吉非替尼治疗52例晚期非小细胞肺癌优势人群的临床观察

Efficacy and safety of gefitinib in treating clinically selected patients with advanced non-small cell lung cancer

目的探讨吉非替尼单药治疗临床选择的晚期非小细胞肺癌患者的疗效与不良反应。方法2007年1月～2008年10月共52例、腺癌、不吸烟的晚期非小细胞肺癌患者接受吉非替尼250mg/d口服治疗,观察患者的疗效、TTP、MST和毒副反应。结果本组52例患者均可评价疗效,其中完全缓解3例,部分缓解21例,无变化22例,进展6例。有效率为46.2%,疾病控制率为88.5%,中位TTP为454.67天,1年无进展生存率为52%,MST为597.9天,1年生存率为60%。最常见不良反应主要为皮疹和腹泻。有效率与患者性别、年龄、一般状况、分期及既往治疗无关;与皮疹相关,没有皮疹的病人疗效差(ORR=0.143,95%CI:0.035～0.590)。TTP与患者性别、一般状况、分期及既往治疗无关;只有患者年龄与TTP相关,50岁以下病人的TTP明显缩短疾病进展风险增加(HR=4.196,P=0.0005);腹泻与TTP相关,没有出现腹泻的病人疾病进展风险大(HR=2.637,P=0.0303)。结论吉非替尼治疗河南本地腺癌、不吸烟的晚期NSCLC的疗效显著,总体生存明显获益,不良反应轻微。

Objective To evaluate the efficacy and toxicity of gefitinib in the treatment of clinically selected advanced non-small cell lung cancer（NSCLC）.Methods From January 2007 to October 2008,52 advanced NSCLC patients（non-smokers,adenocarcinoma,from Henan Province） to attend Expanded Access Program（EAP） were retrospectively reviewed.All patients had received gefitinib 250mg/d until disease progression or intolerable toxicity development.The efficacy,time-to-progression,median survival time,and toxicity were analyzed.Results All fifty-two patients were evaluated.Three cases got complete response,21 cases got partial response,22 cases had no change,and 6 had disease progression. Therefore,the response rate was 46.2%,and the clinical benefit rate was 88.5%.Median timeto -progression and median overall survival period were 454.6 and 597.9 days,respectively.One year progression-free survival rate and 1-year overall survival rate were 52%and 60%,respectively.The common adverse effects were skin rash and diarrhea.There was no correlation between the response rate and age,PS,chemotherapy history,or TNM stage.Response rate was related to skin rash.The therapeutic effect was not well in the patients who have no skin rash（ORR=0.143,95%CI：0.035-0.590）.There was no correlation between TTP and age,PS,chemotherapy history,or TNM stage.TTP was related to diarrhea. The disease progression risk was high in patients who had no diarrhea（HR=2.637,P=0.0303）. Conclusion Gefitinib is effective and safe in treating advanced NSCLC patients.