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目的:观察吉非替尼治疗老年肺腺癌的疗效及不良反应方法:93例老年(≥65岁)肺腺癌患者采用随机数字表法随机分为两组,试验组47例使用吉非替尼(250 mg,po,Qd)治疗至病情进展或出现严重不良反应:对照组46例予以铂类药物为基础的两药联合方案或单药化疗。结果:吉非替尼组和化疗组的疾病缓解率分别为34.0%(16/47)和23.9%(11/46);疾病控制率分别为72.3%(34/47)和67.4%(31/46);疾病进展时间分别为6.7个月和5.8个月;中位生存时间分别为8.3个月(6个月～18个月)和7.1个月(5.5个月～16个月);两组生存情况采用Kaplan-Meier生存曲线分析,Log-rank检验两组生存时间差异没有统计学意义。吉非替尼组的不良反应依次为:皮疹36例(76.6%),腹泻22例(46.8%),粒细胞减少4例(8.5%),趾、指甲皲裂3例(6.4%)肝功能异常3例(6.4%),脱发2例(4.3%),呕吐1例(2.1%),多为Ⅰ度～Ⅱ度。化疗组的不良反应依次为:粒细胞减少44例(95.7%),呕吐39例(84.8%),脱发29例(63.0%),血小板减少25例(54.3%),贫血20例(43.5%),肝功能异常7例(15.2%),腹泻3例(6.52%)。通过对吉非替尼组进行亚组分析可见,不同性别、吸烟史有无、不同ECOG评分以及既往化疗方案数患者的缓解率及疾病控制率差异均没有统计学意义。结论:吉非替尼治疗老年肺腺癌有较好的疗效及安全性。
Objective: To observe the efficacy and adverse reactions of gefitinib in the treatment of elderly patients with lung adenocarcinoma.Methods: Ninety-three elderly patients (≥65 years old) with lung adenocarcinoma were randomized into two groups randomly. The experimental group received gefitinib Nepalese (250 mg, po, Qd) until the progression of the disease or serious adverse reactions: 46 cases in the control group were treated with platinum-based two-drug combination regimen or single-agent chemotherapy. Results: The remission rates of gefitinib group and chemotherapy group were 34.0% (16/47) and 23.9% (11/46), respectively. The disease control rates were 72.3% (34/47) and 67.4% (31 / 46). The duration of disease progression was 6.7 months and 5.8 months respectively. The median survival time was 8.3 months (6 months to 18 months) and 7.1 months (5.5 months to 16 months) Survival was analyzed using Kaplan-Meier survival curves, Log-rank test was no significant difference in survival time between the two groups. The adverse reactions in gefitinib group were as follows: skin rash in 36 cases (76.6%), diarrhea in 22 cases (46.8%), neutropenia in 4 cases (8.5%), toe and nail cracked in 3 cases 3 cases (6.4%), hair loss in 2 cases (4.3%), vomiting in 1 case (2.1%), mostly degree Ⅰ ~ Ⅱ. Chemotherapy group had adverse reactions in 44 cases (95.7%), vomiting in 39 cases (84.8%), alopecia in 29 cases (63.0%), thrombocytopenia in 25 cases (54.3%) and anemia in 20 cases (43.5% , Hepatic dysfunction in 7 cases (15.2%) and diarrhea in 3 cases (6.52%). By subgroup analysis of gefitinib group, we can see there is no significant difference in the remission rate and disease control rate among different gender, smoking history, different ECOG scores and the number of previous chemotherapy regimens. Conclusion: Gefitinib treatment of elderly lung adenocarcinoma has a good effect and safety.