脂质体紫杉醇联合卡铂与紫杉醇联合卡铂一线治疗晚期非小细胞肺癌的疗效和安全性的比较

Comparison of Efficacy and Safety between Liposome-paclitaxel Injection plus Carboplatin and Paclitaxel plus Carboplatin as First Line Treatment in Advanced Non-small Cell Lung Cancer

目的比较脂质体紫杉醇联合卡铂与紫杉醇联合卡铂一线治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性。方法 54例初治的晚期NSCLC患者随机分为两组,每组27例,分别给予脂质体紫杉醇(175 mg/m2)+卡铂AUC5方案(试验组)和紫杉醇注射液(175 mg/m2)+卡铂AUC5方案(对照组)化疗,两组化疗周期均为21 d,均不少于2周期。化疗2周期后,比较两组患者的疗效和不良反应。结果试验组和对照组在治疗总有效率(显效+有效)(44.4%比33.3%,P=0.577)、骨髓抑制发生率(81.5%比63.0%,P=0.080)、胃肠道反应发生率(96.3%比77.8%,P=0.100)和肿瘤中位进展时间(6个月比5个月,P=0.420)方面差异均无统计学意义。试验组的过敏反应发生率为0,明显低于对照组的11.1%(P=0.000)。结论脂质体紫杉醇联合卡铂与紫杉醇联合卡铂方案一线治疗晚期NSCLC的疗效相当,但过敏反应发生率明显低于紫杉醇联合卡铂方案。

Objective To compare the efficacy and safaty between liposome-paclitaxel plus carboplatin （LPC） and paclitaxel plus carboplatin （PC） as first-line treatment for advanced non-small cell lung cancer （NSCLC）.Methods Totally 54 chemotherapy-naive NSCLC patients were equally and randomly assigned into LPC group and PC group.Liposome-paclitaxel was injected on D1 at a dosage of 175 mg/m2 ; the same dose and administration with paclitaxel injection in the PC group for a maximum of 2 cycles.The efficacy and adverse reactions after 2 cycles of chemotherapy were compared between these two groups.Results The overall response rate （CR ＋ PR） was 44.4％ in the LPC group and 33.3％ in the PC group after 2 cycles of chemotherapy respectively （P =0.577）.In the LPC group and PC group,the incidences of myelodepression was 81.5％ and 63.0％,respectively （P =0.080）,gastrointestinal toxicity was 96.3％ and 77.8％ respectively （P =0.100）,and allergic reactions was 0 and 11.1％,respectively （P =0.000）.The median time to progression was 6 months and 5 months,respectively （P =0.420）.Conclusion LPC group has the same efficacy with PC group and less adverse reactions than PC group.