Background: The aim of this study is to detect the efficacy and toxicity of gemcitabine and vinorelbine (GN as second-line or further-line treatment) in refractory advanced non-small cell lung cancer (NSCLC) patients in China.
Methods: We retrospectively reviewed 53 NSCLC patients treated with this agent at four hospital in China from Jan 01, 2004 to Jun 30, 2010. Survival analysis was evaluated by Kaplan-Meier method.
Results: A total of 53 patients were analyzed in this study (28 patients in second-line and 25 in third- or further-line treatment). The objective response rate (ORR) was 9.4%. The disease control rate (DCR) was 56.6%. The progression-free survival (PFS) and median overall survival (OS) was 3.0 and 17.6 months, respectively. Univariate analysis, revealed performance status (PS) score was an independent prognostic factor for overall survival.
Conclusions: The GN agent is effective for the second-line or further-line treatment in advanced non-small cell lung cancer. The toxicity is well tolerated .
背景与目的: 本研究旨在回顾性分析使用吉西他滨+长春瑞滨（GN）方案治疗复治晚期非小细胞肺癌的疗效和安全性。
方法: 通过非干预的方式收集国内4家医院2004年1月1日-2010年6月30日间行GN方案治疗的晚期非小细胞肺癌二线或二线以上的患者，评价该化疗方案的疗效、无进展生存期、中位生存期和毒副反应。卡方检验比较二线和二线以上患者的疗效差异，应用Kaplan-Meier法进行生存比较和分析。
结果: 共53例患者在二线或二线以上采用了GN方案，其中二线患者28例，三线或三线以后的患者25例，所以患者均可评价疗效和不良反应。客观缓解率（objective response rate, ORR）为9.4%，疾病控制率（disease control rate, DCR）为56.6%，中位无进展生存期（progression free survival, PFS）为3.0个月，中位总生存期为17.6个月，多数患者的毒副反应可以耐受。单因素分析显示体能状况评分（performance status, PS）是影响患者PFS的因素。
结论: 吉西他滨联合长春瑞滨方案在晚期非小细胞肺癌复治患者中有较好的疗效和安全性，可以作为一种治疗选择。