OBJECTIVETo investigate the efficacy, time to progression, survival time and toxicity of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor Gefitinib (Iressa), a target therapy agent, in the treatment of advanced non-small cell lung cancer (NSCLC), and to analyze the factors affecting the efficacy and patients' survival.

METHODSFrom Nov. 2003 to May 2005, 91 patients with advanced NSCLC who failed from previous first-line chemotherapy were treated by gefitinib in this trial with a median chemotherapy cycle of six. Sixty-eight of these 91 patients (74.7%) had received a second-line chemotherapy. Seventy-six (83.5%) of the 91 patients had stage IV disease, and 42 (46.2%) had developed metastases at least two sites. Gefitinib was administered orally at a dose of 250 mg daily until disease progressed or severe toxicity developed. Clinical data were analyzed using chi-square test, Log-lank test, Cox regression and Kaplan-Meier survival analysis in SPSS 11.5.

RESULTS(1) Overall response rate was 20.9% (19/91) and the disease control rate (response and stable disease) was 63.7% (58/91). Patients'symptoms were improved in 72.7% (40/55), and ECOG score was improved or remained stable in 71.4% (65/91). The disease control rate of those who had adenocarcinoma, or received second-line chemotherapy or developed skin toxicity was significantly better than the other patients (P value = 0.04, 0.02, 0.00, respectively). (2) Median time to progress (TIP) was 5.0 months (95% CI 3.26-6.74). (3) Median following-up duration was 7.5 months (1-18. 5 months), and 1-year survival rate was 56.4%. Of the 56 patients (61.5%) who were still alive when following-up ended, 29 (51.8%) had stable disease, 20 had survived more than one year (12-18. 5 months). Non-smoker, stable diseases, skin toxicities, and controlled metastatic diseases during the treatment of gefitinib were the favorable factors affecting the survival (P value = 0.00, 0.00, 0.00, 0.01, respectively). (4) The main toxicity of gefitinib was grade I or II skin toxicity.

CONCLUSIONGefitinib, a target therapy agent which may be an alternative, is effective and tolerable in the treatment for advanced NSCLC patients who have failed in the first-line or even second-line chemotherapy. It can remarkablely improve the disease control rate and disease-related symptoms, and also prolong survival in the responders.