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

关键词:  吉非替尼（Gefitinib）  非小细胞肺癌  靶向治疗

Key words:  gefitinib  non-small cell lung cancer  targeted therapy

摘要:

［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。

Abstract:

［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.［Conclusions］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.