Gefitinib in heavily pretreated non small cell lung cancer: Results of the expanded access program in Eastern France

Abstract

7323 Background: Patients with NSCLC usually present or relapse with metastatic or unresectable disease resistant to standard therapy. Gefitinib is an orally active, selective tyrosine kinase inhibitor targeting the EGFR. Two large phase II monotherapy trials (IDEAL)-1 & (IDEAL)-2 have established Iressa as an effective therapy for NSCLC pts having failed chemotherapy (Cx). The present study evaluates the efficacy and safety of Iressa for pts treated through an EAP in Eastern France. Methods: pts were eligible if they had histologically proven NSCLC and had failed two or more prior Cx regimens at least one of which was platinum based. All patients gave written informed consent. Gefitinib was given 250 mg od. Therapies other than supportive care were not permitted. All patients were prospectively followed with monthly clinical examination, blood tests and chest X-ray. Results: 82 pts were eligible in 6 centers. Median age was 58 yrs (range, 34–79) with 49/33 M/F. Histological subtypes were epidermoid (21%), adenocarcinoma (67%) and other (12%). Median WHO PS was 2 (range, 0–4). The number of previous Cx regimens was 2 (35pts), 3 (36 pts), 4 or more (11 pts). 16 patients were not evaluable for response due to early death or insufficient follow-up. Among the 66 evaluable pts 3 PR were observed (4.5%), 26 pts experienced SD (39.4%) and 37 progressed, for a clinical benefit (PR + SD) in 43.9% of pts. Toxicity was mild with mostly grade1–2 diarrhoea, grade 1 xerodermia and grade 1–2 acneiform rash. No cases of interstitial pneumonia were suspected. Median duration of treatment was 2 mo (range, 0–11), 30 pts usually with poor PS having been treated for 1 mo or less. Median survival was 3 mo (range, 0.0–15+). Conclusion: Our results are similar to those reported in the global monotherapy trials IDEAL 1 & 2 with a disease control rate (including both tumor response and stable disease) of 44%. Our lower response rate (4.5% versus 19% for IDEAL 1) could be due to the fact that many pts were treated at a very advanced stage of disease, 30 could not complete more than one month of Iressa. This urges for an earlier use of Iressa in the course of the disease. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca AstraZeneca