来曲唑与氨鲁米特对照治疗绝经后晚期乳腺癌113例

目的 对比来曲唑和氨鲁米特治疗妇女绝经后晚期乳腺癌患者的有效性和耐受性。 方法 采用开放、随机、多中心对照研究。患者随机分组接受口服来曲唑2．5mg．d-1或氨鲁米特1g．d-1的对照治疗。 结果 来曲唑组(n=59)有效率23．73％(CR 2例，PR 12例，ITT有效率21．88％)，SD 20．31％(13例)。氨鲁米特组(n=54)有效 率11．11％(CR 1例，PR 5例，ITT有效率10．17％)，SD 20．34％(12例)，2组疗效无统计学差异(P>0．05)。来曲唑组和氨鲁米特 组不良反应发生率分别为18．64％和42．11％，与治疗相关的不良反应发生率分别为13．56％和33．33％。比较2组总的和与治疗 相关的不良反应发生率均以来曲唑组明显较低，P值均为0．002。 结论 来曲唑对绝经后、ER／PR阳性或不明的晚期乳腺癌患者有效率为23．73％，与氨鲁米特比较无统计学差异。但来曲唑不良 反应较氨鲁米特明显低，可以代替氨鲁米特用于晚期绝经后受体阳性或不明乳癌患者的治疗。

Comparison of Letrozole and Aminoglutethimide in Treatment of 113 Cases of Postmenopausal Women with Advanced Breast Cancer

Objective: To compare the efficacy and tolerability of letrozole with aminoglutethimide (AG) in postmenopausal women with advanced breast cancer. Methods: The multicenter, randomized controlled clinical trial was conducted in 113 patients. They randomly received letrozole 2.5 mg once daily (letrozole group) or AG 250 mg 4 times daily (AG group) with hydrocortisone. Results: The OR in letrozole group was 23.73% (2 cases of CR and 12 cases of PR, ITT OR was 21.88%), which was higher than in AG group (the OR 11.11%, 1 CASE of CR and 5 cases of PR, ITT 10.17%), but there was no statistically significant difference (P>0.05). Adverse events (AE) and the treatment related AE (RAE) in letrozole group (n=59) was 18.54% and 13.56% respectively, significantly lower than those (42.11% and 33.33% respectively) in AG group (n=57, P=0.002). Conclusion: The OR of letrozole in the treatment of postmenopausal advanced breast cancer positive or unknown for hormonal receptor is 23.73%, showing no significant difference to that of AG. The AE of letrozole are significantly less than AG.