期乳腺癌患者中的应用，所述晚期乳腺癌患者的疾病在先前的内分泌治疗中进展。在这项双盲、双模拟、平行组研究中，绝经后患者随机接受氟维司群250 mg肌肉注射，每月一次，或每日口服阿那曲唑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，反应持续时间（DOR），和tolerability.Results：患者（n = 400）进行了为期16.8个月的中位数。在TTP方面，氟维司群与阿那曲唑同样有效（风险比，0.92; 95.14%置信区间[CI]，0.74 - 1.14; P = 0.43）;氟维司群的中位TTP为5.4个月，阿那曲唑为3.4个月。两种治疗的OR率均为17.5%。氟维司群的临床获益率（完全缓解+部分缓解+病情稳定≥ 24周）为42.2%，阿那曲唑为36.1%（95% CI，-4.00%至16.41%，P = 0.26）。在缓解患者中，氟维司群的中位DOR（从随机化至进展）为19.0个月，阿那曲唑为10.8个月。在所有患者中，氟维司群的DOR显著大于阿那曲唑，平均缓解持续时间的比值为1.35（95%CI，1.10 - 1.67; P < 0.01）。两种治疗均耐受良好。结论：氟维司群至少与阿那曲唑一样有效，疗效终点略优于氟维司群。氟维司群代表了接受托莫西芬治疗后疾病进展的绝经后晚期乳腺癌女性的额外治疗选择。(C)2002年，美国临床肿瘤学会。
Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment.Patients and Methods: in this double-blind, double-dummy, parallel-group study, postmenopausal patients were randomized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rate, duration of response (DOR), and tolerability.Results: Patients (n = 400) were followed for a median period of 16.8 months. Fulvestrant was as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14% confidence interval [CI], 0.74 to 1.14; P = .43); median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole. OR rates were 17.5% with both treatments. Clinical benefit rates (complete response + partial response + stable disease greater than or equal to 24 weeks) were 42.2% for fulvestrant and 36.1% for anastrozole (95% CI, -4.00% to 16.41%, P = .26). In responding patients, median DOR (from randomization to progression) was 19.0 months for fulvestrant and 10.8 months for anastrozole. Using all patients, DOR was significantly greater for fulvestrant compared with anastrozole, the ratio of average response durations was 1.35 (95% CI, 1.10 to 1.67; P < 0.01). Both treatments were well tolerated.Conclusion: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant. Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tomoxifen therapy. (C) 2002 by American Society of Clinical Oncology.