Aichi Cancer Center Hospital, Aichi, Japan.
Breast Cancer Res Treat. 2013 Jun;139(2):441-51. doi: 10.1007/s10549-013-2573-3. Epub 2013 May 30.
The aromatase inhibitors exemestane and anastrozole are approved in Japan for first-line treatment of postmenopausal patients with advanced, hormone-receptor-positive breast cancer. This phase 3, randomized, double-blind study directly compared time to progression (TTP) for exemestane and anastrozole therapy in this patient population. Eligible patients were randomized to receive exemestane 25 mg or anastrozole 1 mg, each once daily. The primary endpoint was TTP based on assessment by an expert radiologic images review committee (ERIRC). Secondary endpoints included investigator-assessed TTP, time to treatment failure, overall survival, objective response rate, clinical benefit rate, and safety. A total 298 patients were randomized to receive exemestane (n = 149; mean age 63.4 years) or anastrozole (n = 149; mean age 64.0 years). Median ERIRC-assessed TTP was 13.8 and 11.1 months (hazard ratio = 1.007; 95 % confidence interval [CI]: 0.771, 1.317) and median investigator-assessed TTP was 13.8 and 13.7 months (hazard ratio = 1.059; 95 % CI: 0.816, 1.374) in the exemestane and anastrozole arms, respectively. Median overall survival was 60.1 months in the anastrozole arm and was not reached in the exemestane arm at data cutoff. The objective response rate was 43.9 % (95 % CI: 35.3, 52.8) and 39.1 % (95 % CI: 30.6, 48.1) in the exemestane and anastrozole arms, respectively. Treatment-related adverse events grade ≥3 occurred in 9.4 and 6.0 % of patients, and treatment-related serious adverse events occurred in 4.0 and 3.4 % of patients in the exemestane and anastrozole arms, respectively. In this study, the efficacy and safety profiles of exemestane were similar to those of anastrozole in Japanese patients with advanced, hormone-receptor-positive breast cancer; however, TTP non-inferiority of exemestane versus anastrozole was not confirmed.
在日本，芳香化酶抑制剂依西美坦和阿那曲唑被批准用于治疗绝经后激素受体阳性的晚期乳腺癌患者的一线治疗。这项 3 期、随机、双盲研究直接比较了依西美坦和阿那曲唑治疗这一患者人群的无进展生存期（TTP）。符合条件的患者被随机分配接受依西美坦 25mg 或阿那曲唑 1mg，每日一次。主要终点是由专家放射影像评估委员会（ERIRC）评估的 TTP。次要终点包括研究者评估的 TTP、治疗失败时间、总生存期、客观缓解率、临床获益率和安全性。共 298 例患者被随机分配接受依西美坦（n=149；平均年龄 63.4 岁）或阿那曲唑（n=149；平均年龄 64.0 岁）。ERIRC 评估的中位 TTP 分别为 13.8 和 11.1 个月（风险比=1.007；95%置信区间[CI]：0.771，1.317）和中位研究者评估的 TTP 分别为 13.8 和 13.7 个月（风险比=1.059；95%CI：0.816，1.374）在依西美坦和阿那曲唑组。阿那曲唑组的中位总生存期为 60.1 个月，而依西美坦组在数据截止时未达到。客观缓解率分别为 43.9%（95%CI：35.3，52.8）和 39.1%（95%CI：30.6，48.1）在依西美坦和阿那曲唑组。≥3 级治疗相关不良事件发生在 9.4%和 6.0%的患者中，在依西美坦和阿那曲唑组中，分别有 4.0%和 3.4%的患者发生治疗相关严重不良事件。在这项研究中，依西美坦在日本晚期激素受体阳性乳腺癌患者中的疗效和安全性与阿那曲唑相似；然而，依西美坦与阿那曲唑相比的 TTP 非劣效性未得到证实。
