吉非替尼一线治疗晚期非小细胞肺癌的疗效和生存因素分析

Efficacy of gefitinib on advanced non-small cell lung cancer and analysis of survival associated factors

目的:分析吉非替尼一线治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效、中位生存期、无进展生存时间,同时分析与疗效和生存期可能相关的因素。方法:回顾性分析2005年3月-2008年8月期间解放军总医院收治NSCLC患者的临床资料,其中95例经病理或细胞学证实IIIb-Ⅳ期的患者一线口服吉非替尼250 mg/d直至出现严重不良反应或病灶进展,服药前及服药后每4周进行肿瘤评估。采用SPSS 11.0统计软件,以α=0.05为检验水准。用χ2检验和Logistic回归分析比较不同因素在有效率及疾病控制率方面有无差异,用Kaplan-Meier进行生存分析,log-rank检验分析不同基线特征及治疗反应的生存差异。用Cox风险比例模型分析服用吉非替尼后的PFS和OS进行多因素分析。结果:客观有效率为10.5%,疾病控制率为76.8%,中位PFS 8.34个月,中位OS时间为17.38个月。1年、2年的生存率分别为61.9%和25%。χ2检验及Logistic多因素分析显示仅有年龄在疾病缓解率上有统计学差异(P=0.0302),其它各个分组因素在疾病缓解率和疾病控制率方面均未见明显差异。性别、病理影响患者的PFS时间,女性(P=0.0214)及腺癌(P=0.0264)患者PFS时间较长,但Cox多因素分析未见明显统计学差异。不同病理类型,既往肺部肿瘤切除与否,性别,服用TKI后疾病缓解和控制情况影响患者的总生存时间。其中腺癌,曾行手术切除肺部肿瘤,女性,服用TKI后CR/PR/SD的患者总生存时间较长,但经Cox多因素分析后,仅有病理类型和服用TKI后早期疗效与OS时间相关。肿瘤病理类型(P=0.0077)与早期疗效(P=0.0000)为预后的独立影响因素。腺癌与非腺癌相比,PFS和OS明显延长,CR/PR/SD的患者与PD患者相比OS明显延长,CR/PR的患者与SD患者相比,其OS时间未见明显差异。性别与吸烟状况在疗效、长期生存中均未见明显差异。结论:吉非替尼一线治疗局部晚期和转移性非小细胞肺癌有较好的近期疗效和生存益处。腺癌和含腺癌的混合亚型,早期服用后疗效较好的患者可能是生存有益的标志。

Objective：To evaluate the efficacy of Gefitinib on the median overall survival time,median progression free survival time,response rate,disease control rate of the patients with advanced non-small cell lung cancer（NSCLC） and to identify the survival associated factors.Methods：From March 2005 to August 2008,95 consecutive patients with advanced NSCLC in our hospital,who received gefitinib,were reviewed.Efficacy and overall survival were analyzed by SPSS 11.0 software.Results： The response rate and disease control rate of Gefitinib in NSCLC were 10.5% and 76.8%.One and two years survival rates were 61.9% and 25% respectively.The median progress free survival time and the median overall survival time of all patients were 8.34 months and 17.38 months.Patients who were yunger than 65 years showed better response than the opposite population.For patients who had adenocarcinoma（including bronchioalveolar carcinoma）,response were CR/PR/SD,female,and those who received operation before had significantly longer median survival time.The pathology,response to gefitinib were independent prognostic factors of overall survival time of gefitinib treatment by Cox proportional hazard models.Gender,smoker or not,histology and other status had no significant effects on the clinical outcome and long-term survival time.Gefitinib was well tolerant,with rash and diarrhea as commonly adverse events.Conclusion：Gefitinib had good efficacy to the patients with advanced or metastasis NSCLC in China.Adenocarcinoma（including bronchioalveolar carcinoma）,response and disease control were prognostic factors in advanced NSCLC.