吉非替尼对晚期非小细胞肺癌疗效和毒副作用的分析

Analysis of factors contributed to anticancer and adverse effects in advanced non-small cell lung cancer with gifitinib

收集我科2005年2月～2006年9月病理确诊的复发/转移或局部晚期的非小细胞肺癌(NSCLC)患者36例,单药口服吉非替尼(易瑞沙)250mg/kg,>30d,分析影响吉非替尼疗效和毒副作用的因素。结果:36例患者均可评效,CR1例,PR25例,SD4例,PD6例,客观有效率为72.2%,疾病控制率为83.3%。吸烟与RR、DCR、TTP时间相关(P值分别为0.049、0.024和0.03344),性别、年龄与RR相关(P值分别为0.026和0.028),KPS<60的患者生活质量明显提高,P=0.0482;总的中位TTP为5.5个月。与药物相关的不良反应依次是皮肤干燥、皮疹、腹泻、指(趾)甲改变等不良反应,皮肤干燥和皮疹与RR相关(P值分别为0.012和0.022)。初步研究结果提示,吉非替尼治疗晚期NSCLC的疗效确切,毒副作用小,大多为轻-中度,可耐受。吸烟是预后不良因素,性别、年龄、皮肤干燥和皮疹与近期疗效相关。

Thirty-six patients confirmed with relapse/metastasis or advanced NSCLC by pathology were orally administrated once daily gifitinib 250 mg/d for more than 30 days from Feb. 2005 to Sep. 2006. The factors comributed to anticancer effects and adverse events were analyzed by using SPSS 11.5. Results： All patients might be evalua ted. Of all patients, the complete response （CR） was 1 case,partial response（PR）was in 25 cases,stable disease（SD） was in 4 cases,progressive disease was 6 cases, and the objective response rate （RR）and disease control rate （DCR） were 72.2% and 83.3%, respectively. Smoking was relate to RR（P=0.049）, DCR（P=0.024）, TTP（P= 0. 033 44）, sex and age were relate to RR（P=0.026,P= 0. 028）, respectively. The patients of KPS 〈60 could improve quality of life significantly, P=0. 048 2. The median time to progression was 5.5 months. The most common drug-related adverse events were xerosis cutis, skin rash, diarrhea, nail change etc. Xerosis curls and skin rash were relate to RR （P=0. 012, P= 0. 022）, respectively. The investigation indicates that gefitinib is an effective and safe drug in the treatment of advanced NSCLC. Smoking is a predictive factor and sex, age, xerosis curls, skin rash are re late to the response rate in advanced NSCLC patients.