摘要
目的 观察不同多西紫杉醇用法联合卡培他滨治疗葸环类失败复发转移性乳腺癌的疗效和安全性.方法 选择83例蒽环类失败的复发转移性乳腺癌患者,接受多西紫杉醇联合卡培他滨方案治疗,随机分为两组,A组34例：多西紫杉醇37.5 mg/m^2静滴第1、8天;卡培他滨950 ms/m^2口服,2次/d,第1～14天,每3周为1周期;B组49例：多西紫杉醇75 mg/m^2 静滴第1天;卡培他滨950 ms/m^2口服,2次/d,第1～14天,每3周为1周期.每周期评价疗效同时记录不良事件.结果 78例患者可评价疗效,完全缓解（CR）8例,部分缓解（PR）43例,有效率（CR＋PR）61.4%（51/83）.A组有效率61.8%（21/34）,B组有效率61.2%（30/49）,两组差异无统计学意义（P=0.813）.两组共83例患者可评价毒性反应,元严重不良事件导致死亡的患者,粒细胞减少是主要不良反应,Ⅲ/Ⅳ度发生率45.8%（38/83）,两组分别为32.4%（11/34）和55.1%（27/49）（P=0.04）.结论 不同多西紫杉酵用法联合卡培他滨是治疗蒽环类失败复发转移性乳腺癌的有效方案,其不良反应能够耐受,两组疗效相当,周疗组Ⅲ/Ⅳ度粒细胞减少较少.
Objective To evaluate the efficacy and safety of weekly or 3-week docetaxel in combination with capecitabine. Methods 83 Patients with at least one measurable lesion were randomized to receive the treatment arms： docetaxel 37. 5 mg/m^2 on days 1 and 8, oral capecitabine 950 mg/m^2 twice daily on days 1 -14 （Group A） ; docetaxel 75 mg/m^2 on days 1, oral capecitabine 950 mg/m^2 twice daily on days 1-14 （Group B）. Each cycle was repeated every 3 weeks. Results Eighty-three patients were enrolled,78 eligible for tumor assessment. The overall clinical response rate of all groups was 61. 4% （51/83）. There was no progressive disease （PD） after two cycles. Efficacy outcomes were similar in the two groups. The response rate of group A and B were 61.8% （21/34） and 61.2% （30/49） respectively. There were no drug-related deaths observed.Neutropenia was the most common toxicity. In all, the frequence of Grade 3/ 4 neutropenia were 45. 8% （38/83） , but Grade3/ 4 neutropenia of Group B 55. 1% （27/49） was higher than Group A 32. 4% （ 11/34）, P = 0. 04. Conclusion The study confirmed the superior activity of docetaxe-capecitabine combination therapy in anthracycline resistant MBC, and comparing with 3-week schedule, weekly docetaxel plus capecitabine has same high efficacy with a favourable safety profile.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2010年第26期1813-1815,共3页
National Medical Journal of China
