Bonneterre J, Thürlimann B, Robertson J F, Krzakowski M, Mauriac L, Koralewski P, Vergote I, Webster A, Steinberg M, von Euler M
Centre Oscar Lambret, Lille, France.
J Clin Oncol. 2000 Nov 15;18(22):3748-57. doi: 10.1200/JCO.2000.18.22.3748.
To compare the efficacy and tolerability of anastrozole (Arimidex; AstraZeneca, Wilmington, DE, and Macclesfield, United Kingdom) with that of tamoxifen as first-line therapy for advanced breast cancer (ABC) in postmenopausal women.
This randomized, double-blind, multicenter study evaluated the efficacy of anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with tumors that were hormone receptor-positive or of unknown receptor status who were eligible for endocrine therapy. The primary end points were time to progression (TTP), objective response (OR), and tolerability.
A total of 668 patients (340 in the anastrozole arm and 328 in the tamoxifen arm) were randomized to treatment and followed-up for a median of 19 months. Median TTP was similar for both treatments (8.2 months in patients who received anastrozole and 8.3 months in patients who received tamoxifen). The tamoxifen:anastrozole hazards ratio was 0.99 (lower one-sided 95% confidence limit, 0.86), demonstrating that anastrozole was at least equivalent to tamoxifen. Anastrozole was also as effective as tamoxifen in terms of OR (32.9% of anastrozole and 32.6% of tamoxifen patients achieved a complete response [CR] or partial response [PR]). Clinical benefit (CR + PR + stabilization of > or = 24 weeks) rates were 56.2% and 55.5% for patients receiving anastrozole and tamoxifen, respectively. Both treatments were well tolerated. However, incidences of thromboembolic events and vaginal bleeding were reported in fewer patients treated with anastrozole than with tamoxifen (4.8% v 7.3% [thromboembolic events] and 1.2% v 2.4% [vaginal bleeding], respectively).
Anastrozole satisfied the predefined criteria for equivalence to tamoxifen. Together with the lower observed incidence of thromboembolic events and vaginal bleeding, these findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with ABC.
比较阿那曲唑（瑞宁得；阿斯利康公司，美国特拉华州威尔明顿市和英国麦克尔斯菲尔德市）与他莫昔芬作为绝经后女性晚期乳腺癌（ABC）一线治疗药物的疗效和耐受性。
这项随机、双盲、多中心研究评估了对于适合内分泌治疗的激素受体阳性或受体状态未知的肿瘤患者，每日一次服用1毫克阿那曲唑相对于每日一次服用20毫克他莫昔芬的疗效。主要终点为疾病进展时间（TTP）、客观缓解率（OR）和耐受性。
共有668例患者（阿那曲唑组340例，他莫昔芬组328例）被随机分配接受治疗，中位随访时间为19个月。两种治疗的中位TTP相似（接受阿那曲唑治疗的患者为8.2个月，接受他莫昔芬治疗的患者为8.3个月）。他莫昔芬与阿那曲唑的风险比为0.99（单侧95%置信下限为0.86），表明阿那曲唑至少与他莫昔芬等效。在OR方面，阿那曲唑与他莫昔芬同样有效（阿那曲唑组32.9%的患者和他莫昔芬组32.6%的患者达到完全缓解[CR]或部分缓解[PR]）。接受阿那曲唑和他莫昔芬治疗的患者的临床获益率（CR + PR + 病情稳定≥24周）分别为56.2%和55.5%。两种治疗的耐受性均良好。然而，与他莫昔芬治疗的患者相比，接受阿那曲唑治疗的患者报告的血栓栓塞事件和阴道出血发生率较低（分别为4.8%对7.3%[血栓栓塞事件]和1.2%对2.4%[阴道出血]）。
阿那曲唑符合与他莫昔芬等效的预定义标准。连同观察到的较低的血栓栓塞事件和阴道出血发生率，这些发现表明阿那曲唑应被视为绝经后ABC女性的一线治疗药物。
