凡德他尼联合吉西他滨治疗老年患者晚期非小细胞肺癌的临床疗效分析

Clinical efficacy of vandetanib plus gemcitabine in the treatment of advanced non- small- cell lung cancer in ederly patients

目的评估并比较凡德他尼-吉西他滨与吉西他滨-安慰剂治疗老年患者晚期非小细胞肺癌的临床疗效。方法选取2013年2月至2014年12月首次确诊的非小细胞癌老年患者（年龄大于70岁）124例为本试验对象,随机分为A、B两组,每组62例。A组患者接受凡德他尼联合吉西他滨,B组接受吉西他滨联合安慰剂。记录患者的无进展生存期（PFS）,总生存期（OS）、客观缓解率（ORR）及疾病控制率（DCR）等疗效指标,并统计患者发热、血常规及胃肠道等不良反应的发生率。结果 A组患者中位PFS为182 d（95%CI：115~213）,明显长于B组（168 d,95%CI：95~193）,差异具有统计学意义（P〈0.05）。两组患者在OS、DOR及TDPS方面无显著性差异。A、B两组至少含有一种不良反应的发生率分别为96.6%和98.3%,A组患者厌食和皮疹的发生率显著高于B组（29%vs.14.5%,P=0.04;24.2%vs.9.7%,P=0.03）。结论凡德他尼联合吉西他滨对老年患者晚期非小细胞肺癌有明显治疗效果,可显著延长患者的无进展生存期。

Objective To evaluate the clinical efficacy of vandetanib plus gemcitabine compared with gemcitabine plus placebo for trea-ting the advanced non - small - cell lung cancer in elderly patients. Methods 124 elderly patients（age 〉 70 years）firstly diagnosed as the ad-vanced non - small - cell lung cancer from February 2013 to December 2014 in our hospital were chosen in this study,and randomly divided into group A and B with each group 62 patients. Patients in group A received vandetanib plus gemcitabine,and patients in group B received gemcit-abine plus placebo. Progression - free survival（PFS）,overall survival（OS）,objective response rate（ORR）and disease control rate（DCR） were recorded,and the incidences of adverse reactions including pyrexia,blood routine and gastrointestinal tract were also calculated. Results The median PFS was 182 days in group A（95% CI：115 ~ 213）,which is longer than group B（168 days,95% CI：95 ~ 193）,and the difference between two groups had statistical significance（ P 〈 0. 05）. There was no obvious difference in OS,DOR and TDPS between two groups. The in-cidences with at least one adverse reaction in group A and B were 96. 6% and 98. 3% ,respectively,and the incidence of anorexia and rash in group A was significantly higher than that in group B（29% vs. 14. 5% ,P = 0. 04;24. 2% vs. 9. 7% ,P = 0. 03）. Conclusion Vandetanib combined with gemcitabine has the obvious clinical efficacy for treating the advanced non - small - cell lung cancer in elderly patients,and signifi-cantly prolongs the progression - free survival.