吉非替尼治疗老年晚期非小细胞肺癌的临床研究

Study of gefitinib in the treatment of the elderly patients with advanced non-small cell lung cancer

目的探讨表皮生长因子受体酪氨酸激酶抑制剂吉非替尼治疗老年晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法选择46例≥65岁老年晚期NSCLC患者,吉非替尼250 mg,口服,每日1次,服用至病情进展(PD)或出现不可耐受的不良反应。患者在治疗后每月进行复查。结果本组46例均可评价疗效,其中部分缓解(PR)12例(26.09%)、稳定(SD)20例(43.48%)、PD 14例(30.43%)。疾病控制率(PR+SD)为69.57%。中位疾病进展时间(TTP)为3.8月,1年生存率为28.26%,肿瘤相关症状改善率为63.33%。常见不良反应为皮疹和腹泻,大部分为Ⅰ、Ⅱ度。结论吉非替尼单药治疗老年晚期NSCLC疗效明确,不良反应相对较小,患者耐受性好。

Objective To evaluate the efficacy and toxicity of gefitinib, an epidermal growth factor receptor（EGFR） - tyrosine kinase inhibitor, in the treatment of the elderly patients with advanced non-small cell lung cancer （ NSCLC ）. Methods Forty-six elderly patients with stage Ⅲ or Ⅳ NSCLC were enrolled. Gefitinib was administered orally 250 mg daily until disease progression or development of intolerable toxic reaction. Tumor-evaluation was carried out before the treatment and one month after gefitinib administration. Results Overall 46 cases were analyzed. There were no cases showing complete regression. The rate of partial response （PR） was 26.09% （12/46） , the rate of stable disease （SD） was 43.48% （20/46）, and the rate of progression of disease （PD） 30.43% （14/46）. The disease control rate was 69.57%. Median time to tumor progression （TTP） was 3.8 months. Among them, 13 patients were followed up and the 1-year survival rate was 28.26%. Symptomatic improvement rate was 63.33%. The most common adverse effects were skin reactions and diarrhea which were generally mild （ grade Ⅰ or Ⅱ ）. Conclusions Monotherapy with gefitinib is effective and tolerable for the elderly with advanced NSCLC.