弗隆和氨鲁米特治疗绝经后妇女晚期乳腺癌临床观察(英文)

目的观察弗隆和氨鲁米特治疗绝经后晚期乳腺癌的疗效和不良反应。方法 50例绝经后晚期乳腺癌患者随机进入弗隆组26例和氨鲁米特组24例。弗隆2.5mg 口服,每天1次。氨鲁米特,第1周125mg 口服,每日2次;第2周,250mg,每日2次;第3周250mg,每日3次;从第4周开始,250mg,每日4次。治疗30天为1周期。结果弗隆组有效患者(CR+PR)7例(26.9%),高于氨鲁米特组3例(12.5%),但差异无显著性(P=0.294)。两组病情稳定(SD)患者分别有14例(53.8%)和12例(50.0%);病情进展(PD)患者分别有5例(19.2%)和9例(37.5%)。两药疗效在不同受体状态、无病间期、病变部位和治疗阶段的分层比较,差异均无显著性(P 值均>0.05)。弗隆组主要的不良反应有乏力(15.4%),食欲下降(11.5%)、头晕、恶心、头痛、嗜睡发生率均<8%,且程度较轻;氦鲁米特组恶心(25.0%)、呕吐(16.7%)发生明显高于弗隆组,差异有显著性(P 值分别为0.045和0.046),头晕(25.0%)、乏力(20.8%)、食欲下降(16.7%)、嗜睡(12.5%)、皮肤瘙痒(12.5%)的发生也均高于弗隆组,但差异无显著性(P 值均>0.05),另外有1例患者出现过敏性皮疹。结论弗隆治疗绝经后晚期乳腺癌有一定疗效,部分不良反应比氨鲁米特轻,患者耐受性强。

Clinical Trial of Letrozole (femara) versus Aminoglutethimide in Postmenopausal Women with Advanced Breast Cancer

Objective:To compare the response and adverse reactions of aminoglutethimide with that of femara,an oral aromatase inhibitor,in postmenopausal women with advanced breast,cancer.Methods: Fifty patients were randomly assigned to femara 2.5 mg once daily(n=26)or aminoglutethimide(n=24) 125 mg twice daily in the first week,250 mg twice daily in the second week,250 mg three times daily in the third week and 250 mg four times daily in the fourth week,30 days for one cycle for both groups. Results:Overall objective response rate(complete+partial)of 26.9% for femara was 12.5% higher than that of aminoglutethimide,but there was no significant difference(P=0.294).The percentages of stable disease were 53.8% and 50.0% respectively in both treatment groups and that of progressive disease of two groups were 19.2% and 37.5%.There was no significant difference between two arms in the receptor status. disease-free intervals,sites of disease and stages of treatment.Femara-related adverse events were fatigue (15.4%),anorexia(11.5%),dizziness(7.7%),nausea(3.8%)and somnolence(3.8%).However,incidence of nausea(25.0%)and vomiting(16.7%)in aminoglutethimide group was obviously higher and severer than that in femara group(P=0.045 and P=0.046).Compared to femara group,frequency in dizziness (25.0%),fatigue(20.8%),anorexia(16.7%),somnolence(12.5%)and cutaneous pruritus(12.5%)was higher in aminoglutethimide group.Allergic rash occurred in aminoglutethimide group.Conclusion:Femara was more effective and well tolerated than aminoglutethimide with respect to side effects in the treatment of postmenopausal women with advanced breast cancer.