索拉非尼联合化疗一线治疗非小细胞肺癌的临床研究

Sorafenib plus Chemotherapy for First-line Treatment of Non-small Cell Lung Cancer

目的研究索拉非尼联合吉西他滨/顺铂化疗一线治疗非小细胞肺癌的疗效和安全性。方法将Ⅳ期非小细胞肺癌患者采用随机、对照、双盲法分为索拉非尼联合吉西他滨/顺铂化疗组(试验组)和安慰剂联合吉西他滨/顺铂化疗组(对照组),分析其疗效和安全性。结果试验组和对照组的中位总生存期(OS)分别为12.8个月和12.7个月(P=0.369),中位无进展生存期(PFS)分别为7.4个月和4.3个月(P=0.070),两组的1、2、5年生存率分别为58.3%和52.9%(P=0.537),41.7%和29.4%(P=0.385),8.3%和0%(P=0.414),半年、1年无疾病进展生存率分别为58.3%和41.2%(P=0.297),16.7%和0%(P=0.163),差异均无统计学意义。不良反应发生情况两组相似,耐受性良好,试验组发生手足综合征率高于对照组(P=0.007)。结论索拉非尼联合吉西他滨/顺铂化疗与单纯化疗一线治疗非小细胞肺癌比较,并未带来明显生存获益。

Objective To evaluate the clinical efficacy and adverse effects of sorafenib plus chemotherapy in the first-line treatment of non-small cell lung cancer（NSCLC）.Methods The stageⅣ NSCLC patients were divided into two groups in a random,controlled and double-blinded manner：sorafenib plus gemcitabine＋cis-platinum（GP）group and placebo plus GP group.The efficacy and safety of sorafenib plus GP chemotherapy were analyzed.Results The median overall survival（OS） was 12.8months and 12.7months in the sorafenib plus GP group and placebo plus GP group,respectively（P=0.369）.The median progression-free survival（PFS）was 7.4months and 4.3months in the sorafenib plus GP group and placebo plus GP group,respectively（P=0.070）.The 1-year,2-year,5-year OS rates were 58.3% vs.52.9%,41.7%vs.29.4%,and 8.3% vs.0%in the sorafenib plus GP group and placebo plus GP group,respectively（P=0.537,P=0.385,P=0.414）.The 6-month PFS rate and 1-year PFS rate were 58.3%vs.41.2%and 16.7%vs.0%in the sorafenib plus GP group and placebo plus GP group,respectively（P=0.297,P=0.163）.The occurrence of adverse effects was similar in the two groups.Patient tolerability was good in the sorafenib plus GP group.The incidence of hand-foot syndrome was increased in the sorafenib plus GP group compared with the placebo plus GP group（P=0.007）.Conclusion No survival benefits were observed in first-line treatment of NSCLC with sorafenib in combination with GP chemotherapy.