OBJECTIVETo study the anti-tumor effect and toxicity of Gefitinib in the treatment of patients with advanced non-small-cell lung cancer (NSCLC).

METHODSFrom August 2003 to February 2005, 50 advanced NSCLC patients were treated with Gefitinib orally 250 mg once per day. All patients were stratified by gender, histology, smoking history and chemotherapy cycles. The response was evaluated as the time to tumor progression (TTP) and the median survival time (MST). Quality of life (QoL) was assessed using the Chinese version of European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-30 and the brief fatigue inventory (BFI).

RESULTSEven though none of these patients achieved complete response, 16.0% of them still gave partial response. Clinical benefit rate was 60.0% in this series. Objective tumor response was correlated with gender, pathological type and smoking history. Multivariate analysis suggested that gender, chemotherapy cycles and QoL obviously correlated with the tumor response. Twenty of these 50 patients (40.0%, 20/50) were still alive when the follow-up ended in February 2005. The 1-year survival rate was 14.0%. TTP and MST was 5 and 6 months, respectively, in patients who had been dead. The median survival time of patients who are still alive was 13 months. The mean survival time of PR patients was more than 9 months. The rate of QoL improvement was 58.0% and the rate of fatigue remission was 52.6%. The mean time to symptom improvement was 15 days. The main toxicities were reversible grade I or grade II skin rash and diarrhea. Two patients who developed radiation pneumonitis during previous radiotherapy became more deteriorated after Gefitinib treatment.

CONCLUSIONGefitinib is effective and tolerated by the patients with advanced non-small cell lung cancer. It may remarkablely improve their symptoms and quality of life.