Basic clinical parameters predict gefitinib efficacy in non-small cell lung cancer.

Background: In epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), the tyrosine-kinase inhibitor gefitinib is in broad use. We retrospectively analysed data for 82 patients with advanced NSCLC treated with gefitinib and correlated benefits with clinical baseline and therapy-related parameters'. Patients: Of all patients 48182 were male; the median age at start of gefitinib was 67.2 years; 14158 informative patients were never-smokers; 57182 patients suffered from adenocarcinoma, including 7 with bronchoalveolar-carcinomas. Results: As to be expected, partial remission was observed in 10% of patients, stable disease in 29%, progression-free survival was 3.1 months and overall survival 9.2 months. Gefitinib was more efficacious in women, never-smokers and patients with bronchoalveolar-carcinoma. Furthermore, anemia and elevated C-reactive protein levels were unfavourable for therapeutic efficacy. Patients developing skin reactions under gefitinib achieved response far more frequently, with longer progression-free survival and overall survival. Conclusion: Basic clinical parameters are good predictors for response to EGFR tyrosine-kinase inhibitor therapy, which may be of value if EGFR mutation status is not available.