吉非替尼单药一线治疗晚期非小细胞肺癌临床研究

目的评价吉非替尼单药一线治疗在未经化疗的Ⅳ期非小细胞肺癌(NSCLC)患者中的有效性和耐受性。方法23例经组织学或细胞学确诊的未经化疗的Ⅳ期NSCLC患者,予以吉非替尼单药250mg/d口服,直到疾病进展或因严重不良反应不能耐受治疗。2月后评价疗效与不良反应,并随访1年生存率。结果客观有效率为26%,疾病控制率为61%;不良反应轻微,主要是皮疹、乏力、腹泻和肝功能异常。无间质性肺疾病(ILD)发生。1年生存率为58%。结论研究证实了吉非替尼单药一线治疗晚期NSCLC有效并具有良好的耐受性。

OBJ ECTIVE： To evaluate response rate and tolerance of gefitinib as first-line monotherapy on chemotherapy-naive patients with stage IV non-small-cell lung cancer （NSCLC）. METHODS： 23 chemotherapy-naive patients with stage IV NSCLC （proven by histology or cytology） were enrolled and administered orally at a dose of 250 mg daily until disease progressed or severe toxicity developed. RESULTS： The overall Objective tumor response rate was 26% and the disease control rate was 61%. The main toxicity was skin rash, fatigue, diarrhea and abnormal liver function. The toxicity was mild . There was no interstitial lung disease （ILD）. One year survival rate was 58%. CONCLUSION： Gefitinib, as a first-line monotherapy, is effective and tolerable in the treatment to chemotherapy-naive patients with stage IV NSCLC.