培美曲塞或吉西他滨联合顺铂治疗晚期NSCLC随机对照研究

Randomized trial of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in treating advanced non-small cell lung cancer

目的：观察顺铂（DDP）＋培美曲塞（PEM）与DDP＋吉西他滨（GEM）联合化疗方案治疗晚期非小细胞肺癌（non_smallcelllungcancer，NSCLC）的临床疗效和不良反应。方法：将2009—07—05—2011—12—16胜利油田中心医院收治的88例晚期NSCLC患者随机分为PC组45例和GC组43例。PC组：培美曲塞500mg／m。，静脉滴入，d1；DDP75mg／m2，静脉滴入，d2～d4。GC组：吉西他滨1000mg／m2，持续静脉滴入30min，d1、ds；DDP同PC组。比较两组的临床疗效和不良反应。结果：PC、GC组近期有效率分别为42．2％（19／45）和41．9％（18／43），差异无统计学意义，P=0．772；疾病控制率分别为84．4％（38／45）和81．40％（35／43），差异无统计学意义，P=0．857；中位生存期分别为11．1和10．7个月，差异无统计学意义，P=0．747；1年生存率分别为42．2％和39．5％，差异无统计学意义，P=0．807。不良反应均可耐受。PC和GC组白细胞减少分别为44．4％（20／45）和60．5％（26／43），差异有统计学意义，P=0．023；血小板减少分别为53．3％（24／45）和76．7oA（33／43），差异有统计学意义，P=0．016。结论：培美曲塞或吉西他滨联合DDP治疗晚期NSCLC，疗效相似，但前者不良反应明显减少，可作为晚期NSCLC患者的一线治疗用药。

OBJECTIVE： To observe the efficacy and side effect of pemetrexed or gemcitabine combined with cispla- tin in treating advanced non-small cell lung cancer（NSCLC）. METHODS： Eighty-eight advanced NSCLC patients were di- vided into 2 groups randomly,45 in PC group （pemetrexed plus cisplatin）and 43 in GC group （gemcitabine plus cispla- tin）. PC group ： pemetrexed 500 mg/m2 , day 1, cisplatin 75 mg/m2 in day 2-4 ; GC group ： gemcitabine 1 000 mg/m2 , day 1, 8, cisplatin 75mg/m2 in day 2--4. Therapeutic effect and side-effects of two groups were observed. RESULTS： The re- sponse rates and disease control rate in the PC group and in the GC group were 42.2 % （19/45）, 41.9 % （18/43）, 84.4 % （38/45） ,81.40% （35/43） ,respectively. The median survival time and 1-year survival rate were 11.1 months,42.2% and 10.7 months,39.5% in the PC group and in the GC group, respectively. The efficacy in two groups had no significant difference （P〉0.05）. All adverse reactions were tolerable, leukopenia and thrombocytopenia with group PC and GC were 44.4%（20/45）, 53.3% （24/45）, 60.5 % （26/43）, 76.7 % （33/43）, respectively, and the difference was significant between both groups（P〈0.05）. CONCLUSION：Pemetrexed plus cisplatin has the same efficacy as gemcitabine plus cisplatin in the treatment of patients with NSCLC, but the toxicities are less; Pemetrexed plus cisplatin can be the first-line therapy for patients with NSCLC.