吉非替尼与化疗治疗老年肺腺癌的随机对照研究

Randomized Control Study of Gefitionib and Chemotherapy for Elderly Patients with Lung Adenocarcinoma

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 drug-related adverse event of Gefitionib for elderly patients with lung ade- nocareinoma. Methods： Ninety-three elderly patients were randomized divided into two groups. Forty-seven patients in the test group were treated with gefitinib（ at a dose of 250 mg per day orally）until disease progression or adverse events had become intolerable. For- ty-six patients in the control group were treated with a platinum-based two-drug combination chemotherapy or single-agent chemothera- py. Results： Response rate were 34. 0% （16/47） and 23.9% （11/46） in test group and control group respectively; disease control rate were 72. 3 % （34/47） and 67.4% （31/46）, time to progression was 6. 7months and 5.8months in test group and control group re- spectively, while overall median survival time was 8.3 months（6 ~ 18months） and 7.1 months（5.5 - 16months） in test group and control group respectively. Kaplan-Meier survival curve was used to describe OS which showed no statistic difference between the test group and the control group. The drug-related adverse events of gefitinib group were skin rash （36/47,76. 6% ） , diarrhea （22/47, 46. 8% ）, neutropenia（4/47,8.5% ）, nail chapped （ 3/47, 6.4% ）, abnormal liver function （ 3/47, 6.4% ）, hair loss （ 2/47, 4. 3% ） and vomiting（ 1/47, 2. 1% ）. Most of the side reaction were in grade Ⅰ - Ⅱ. While in the control group, the adverse events were neutropenia （44/46,92.7%）, vomiting（39/46,84. 8% ）, hair loss （29/46,63.0%）, thrombocytopenia（25/46, 54. 3% ）, anemia （ 20/46, 43.5% ）, abnormal liver function （7/46, 15.2% ） and diarrhea （ 3/46, 6. 52% ）. Subgroup analysis of gefitinib group displayed that disease remission rate and control rate patients with different gender, smoking history, ECOG score, and the num-ber of prior chemotherapy had no statistical difference. Conclusion： Gefitinib is an effective and safe drug in the treatment for elderly patients with lung adenocarcinoma.