多西紫杉醇联合顺铂与紫杉醇联合顺铂一线治疗晚期非小细胞肺癌的随机临床对照研究

A Randomized Study Comparing Docetaxel plus Cisplatin versus Paclitaxel plus Cisplatin as a First-Line Chemotherapy for Previously Untreated Advanced Non-Small Cell Lung Cancer

背景与目的 多西紫杉醇是二线治疗晚期非小细胞肺癌的有效药物，近年来多项临床试验显示其在一线治疗晚期非小细胞肺癌的疗效与目前常用的一线方案相似。本研究拟比较多西紫杉醇联合顺铂（DC）与紫杉醇联合顺铂（PC）一线治疗晚期非小细胞肺癌的疗效、毒副反应及生存。方法细胞学或病理学确诊的90例初治晚期非小细胞肺癌患者随机分为DC组与PC组。DC组：多西紫杉醇75mg／m^2，静脉滴注1小时，第1天，顺铂75mg／m^2，分成两天静脉滴注，第2，3天。PC组：紫杉醇150mg／m^2，静脉滴注3小时，第1天；顺铂75mg／m^2，分成两天静脉滴注，第2～3天。顺铂用药时需水化。两种方案均为21天重复。至少完成2周期化疗的患者进行疗效、毒副反应评价，并分析生存情况。结果DC组总有效率为31．1％，中位生存期为10．2月，中位疾病进展时间为4．4月，1年和2年生存率分别为35．6％、8．9％；PC组总有效率为33．3％，中位生存期为10．4月，中位疾病进展时间为4．9月，1年和2年生存率分别为37．8％、11．1％。两组的总有效率、中位生存期、中位疾病进展时间及1、2年生存率均无显著性统计学差异（P〉0．05）。两组Ⅲ度和Ⅳ度毒副反应为白细胞减少、贫血、恶心呕吐及脱发，无显著性统计学差异（P〉0．05）。结论多西紫杉醇联合顺铂方案与紫杉醇联合顺铂方案比较，疗效与生存相似，毒副反应较轻，耐受性好，是一线治疗非小细胞肺癌的有效方案。

Background and objective Docetaxel is effective in second-line medicine for non-small cell lung cancer（NSCLC）, varied clinical trials have demonstrated that it has similar efficacy to cormnon first-line regimens for NSCLC. We conducted a ran-domized study to compare docetaxel plus cisplatin （DC） versus paclitaxel plus cisplatin （PC） for patients with advanced non-small cell lung cancer as the first-line regimen, and evaluated its effects and safety. Methods Ninety patients with previously untreated advanced non-small cell lung cancer were randomly assigned to receive either DC or PC. Patients received docetaxel 75 mg/m^2 on day 1 and cisplatin 75 mg/m^2 divided into two doses on d2 to d3 in DC group and paclitaxel 150 mg/m^2 on day 1 and cisplatin 75 mg/m^2 divided into two doses on d 2 to d 3 in PC group. The cycle of two regimens was repeated every 3 weeks. Response and toxicity were evaluated in patients who completed two cycles of chemotherapy at least. Results Overall survival rate was 31.1% in DC group and 33.3 % in PC group. The median survival time was 10.2 months in DC group and 10.4 months in PC group. Median time to tumor progression was 4.4 months in DC group and 4.9 months in PC group. 1- and 2-year survival rate were 35.6% and 8.9% in DC group and 37.8% and 11.1% in PC group respectively. There was no statistical significant differences in response rate, median survival time, median time to tumor progression and survival rate between two groups（P〉0.05）. Leucopenia, anemia, nausea and vomiting, and alopecia were the most commnon grade Ⅲ and Ⅳ toxicities in DC and PC groups, there was no significant differences in grade Ⅲ and Ⅳ toxicittes between two groups （P〉0.05）. There was no treatment-related deaths in both groups. Conclusions DC has similar response rate and survivals with PC, and its toxicity is well-tolerated. Docetaxel plus cisplatin is an effective first-line chemotherapy for patients of NSCLC.