GP和TP方案治疗晚期非小细胞肺癌的随机对照临床研究

Randomized clinical trial of paclitaxel plus cisplatin versus gemcitabine plus cisplatin in the treatment of patients with advanced non-small cell lung cancer

背景与目的 目前铂类药物为基础的化疗被认为是治疗晚期非小细胞肺癌（NSCI．C）的标准方案。本研究的目的是比较紫杉醇联合顺铂（TP方案）与吉西他滨联合顺铂（GP方案）治疗晚期NSCLC的近期疗效和毒性作用。方法 77例初治晚期NSCLC患者随机分为TP组和GP组，TP组39例，GP组38例。TP组：紫杉醇135mg／m^2，第1天；顺铂30mg／m^2，第1～3天。GP组：吉西他滨1000mg／m^2，第1、8天；顺铂30mg／m^2，第1～3天。化疗2～3周期后对两组的临床疗效和毒性反应进行评价。结果 TP组有效率为46．2％，GP组为42．1％，两组间比较差异无统计学意义（P〉0．05）。GP组不良反应以血小板降低为主，TP组以白细胞降低为主，均可耐受。结论 吉西他滨或紫杉醇联合顺铂治疗晚期NSCLC具有较好的耐受性和临床疗效，不良反应有所不同，但都可以耐受。

Background and objective Cisplatin-based chemotherapy is the standard regimens in the treatment of advanced non-small cell lung cancer （NSCLC）. The aim of this trial is to evaluate the efficacy and toxicity of paclitaxel or gemcitabine combined with cisphin for patients with advanced NSCLC. Methods Seventy-seven advanced NSCLC patients were randomly divided into 2 groups, 39 in TP group and 38 in GP group. TP group： paclitaxel 135 mg/m^2 , on day 1;cisplatin 30 mg/m^2 , on days 1-3. GP group： gemcitabine 1000 mg/m^2 , on days 1, 8; cisplatin 30 mg/m^2 , on days 1-3. Results Patients＇ characteristics were similar between the two groups. The overall response rate was 46.2% in the TP group and 42.1% in the GP group. There was no statistically significant difference in response rate between the two groups （P〉0.05）. The major cytotoxicity was leukopenia in the TP group and thrombocytopenia in the GP group. Conclusion Both TP and GP regimens are effective {or advanced NSCLC and have no significant difference. The side effects of the two regimens are different but all adverse reactions are tolerable.