培美曲塞及吉西他滨分别联合顺铂治疗初治晚期非小细胞肺癌安全性和有效性的随机对照研究

背景与目的由于不同个体间肿瘤细胞的生物学特性差异以及现有药物在疗效和不良反应方面仍存在的一定缺陷,故本研究旨在比较培美曲塞及吉西他滨分别联合顺铂治疗初治晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床疗效及毒副作用。方法 251例患者被随机分为培美曲塞联合顺铂组(PP组)127例和吉西他滨联合顺铂组(GP组)124例。PP组:培美曲塞500mg/m2,d1,顺铂75mg/m2,d1。GP组:吉西他滨1,000mg/m2,d1,8,顺铂75mg/m2,d1。两组治疗周期均为每3周1次。此外,两组均合并给药叶酸、VitB12和地塞米松。结果 PP组和GP组患者的总有效率分别为25.20%和17.74%,其中非鳞癌患者总有效率分别为27.62%和16.00%。两组肿瘤进展时间分别为6.5个月和5.6个月,中位生存期分别为16.9个月和17.0个月,1年生存率分别为59.62%和65.87%,2年生存率分别为27.28%和27.93%。PP组非鳞癌的总有效率明显高于GP组,结果具有统计学意义。但两组总缓解率、肿瘤进展时间、中位生存期、1年及2年生存率均无明显性差异。从不良反应来看,PP组的白细胞减少、血小板降低、血红蛋白降低、脱发等不良反应明显低于GP组,结果具有统计学意义。结论培美曲塞联合顺铂治疗晚期非小细胞肺癌与吉西他滨联合顺铂疗效相当,但副作用明显减少。总之,培美曲塞联用顺铂可以作为安全有效的药物对初治的非小细胞肺癌进行临床一线治疗。

Efficacy and Toxicity of Pemetrexed or Gemcitabine Combined with Cisplatin in the Treatment of Patients with Advanced Non-small Cell Lung Cancer

Background and objective Due to the various inter-individual differences in the biological characteristics of tumor cells, as well as issues on the efficacy, adverse reactions, and defects of existing drugs, we compared the clinical efficacy and toxicity of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced non-small cell lung cancer (NSCLC). Methods 251 patients were randomly divided into pemetrexed combined with cisplatin group (PP group) with 127 cases and gemcitabine combined with cisplatin group (GP group) with 124 cases. PP group received pemetrexed 500 mg/m2 iv infusion d1 and cisplatin 75 mg/m2 iv infusion d1, whereas GP group received gemcitabine 1,000 mg/m2 iv infusion d1,8 and cisplatin 75 mg/m2 iv infusion d1. The treatment cycle was once every three weeks. In addition, folic acid, vitamin B12, and dexamethasone were administered in both groups. Results The total clinical effective rates in PP group and GP group were 25.20% and 17.74%, respectively. The total efficiencies of non-squamous cell carcinoma were 27.62% and 16.00%. The tumor progression duration in these two groups was 6.5 and 5.6 months, respectively. The median survival time in the two groups was 16.9 and 17.0 months, respectively, with 59.62% and 65.87% survival rates of 1 year and 27.28% and 27.93% survival rates of 2 years, respectively. The total efficacy of non-squamous cell carcinoma in the PP group was significantly higher than that in GP group. The results were statistically significant. However, there were no significant differences in total response rates, tumor progression duration, and median survival rates of 1 and 2 years. The rate of adverse reactions, including white blood cell reduction, lower platelet count, lower hemoglobin, and hair loss in the PP group was significantly lower than that in the GP group. The results were statistically significant. Conclusion The clinical efficacy of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced NSCLC was roughly the same, but the adverse reactions decreased significantly in the PP group compared with those in the GP group. Therefore, pemetrexed combined with cisplatin can be used as a safe and effective drug for clinical first-line treatment for previously untreated NSCLC.