Gershanovich M, Chaudri H A, Campos D, Lurie H, Bonaventura A, Jeffrey M, Buzzi F, Bodrogi I, Ludwig H, Reichardt P, O'Higgins N, Romieu G, Friederich P, Lassus M
N. N. Petrov Research Institute of Oncology, St. Petersburg, Russia.
Ann Oncol. 1998 Jun;9(6):639-45. doi: 10.1023/a:1008226721932.
The study compares letrozole and aminoglutethimide (AG), a standard therapy for postmenopausal women with advanced breast cancer, previously treated with antioestrogens.
555 women were randomly assigned letrozole 2.5 mg once daily (n = 185), letrozole 0.5 mg once daily (n = 192) or aminoglutethimide 250 mg twice daily with corticosteroid support (n = 178) in an open-label, multicentre trial. The primary endpoint was objective response rate (ORR), with time events as secondary. ORR was analysed nine months after enrollment of the last patient, while survival was analysed 15 months after the last patient was enrolled. We report the results of these analyses plus an extended period of observation (covering a total duration of approximately 45 months) to determine the duration of response and clinical benefit.
Overall objective response rates (complete + partial) of 19.5%, 16.7% and 12.4% were seen for letrozole 2.5 mg, 0.5 mg and AG respectively. Median duration of response and stable disease was longest for letrozole 2.5 mg (21 months) compared with letrozole 0.5 mg (18 months) and AG (14 months). Letrozole 2.5 mg was superior to AG in time to progression, time to treatment failure and overall survival. Treatment-related adverse events occurred in fewer patients on letrozole (33%) than on AG (46%). Transient nausea was the most frequent event with letrozole (7% on 0.5 mg, 10% on 2.5 mg, 10% on AG), rash with AG (11%, 1% on 0.5 mg, 3% on 2.5 mg letrozole).
Letrozole 2.5 mg offers longer disease control than aminoglutethimide and letrozole 0.5 mg in the treatment of postmenopausal women with advanced breast cancer, previously treated with anti-oestrogens.
本研究比较来曲唑与氨鲁米特（AG），AG是绝经后晚期乳腺癌女性患者先前接受抗雌激素治疗后的标准疗法。
在一项开放标签、多中心试验中，555名女性被随机分配接受每日一次2.5毫克来曲唑治疗（n = 185）、每日一次0.5毫克来曲唑治疗（n = 192）或每日两次250毫克氨鲁米特并给予皮质类固醇支持治疗（n = 178）。主要终点为客观缓解率（ORR），时间事件作为次要终点。在最后一名患者入组九个月后分析ORR，在最后一名患者入组15个月后分析生存率。我们报告这些分析结果以及延长的观察期（总时长约45个月）以确定缓解持续时间和临床获益情况。
来曲唑2.5毫克组、0.5毫克组和AG组的总体客观缓解率（完全缓解 + 部分缓解）分别为19.5%、16.7%和12.4%。来曲唑2.5毫克组的缓解持续时间和疾病稳定时间中位数最长（21个月），而来曲唑0.5毫克组为18个月，AG组为14个月。来曲唑2.5毫克组在疾病进展时间、治疗失败时间和总生存期方面优于AG组。来曲唑治疗的患者中发生治疗相关不良事件的人数（33%）少于AG组（46%）。短暂性恶心是来曲唑最常见的事件（0.5毫克组为7%，2.5毫克组为10%，AG组为10%），皮疹是AG组最常见的事件（11%，来曲唑组0.5毫克组为1%，2.5毫克组为3%）。
在治疗先前接受抗雌激素治疗的绝经后晚期乳腺癌女性患者时，2.5毫克来曲唑比氨鲁米特和0.5毫克来曲唑能提供更长时间的疾病控制。
