吉非替尼治疗晚期非小细胞肺癌的临床研究

目的]观察吉非替尼(Gefitinib)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.

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

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(TTP) 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.