双环铂联合紫杉醇与卡铂联合紫杉醇方案对比治疗初治晚期非小细胞肺癌的Ⅱ期临床研究

A PHASEⅡ MULTICENTER TRIAL OF DICYCLOPLATIN PLUS PACLITAXEL VERSUS CARBOPLATIN PLUS PACLITAXEL IN CHEMOTHERAPY-NAIVE PATIENTS WITH ADVANEED NON-SMALL CELL LUNG CANCER

目的:对比分析卡铂联合紫杉醇方案和双环铂联合紫杉醇方案治疗初治晚期非小细胞肺癌(NSCLC)的疗效和不良反应。方法:本研究为随机对照、开放的Ⅱ期临床研究,符合入组条件的NSCLC患者被随机分入试验组和对照组。试验组的化疗方案为:双环铂450mg/m2+紫杉醇175mg/m2,每3周重复;对照组的化疗方案为:卡铂(AUC=5)+紫杉醇175mg/m2,每3周重复。近期疗效评价按照RECIST标准,不良反应评价按CTCAE v3.0标准,并随访患者的生存情况。结果:本中心初筛入组患者16例,其中合格受试者15例(试验组8例,对照组7例),试验组和对照组的有效率分别为4/8和3/7,中位疾病进展时间分别为4.8个月和5.0个月,中位生存时间分别为10.6个月和13.2个月。两组比较差异均无统计学意义(均P>0.05)。两组的主要不良反应均为骨髓抑制和胃肠道反应,两组不良反应发生率比较差异无统计学意义(P>0.05)。结论:双环铂联合紫杉醇与卡铂联合紫杉醇方案治疗初治晚期NSCLC的疗效和不良反应相似,均安全有效,值得进一步扩大临床研究。

Objective：To investigate the efficacy and toxicity of dicycloplatin plus paclitaxel versus carboplatin plus paclitaxel in chemotherapy-naive patients with advanced non small cell lung cancer （NSCLC）.Methods：It was a randomized,controlled and open phase Ⅱ clinical trial.Patients were randomly assigned to the experimental group （dicycloplatin 450 mg/m2 plus paclitaxel 175 mg/m2,q3w） and control group （carboplatin AUC 5 plus paclitaxel 175 mg/me,q3w）.Efficacy and toxicity were evaluated.Results：Fifteen patients who met the criteria were enrolled in the study （experimental group,n =8;control group,n=7）.The response rate （RR） of the patients was 50.0% in experimental group and 42.9 % in control group.The median time to progress （mTTP） in experimental and control groups was 4.8 and 5.0 months,respectively; and the corresponding median overall survival （mOS） were 10.6 and 13.2 months,respectively.There were no significant differences in RR,mTTP and mOS between the two groups （P 〉0.05）.Myelosuppression and gastrointestinal reactions were similar in both groups.Conclusion：The efficacy and toxicity of dicycloplatin plus paclitaxel and carboplatin plus paclitaxel in patients with advanced NSCLC were comparable.The clinical trial of dicycloplatin is worth further studying.