NP方案与TP方案治疗晚期非小细胞肺癌的临床观察

The Clinical Study of Paclitaxel plus Cisplatin Versus Vinorelbine plus Cisplatin in Treatment of Patients with Advanced Non-Small Cell Lung Cancer

目的评价NP方案与TP方案治疗晚期非小细胞肺癌的疗效和毒副反应。方法NP方案:长春瑞滨(NVB)25mg/m2,静脉推注,第1,8天;顺铂(DDP)75mg/m2,静脉滴注,第1天。TP方案:泰素(PTX)135mg/m2,静脉滴注,第1天,维持3h;DDP75mg/m2,静脉滴注,第2天。21天为1周期。结果分析结果显示:NP组30例,CR1例(3.3%),PR13例(40%),NC12例(40%),总有效率43.3%;TP组29例,CR1例(3.4%),PR12例(41.4%),NC11例(37.9%),总有效率44.8%。NP组和TP组中位缓解时间分别为5.4个月和4.5个月。初治优于复治(NP组为72.7%对31.6%,P=0.0308;TP组为75.0%对33.3%,P=0.0480);Ⅲb期优于Ⅳ期(NP组为77.8%对33.3%,P=0.0288;TP组为85.7%对31.8%,P=0.0176)。剂量限制性毒性主要为骨髓抑制,NP组较TP组稍重,白细胞,血小板减少发生率分别为56.7%,51.7%和33.3%,31.0%。TP组脱发,周围神经毒性较NP组重,而NP组静脉炎及胃肠道反应较TP组重。无IV度反应出现,患者均能够较好地耐受,不影响化疗继续进行。结论NP方案,TP方案治疗晚期非小细胞肺癌安全有效,既可用作一线方案,也可用作二线方案,且二者无明显交叉耐药性,可互为挽救方案。

Objective To evaluate the efficacy and toxicity of Vinorelbine plus Cisplatin(NP) and Paclitaxel plus Cisplatin(TP) combinations in the treatment of advanced non_small cell lung cancer(NSCLC).Methods From Jan 2000 to Dec 2003, 59 patients with advanced NSCLC were randomized to receive Vinorelbine 25 mg/m^2 on 1,8 days by twenty_minute infusion and Cisplatin 75 mg/m^2 on 1 day (group NP),or Paclitaxel 135 mg/m^2 by 3_hour infusion and Cisplatin 75 mg/m^2 on 1 day(group TP).Both regimens were repeated every 3 weeks.Results Of 59 patients(30 patients in group TP,29 patients in group TP)were enrolled. All the characteristics were well matched between the two groups. The median duration of response was 5.4 months for group NP and 4.5 months for group TP. The overall response rate for group NP was 46.6%,with 3.3% complete response(CR),40% partial response(PR),40% stable disease(NC) and 16.7% progression of disease(PD),and in group TP, the overall response rate was 44.8%(CR 3.4%,PR 41.4%,NC 37.9%, and PD 17.3%)( P >0.75).The response rate was higher in grade Ⅲb cases than that in grade Ⅳ cases(77.8% vs 33.3% in group NP, P =0.0288,and 85.7% vs 31.8% in group TP, P =0.0176),higher in previously untreated cases than that in treated cases(72.7% vs 31.6% in group NP, P =0.0308,and 75.0% vs 33.3% in group TP, P =0.048).The incidence of neutropenia and thrombocytopenia were 56.7% and 51.7% in group NP, and 33.3% and 31.0% in group TP. Phlebitis(16.7% vs 3.4%) and nausea/vomiting(43.3% vs 41.4%) were more severe in group NP. By contrast, alopecia (65.6% vs 6.7%) and peripheral neurotoxicity(37.9% vs 33.3%) were more frequent in group TP. The frequency and severity of other toxic reactions were comparable between the two groups. No WHO grade IV toxicity occurred.Conclusions Both NP and TP combined chemotherapy produce the similar efficacy and were well tolerated in the patients with advanced non-small cell lung cancer.