不同剂量顺铂联合长春瑞滨治疗老年晚期非小细胞肺癌对照研究

A study comparing two different doses of cisplatin plus vinorelbine in the treatment of the elderly patients with advanced non-small lung cancer

目的对照研究低剂量与常规剂量顺铂（cisplatin、DDP）联合长春瑞滨（vinorelbine、NVB）对老年晚期非小细胞肺癌（non-small cell lung cancer、NSCLC）的近、远期疗效及毒性反应，进一步探讨顺铂在老年晚期NSCLC中的最低有效剂量。方法低剂量组：NVB 25mg／m^2,静脉点滴，第1、8天，顺铂40mg／m^2,静脉点滴，第1天或第1～2天；常规剂量组：NVB 25mg／m^2，静脉点滴，第1、8天，顺铂70mg／m^2 d1或d1～2。3周为一周期，完成四周期后进行评定疗效。结果入组病例61例，低剂量组和常规剂量组各32例和29例，用药后均可评价疗效，两组的有效率（RR）分别为31．3％和44．8％，近期疗效差异无统计学意义；两组的中位生存期（median survive times、MST）分别为41周和46周，一年生存率分别为36％和38％，远期疗效差异亦无统计学意义。毒性反应方面，低剂量顺铂组Ⅲ～Ⅳ度白细胞减少、恶心呕吐发生率分别为4（12．5％）、1（3．1%），常规剂量组Ⅲ～Ⅳ度自细胞减少、恶心呕吐发生率分别为13（44．8％）、8（27．8％），差异有统计学意义。其余毒性反应较轻，无化疗相关死亡。结论低剂量顺铂联合长春瑞滨对老年晚期NSCLC的疗效与常规剂量组相似，毒性反应轻，特别适合老年晚期NSCLC患者使用；老年晚期NSCLC的联合化疗中顺铂40mg／m^2为有效剂量。

Objective： To compare efficacy and tolerance of elderly advanced non-small cell lung cancer （NSCLC） treated by two different doses of cisplatin plus vinorelbine, to further assess the effective dose intensity of cisplatin in combined chemotherapy. Methods： Treatment was divided for chemotherapy between two courses of low dose group or routine dose group. the low dose group： vinorelbine 25mg/m^2, iv infusion, d1、d8, cisplatin40 mg/m^2, iv infusion, d1 or d1-2; the routine dose group： vinorelbine 25mg/m^2, iv infusion, d1、d8, cisplatin70 mg/m^2, iv infusion, d1 or d1-2. repeated every 3 weeks. efficacy was evaluated at 4 cycles. Result： Sixty one patients were entered onto the study, all of whom were eligible, There were 31.3% and 44.8% clinical respone rate （RR） in two groups respectively, There was no statistically significant difference in RR between two arms; Median survive times （MST） was 41weeks in the first group and 46weeks in the second group, one-year survival rate was 36% and 38% respectively, There was no statistically significant difference in MST between two arms. All patients were evaluable for toxicity, WHO grades 3/4 neutropenia, nausea and vomiting occurred in four （12.5%）, one patient （3.1%） in the first group, and in thirteen （44.8%）, eight patients （27.8%） in the second group, respectively, There was statistically significant differenee in toxicity between two arms. Other toxieities were mild and few, There was no treatment-related deaths. Conclusion： The combination of low dose intensity of cisplatin and vinorelbine, being well-treatment, should be taken as an energetic scheme in the treatment of elderly advanced NSCLC, toxieities were mild. Cisplatin 40 mg/m^2 is an effieetive dose intensity in combined chemotherapy of elderly advanced NSCLC.