Introduction: Gefitinib (Iressa, ZD 1839; AstraZeneca) is a selective Epidermal Growth Factor receptor tyrosine kinase inhibitor. In two randomized phase II trials (IDEAL 1 and IDEAL 2), it has demonstrated an activity against NSCLC, showing partial response and symptoms improvement rates respectively in about 20% and 40% of patients. Multivariate analyses revealed that being a woman, a non-smoker and having an adenocarcinoma was associated with response rate.
Methods: We describe a retrospective study of patients receiving Gefitinib as a third line compassionate treatment of NSCLC.
Results: We enrolled 37 patients (29 men, 8 women). Tumors included 25 adenocarcinoma, 4 squamous cell carcinoma, 7 large cell carcinoma, and 1 neuroendocrine carcinoma. Partial response rate was 8.1%, and stable disease rate 27.0%. The 3 responders were all non-smoker women, with an histological type of adenocarcinoma. Symptoms improvement was observed in 59.5% of patients. Main toxicities were diarrhoea and skin reactions. We observed that responding patients had more adverse drugs-related reactions than stable or non-responding patients.
Conclusions: Gefitinib is a meaningful active therapy in NSCLC with a favorable toxicity profile. We suggest that being a woman, a never-smoker and having an adenocarcinoma may be clinical predictive factors of response to Gefitinib.