吉非替尼治疗晚期非小细胞肺癌的临床研究  

Safety and efficacy of gefitinib for treatment of advanced non-small cell lung cancer

作　　者：冯仲珉[1] 刘艳娥[1] 孙利敏[1] 孙鹏[1] 孙艳[1] 

机构地区：[1]大连医科大学第二临床学院北院肿瘤科,辽宁大连116031

出　　处：《大连医科大学学报》2007年第6期546-549,共4页Journal of Dalian Medical University

摘　　要：[目的]观察吉非替尼(Gefitin ib)治疗含铂类化疗失败的晚期非小细胞肺癌的疗效及毒副作用。[方法]对76例含铂类化疗失败的晚期非小细胞肺癌患者给予吉非替尼250 mg/d口服治疗,持续服用直到疾病进展或出现不可耐受的毒副作用。[结果]76例患者中完全缓解(CR)3例(3.9%),部分缓解(PR)19例(25.0%),稳定(SD)30例(39.4%)。总有效率(RR)为28.9%。临床获益率为68.3%(52/76)。有效患者的中位缓解时间为8.3个月,中位肿瘤进展时间(TTP)为5.8个月,中位总生存期(OS)为12个月,1年生存率为47.6%。女性患者的有效率显著高于男性患者(P<0.001)。与药物相关的毒副作用依次为:皮疹29例(38.0%),腹泻16例(21.0%),皮肤干燥11例(14.43%),搔痒12例(15.7%)。其他亦可出现恶心、ALT轻度升高等。[结论]吉非替尼可有效治疗含铂类化疗失败的晚期非小细胞肺癌。吉非替尼的毒副作用可耐受。[ Objective] To observe the efficacy and drug- related toxicity of gefitinib as second -line treatment for previously cisplatin - based treated patients with refractory and advanced non - small cell lung cancer. [ Methods ] Seventy - six patients with refractory and advanced non - small cell lung cancer which were about to undergo progression after previously cisplatin - based chemotherapy were eligible for this study. Gefitinib was given, as single drug, at a dose of 250 mg once daily by oral intake until the disease progression or toxicity has become intolerable. [ Results] Seventy -six such patients were evaluable for response and toxicity assessment. The overall rate of objective response and disease control was 28.9% （22/76） and 68.3% （52/76）. The median duration of reaponse was 8.3 months. The median time to disease progression （TIP） was 5.8 months and the median overall survival time （OS） was 12 months. The actuarial 1 - year survival was 47.6%. The response rate in female was significantly higher than that in male （ P 〈 0.001 ）. The drug - related toxicities of gefitinib were skin rash, diarrhea, xerosis cutis a, et al were mild and reversible. [ Conclusion] Gefitinib is effective and safe as a second - line treatment for previously cisplatin - based treated patients with refractory and advanced non - small cell lung cancer.

关 键 词：吉非替尼(Gefitinib) 非小细胞肺癌 靶向治疗 

分 类 号：R734.2[医药卫生—肿瘤]