吉西他滨联合顺铂与吉西他滨联合诺维本治疗晚期非小细胞肺癌的临床研究

Gemcitabine plus Cisplatin versus Gemcitabine plus Vinorelbine in Treatment of Advanced Non-small Cell Lung Cancer (NSCLC)

背景与目的:含铂联合方案虽然已成为治疗非小细胞肺癌的标准方案,但其严重的毒副反应促使人们寻找新的代替方案。本研究拟观察比较吉西他滨联合顺铂(GP方案)与吉西他滨联合诺维本(GN方案)治疗晚期非小细胞肺癌的疗效,生存率及毒副反应。方法:对82例经病理或细胞学证实的晚期非小细胞肺癌的初治或手术、放疗后患者给予联合化疗,随机分为GP组或GN组。GP方案组42例,GN方案组40例,两组病例具有可比性。GP组吉西他滨1000mg/m2,静脉滴注,d1、8,顺铂80mg/m2,静脉滴注d1,GN组吉西他滨1000mg/m2静脉滴注,d1、8,诺维本25mg/m2,静脉推注d1、8。21天为1个疗程。每例病人治疗2个疗程以上。结果:GP组总有效率(PR+CR)为28.6%,1年生存率为64%,中位生存期8.78个月;GN组总有效率(PR+CR)25%,1年生存率66%,中位生存期9.87个月。两组间有效率、1年生存率比较差异无显著性。最常见的毒副反应为恶心,呕吐,GP组和GN组的3～4度反应发生率分别为52.38%和2.5%,差别有统计学意义(P=0.0005)。其余毒副反应轻微,可耐受。结论:吉西他滨联合顺铂与吉西他滨联合诺维本相比,疗效相似,非铂类方案的毒副反应小于含铂类方案。

BACKGROUND &OBJECTIVE: Although platin-based chemotherapy has b ec ome a standard treatment for non-small cell lung cancer (NSCLC),its severe toxi cities limit clinical application,and a new replacement is required. The study w as to evaluate the efficacy,survival rate and toxicity between the combination o f gemcitabine and cisplatin(GP arm) and the combination of gemcitabine and vinor elbine (GN arm) in the treatment of advanced NSCLC. METHODS: Eighty-two patient s with locally advanced or metastatic NSCLC were enrolled into this study. 42 pa tients and 40 patients were randomized into GP group and GN group respectively. The patientscharacteristics were similar between the two groups. They were tre ated with gemcitabine (1 000 mg/m2 d1,d8) plus cisplatin (80 mg/m2,d1) in GP gro up,or gemcitabine plus vinorelbine (25 mg/m2 d1,d8) in GN group. The chemotherap y was repeated every 3 weeks as a cycle. Every patient was treated two cycles at least. RESULTS: An objective response rate of 28.6%was observed in GP arm vers us 25%in GN arm (P=0.346). The 1-year survival rate was 64%in GP arm and 66% in GN arm. The median survival time was 9.87 months for GN arm and 8.78 months f or GP arm. Nausea and vomiting were the major dose-limiting toxicity. The incid ence of grade Ⅲ/Ⅳnausea and vomiting was significantly higher in the GP arm th an in the GN arm (P=0.000). The Leukopenia incidence was similar in two groups(P =0.130).CONCLUSION: The efficacy of GN regimen (platinum-free regimen) was simi lar to that of GP regimen,but the toxicity of GN regimen is lighter than that of GP regimen.