吉非替尼与紫杉醇联合卡铂治疗晚期肺腺癌患者的效果分析

Efficacies of gefitinib versus paclitaxel/carboplatin for patients with advanced pulmonary adenocarcinoma

目的 比较分析吉非替尼与紫杉醇联合卡铂治疗晚期肺腺癌患者的临床效果.方法 纳入2006年10月至2007年9月,广东省人民医院收治的年龄≥18岁,未接受过化疗、生物学或免疫学治疗的不吸烟或少吸烟晚期肺腺癌患者,按体能状态（PS）评分、吸烟状况和性别采用动态均衡随机化方法随机纳入吉非替尼组和联合化疗组,吉非替尼组接受一线吉非替尼治疗（250 mg,口服,1次/d）,联合化疗组接受化疗[紫杉醇200 mg/m2,静脉滴注,21d为1个周期;卡铂按剂量血药浓度-时间曲线下面积（AUC） =5 mg.ml-1·min-1计算,静脉输注,21 d为1个周期,两药都在每周期的第1天使用].主要终点指标是无进展生存期（PFS）,次要终点指标是客观缓解率（ORR）和总生存期（OS）.结果 共纳入51例患者,其中吉非替尼组25例,联合化疗组26例;两组中位PFS分别为4.2个月和8.3个月（P =0.422）,ORR分别为36.0％和42.3％ （P =0.645）,中位OS分别为14.4个月和15.0个月（P =0.290）.多因素Cox回归分析显示：年龄（P=0.004）、表皮生长因子受体（EGFR）基因突变状态（P =0.012）和后续治疗[含铂化疗,P=0.001;EGFR-酪氨酸激酶抑制剂（TKI）,P=0.005]是OS显著的预后影响因素.结论 对于不吸烟或少吸烟的晚期肺腺癌患者,一线吉非替尼治疗与紫杉醇联合卡铂化疗的客观疗效近似.但限于样本量的不足,我们仍然不推荐基于临床因素一线选择吉非替尼治疗晚期非小细胞肺癌.

Objective To compare the clinical efficacies of gefitinib versus paclitaxel/carboplatin in patients with advanced pulmonary adenocarcinoma.Methods A total of 51 advanced pulmonary adenocarcinoma patients were recruited from Guangdong General Hospital during October 2006 to September 2007.Eligible patients were ≥ 18 years old,either non-smokers or former light smokers and receiving no prior chemotherapy or biological/immunological therapy.According to performance status,smoking status and gender,they were selected with dynamic equilibrium randomized method 1：1 to receive first-line gefitinib （250 mg/d） in gefitinib arm or carboplatin/paclitaxel （carboplatin,area under the curve 5 mg · ml-1 · min-1,21-day cycle; paclitaxel,200 mg/m2,21-day cycle in chemotherapy ann.The primary endpoint was progression free survival （PFS）.And the secondary endpoints were objective response rate （ORR） and overall survival （OS）.Results They were randomized into gefitinib arm （n =25） and paclitaxel/carboplatin arm （n =26）.The median PFS was 4.2 months in gefitinib arm and 8.3 months in paclitaxeL/carboplatin arm （P =0.422） ; ORR 36.0％ in gefitinib arm and 42.3％ in paclitaxel/carboplatin arm （P =0.645） ; Median OS 14.4 months in gefitinib arm and 15.0 months in paclitaxel/carboplatin arm （P =0.290）.Multifactorial Cox regression analysis showed that age （P =0.004）,epidermal growth factor receptor （EGFR） gene mutation status （P =0.012） and subsequent treatments （platinum-based chemotherapy,P =0.001; EGFR-tyrosine kinase inhibitors （TKI）,P =0.005） were the significant predictors of OS.Conclusions No significant differences exist in terms of efficacy and survival between first-line gefitinib and paclitaxel/carboplatin for Chinese patients with pulmonary adenocarcinoma who are non-smokers or former light smokers.And age,EGFR gene mutation status and subsequent treatments are significant predictor of OS.However,first-line gefitinib should not be recommended for advanced non-small cell lung cancer （NSCLC） patients only based on clinical factors,due to a very small sample-size in our study.