吉非替尼单药维持治疗在肺腺癌中的临床疗效观察  

Clinical investigation on the efficacy of maintenance therapy with gefitinib in pulmonary adenocarcinoma

作　　者：权琳[1,2] 陈文萍[2] 徐玲[2] 束永前[1] 

机构地区：[1]南京医科大学第一附属医院肿瘤科,江苏南京210029 [2]南京市胸科医院呼吸内科,江苏南京210029

出　　处：《南京医科大学学报（自然科学版）》2010年第7期994-997,共4页Journal of Nanjing Medical University(Natural Sciences)

摘　　要：目的:研究单药吉非替尼在成人肺腺癌常规化疗后维持治疗中的临床疗效和安全性。方法:60例ⅢB和Ⅵ期肺腺癌患者经过常规铂类为主的化疗方案后,随机分组,治疗组24例患者以吉非替尼250mg/d,口服进行维持治疗,对照组36例患者进行密切随访,研究终点为疾病进展或患者死亡。疾病无进展生存期(PFS)和总生存期(OS)使用Kaplan-Meier方法统计,并且分析影响预后的不同因素。结果:吉非替尼单药维持治疗组平均PFS为8.2[95%可信区间(confidence interval,CI):7.6～8.8]个月,随访组观察平均PFS为5.2(95%CI:4.6～5.8)个月,两组差异具有明显统计学意义(P<0.01);平均OS在两组分别为15.0(95%CI:12.2～17.8)个月和8.8(95%CI:8.5～9.1)个月,两组具有明显统计学差异(P<0.01)。吉非替尼组主要不良反应为皮肤反应、腹泻和厌食等,经过对症处理均可以控制,未发生药物相关死亡。结论:吉非替尼单药作为晚期肺腺癌常规维持治疗可以显著提高PFS和OS,并且不良反应相对较小。Objective：To investigate clinical efficacy and safety of gefitinib as single-agent maintenance therapy after first-line chemotherapy in patients with advanced pulmonary adenocarcinoma.Methods：A total number of 60 adults advanced pulmonary adenocarcinoma patiensts were enrolled in this clinical trial,and randomized into gefitinib treatment group and observation control group after conventional cisplatin-base chemotherapy.Gefitinib was oral administered at the dose of 250 mg/d in treatment group as maintenance therapy,the primary end point was defined as death from any cause or disease progression.Median progression free survival（PFS）and overall survival（OS）were evaluated by Kaplan-Meier method.Results：Median PFS in gefitinib group was 8.2 months（95% CI：7.6～8.8）vs 5.2 months（95%CI：4.6～5.8）in observation group（P0.01）,and median OS was 15.0 months（95%CI：12.2～17.8）vs 8.8 months（95%CI：8.5～9.1）respectively（P0.01）.The major toxic effects of gefitinib were rash,acne,diarrhea and anorexia,all of which were manageable after supportive treatment,and no therapy-associated death occurred.Conclusion：Single-agent gefitinib as maintenance therapy can prolong PFS and OS of advanced pulmonary adenocarcinoma patients significantly,and side effects are manageable.

关 键 词：吉非替尼 肺腺癌 维持治疗 

分 类 号：R730.53[医药卫生—肿瘤] R734.2[医药卫生—临床医学]