弗隆和氨鲁米特治疗绝经后妇女晚期乳腺癌临床观察  

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

作　　者：刘晓晴[1] 宋三泰[1] 江泽飞[1] 李维廉[2] 吴世凯[1] 杨丽芳[1] 于静新[1] 

机构地区：[1]军事医学科学院附属307医院,北京市100039 [2]天津市第二中心医院

出　　处：《中国肿瘤临床》2004年第7期384-386,共3页Chinese Journal of Clinical Oncology

摘　　要：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;氨鲁米特组恶心(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。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 2.5mg once daily (n=26) or aminoglutethimide (n=24) 125mg twice daily in the first week, 250mg twice daily in the second week, 250mg tri daily in the third week, 250mg quadri daily in the fourth week, thirty days for one cycle. Results: Overall objective response rate (complete+partial) of 26.9% for femara was higher than 12.5% for aminoglutethimide, but there was no significant difference (P=0.294). Stable disease were 53.8% and 50.0%, respectively, in both treatment groups. Progressive disease were 19.2% and 37.5%. There were 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%), headache (3.8%) and somnolence (3.8%). Nausea (25.0%) and vomiting (16.7%) in aminoglutethimide were obviously higher and severer than femara (P=0.045 and P=0.046 ). Dizziness (25.0%), fatigue (20.8%), anorexia (16.7%), somnolence (12.5%) and cutaneous pruritus (12.5%) were more frequent, and allergic rash occurred in one patient with aminoglutethimide. Conclusion: Femara was effective and well tolerated than aminoglutethimide with respect to side effects in the treatment of postmenopausal women with advanced breast cancer.

关 键 词：乳腺肿瘤 内分泌治疗 弗隆 氨鲁米特 

分 类 号：R737.9[医药卫生—肿瘤]