紫杉醇脂质体联合顺铂方案一线治疗晚期非小细胞肺癌的临床随机对照研究

背景与目的紫杉醇联合顺铂方案(pacilitaxel plus cisplatin,TP)是目前一线治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的标准方案之一。本研究旨在比较紫杉醇脂质体联合顺铂(liposome pacilitaxelplus cisplatin,LP)方案与TP方案一线治疗晚期NSCLC的近期疗效、远期生存及毒副反应。方法 100例患者随机分为两组,分别静脉注射紫杉醇脂质体和紫杉醇注射液150 mg/m~2,第1天,联合顺铂75mg/m~2,第1天-2天,21天一个周期。结果 100例患者均可评价疗效,其中LP组中位无进展生存期(progression free survival,PFS)为5.1个月,中位总生存期(overall survival,OS)为9.0个月,客观反应率(response rate,RR)为26%;TP组中位PFS为4.2个月,中位OS为9.3个月,RR为24%;两组比较均无统计学差异(P=0.110;P=0.342;P=0.890)。两组Ⅲ度+Ⅳ度毒性反应均无统计学差异(P>0.05),LP组末梢神经炎发生率低于TP组(8%vs 28%,P=0.030)。结论 LP方案一线治疗晚期NSCLC疗效与TP方案相当,末梢神经炎发生率低于TP方案。

A Randomized Trial of Liposomal Paclitaxel plus Cisplatin as First-line Therapy for Advanced Non-small Cell Lung Cancer

Background and objective Paclitaxel plus cisplatin(TP) is used as the standard regimen for patients with advanced non-small cell lung cancer(NSCLC).In this study,we compared the response rate(RR),overall survival(OS), and toxicity of the combined chemotherapy regimen of liposomal paclitaxel plus cisplatin(LP) with those of TP as first-line treatments for advanced NSCLC.Methods A total of 100 patients were randomly selected to be treated with liposomal paclitaxel or paclitaxel at a dose of 150 mg/m~2 on day 1 plus cisplatin at a dse of 75 mg/m on days 1 and 2 per cycle every 21 days.Results All 100 patients were eligible.The median progression free survival was 5.1 months vs 4.2 months,the median OS was 9.0 months vs 9.3 months,and RR was 26%vs 24%in the LP and TP arms,respectively.No significant difference was observed(P=0.110,0.342 and 0.890,respectively).There was no significant difference between grades 3 and 4 toxicity of the arms(P>0.05).Peripheral neuritis observed in the LP arm was significantly lower than that in the TP arm(8%vs 28%),and the difference was statistically significant(P=0.030).Conclusion The effects of LP and TP as first-line therapies for NSCLC are similar.However,peripheral neuritis in the LP arm is significantly lower than in the TP arm.