吉非替尼治疗125例晚期非小细胞肺癌患者的临床观察

Clinical observation of gefitinib for the treatment of 125 cases with advanced non-small cell lung cancer

目的探讨吉非替尼治疗晚期非小细胞肺癌（NSCLC）的疗效及安全性。方法125例经化疗失败的或不能耐受化疗及不愿接受化疗的Ⅲb～Ⅳ期NSCLC患者，目服吉非替尼250mg／d，直到病变进展或出现不可耐受的不良反应。结果125例患者的总有效率为35．2％（44／125），疾病控制率为77．6％（97／125），中位无疾病进展生存时间（PFS）为5．8个月，中位生存时间（MST）为11．2个月，1年生存率为40．5％。女性、腺癌、不吸烟患者的有效率明显高于男性、非腺癌、吸烟患者（P〈0．05），ECOG评分和既往有无化疗对吉非替尼疗效无显著影响（P〉0．05）。体力状态ECOG评分0～1和吉非替尼治疗有效患者的中位PFS明显优于ECOG评分≥2和吉非替尼治疗无效的患者（P〈0．01）。腺癌、不吸烟、吉非替尼治疗有效患者的MST明显优于非腺癌、吸烟和吉非替尼治疗无效的患者（P〈0．05）。最常见的不良反应为皮疹（51．2％）和腹泻（34．4％），多为轻度。结论吉非替尼治疗晚期NSCLC安全、有效，不良反应轻，患者可耐受。

Objective To evaluate the efficacy and safety of gefitinib for the treatment of advanced non-small cell lung cancer （NSCLC） . Methods 125 patients with advanced NSCLC who had failed or not tolerated or refused chemotherapy received 250 mg oral doses of gefitinib once daily until the disease progression or intolerable toxicity. Results A total of 125 NSCLC patients were studied, the overall response rate （RR） and the disease control rate （DCR） after administration of gefitinib were 35.2% （44/125） and 77.6% （97/125） , respectively. The median progression-free survival and the median survival time were 5.8 and 11.2 months, respectively. The one-year survival rate was 40.5%. The response rate was significantly higher in females, adenocarcinoma and nonsmokers than that in males, non-adenocarcinoma and smokers （P 〈0.05 ）. The response rate did not show significant differences regarding ECOG score or previous treatment. The median progression-free survival was significantly longer in ECOG PS 0-1 and gefitinib effective patients than that in ECOG PS ≥ 2 and gefitinib ineffective patients （ P 〈 0.01 ）. The median survival time was significantly longer in adenocarcinoma, nonsmokers and gefitinib effective patients than that in non-adenocareinoma, smokers and gefitinib ineffective patients （P 〈 0.05 ）. The most common side effects were rash （51.2% ） and diarrhea （ 34.4% ）, but usually were mild. Conclusion Gefitinib is effective and safe in the treatment of advanced NSCLC patients.