长春瑞宾联合顺铂或顺铂/丝裂霉素一线治疗不可手术非小细胞肺癌

A comparative study for vinorelbine with cisplatin plus mitomycin and vinorelbine with cisplatin in advanced non-small-cell lung cancer

目的 比较长春瑞宾联合顺铂和丝裂霉素(MNP)和长春瑞宾联合顺铂(NP)一线治疗晚期非小细胞肺癌(NSCLC)的疗效与安全性。方法 65例经细胞学或病理确诊的NSCLC患者分别接受MNP或NP方案化疗。长春瑞宾25mg/m2静注,d18c;顺铂为75mg/m2,静脉滴注d1;MNP方案中丝裂霉素用法为6mg/m2,静注第1天。两方案均每3周重复,两周期后评价疗效,并随访毒副反应。结果 两组中位化疗周期数均为3。NP组PR为11例,总体有效率为33%;PD 5例(15%);MNP组PR为12例(38%),PD为5例(16%),与NP组相比,差异无显著性(P>0.05)。常见副反应有白细胞减少、贫血、便秘、恶心、呕吐等。MNP组Ⅲ与Ⅳ度白细胞减少症发生率高达41%;有3例因中性粒细胞减少并发感染而发热,其中1例死亡。NP与MNP组中位生存期分别为12 与11 个月,差异无统计学意义。结论 长春瑞宾联合顺铂和丝裂霉素一线治疗晚期NSCLC在疗效上不优于长春瑞宾联合顺铂,毒副反应增加;不应作为晚期NSCLC的常规一线方案。

Objectives To compare efficacy and toxicity between vinorelbine with cisplatin(NP) and vinorelbine with cisplatin with mitom ycin (MNP) both which as the first line chemotherapy for advanced non-small cel l lung cancer (NSCLC). Methods Sixty-five advanced NSCLC patie nts were randomly assigned to receive cisplatin 75mg/m 2day 1 plus vinore lbine 25mg/m 2days 1 and 8 every 3 weeks or cisplatin 75mg/m 2day 1 with vinorelbine 25mg/m 2day 1 and 8 and mitomycin 6mg/m 2day 1 every 3 weeks,Efficacy was evaluated after two cycles of chemotherapy and toxici ty was followed up.Results The median cycles in the two groups were allow 3. Rates of response and progressions of disease in NP group were 33% and 15%,respectively and in MNP group were 38% and 16%.The difference in effica cy between the two groups was not significant(P>0.05).Common side effects in cluded leukopenia,anemia,constipation,nausea/vomiting etc.About 41% of the cases in MNP group developed grade 3 or 4 neutropenia.Three patients had febrile neut ropenia,one of whom died of infection soon after the first cycle of MNP chemothe rapy,median survival times were 12 monthes in the NP group and 11monthes in the MNP group.Conclusions Vinorelbine with cisplatin plus mitomycin as first-line therapy for advanced NSCLC was not better in efficacy than the v inorelbine plus cisplatin but developed more severe side-effects and so should not be used as standard 1 stline chemotherapy regimen in advanced NSCLC.