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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。
Background and objective Paclitaxel plus cisplatin (TP) is one of the standard protocols for the first-line treatment of advanced non-small cell lung cancer (NSCLC). This study was designed to compare the short-term efficacy, long-term survival and side effects of paclitaxel liposome combined with cisplatin (liposome pacilitaxelplus cisplatin, LP) and first-line TP regimen in the treatment of advanced NSCLC. Methods One hundred patients were randomly divided into two groups: paclitaxel liposome and paclitaxel 150 mg / m 2 intravenously, on the first day, combined with cisplatin 75 mg / m 2, day 1 -2, day 21 A cycle. Results All 100 patients were eligible for evaluation. The median progression-free survival (PFS) was 5.1 months in LP group and 9.0 months in overall survival. The objective response rate ( response rate (RR) was 26%. The median PFS in TP group was 4.2 months. The median OS was 9.3 months and RR was 24%. There was no significant difference between the two groups (P = 0.110; P = 0.342; P = 0.890). There was no significant difference in grade Ⅲ + Ⅳ toxicity between the two groups (P> 0.05). The incidence of peripheral neuritis in LP group was lower than that in TP group (8% vs 28%, P = 0.030). Conclusion The first-line treatment of advanced NSCLC with LP regimen is equivalent to TP regimen and the incidence of peripheral neuritis is lower than that of TP regimen.