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%)...