Iressa单药治疗化疗失败后的晚期非小细胞肺癌

The salvage regimen for patients with advanced non-small cell lung cancer who failed prior chemotherapy: once-daily single oral agent Iressa

目的 初步总结Iressa单药治疗化疗失败的晚期非小细胞肺癌的近期疗效及毒副作用。方法 研究对象系日本大阪羽野病院肿瘤科 2 0 0 2年 9～ 12月的 3 1个住院病例 ,所有病例均为ⅢB或Ⅳ期的非小细胞肺癌 ,并且行 2周期以上含铂类药物的联合化疗后病情进展 (PD)或复发者。治疗方案为Iressa单药口服 2 5 0mg ,每日 1次 ,至出现PD。同时每周行一次胸部平片检查 ,每月一次胸部CT扫描。结果 3 1例入选病例中 ,1例达到完全缓解 (CR) ,7例部分缓解 (PR) ,17例病情稳定 (SD) ,完全缓解率为 3 .2 %( 95 %可信限区间CI :0～ 17%) ,部分缓解率 2 2 .6%( 95 %CI :10 %～ 41%) ,疾病控制率 (包括所有缓解病例和病情稳定的病例 ) 80 .6%( 95 %CI :5 2 %～ 92 %)。症状缓解率为 5 1.6%( 95 %CI :3 3 %～ 70 %) ,缓解最为明显的症状为咳嗽和疼痛 ,出现症状缓解的中位时间为 14天。最常见的毒副作用为Ⅰ、Ⅱ度的皮疹和腹泻 ,无 1例因毒副作用而退出。结论 口服Iressa单药对于经化疗治疗失败的晚期非小细胞肺癌 ,是一种有效且具有良好耐受性的治疗方案。

Objective To summarize the effect of Iressa for refractory patients with advanced non small cell lung cancer (NSCLC) failed to prior chemotherapy. Methods Thirty one patients, with unresectable stage ⅢB or Ⅳ NSCLC who had disease progression or relapse after prior chemotherapy using platinum based regimen for at least 2 cycles, were admitted to the Osaka Prefectural Hobikino Hospital. Iressa 250 mg was administered once a day until disease progression was noted. Weekly chest x ray and monthly CT scan were performed for response assessment each month. Results Among the 31 patients, one complete response (CR) and 7 partial responses (PR) were observed. CR rate was 3.2% (95% confidence interval: 0 17%), PR rate 22.6% (95% confidence interval: 10% 41%), disease control rate including both tumor responses and stable disease was 80.6% (95% confidence interval: 52% 92%). The rate of symptoms relieves was 51.6% (95% confidence interval: 33% 70%), the most effective symptoms being cough and pain. The median time to improved symptoms was 14 days. The most common adverse events were grade Ⅰ or Ⅱ skin rash and diarrhea which were readily manageable and reversible. No patients were withdrawn due to the adverse events. Conclusion Monotherapy using Iressa is effective and tolerable for the patients with advanced NSCLC who failed prior chemotherapy.