title: Inhibition of EGFR tyrosine-kinase in NSCLC treatment: the Hungarian experience with gefitinib in the context of an expanded access programme.
abstract: The ZD1839 (Iressa, gefitinib) treatment in phase I trials for patients with advanced non-small cell lung cancer (NSCLC) was associated with disease stabilization and tumor regression. The aim of this study was to analyze the efficacy of gefitinib monotherapy as a second- or third-line treatment for locally-advanced and advanced NSCLC. Data for 50 patients were analyzed. Patients were treated at 5 centers in Hungary as part of the gefitinib Expanded Access Programme (EAP). The response rate was 10% (all partial responses), with disease stabilization in 46% of patients. Disease progression was observed in 44% of patients. The median survival according to the Kaplan-Meier method was 8 months. Median survival of patients with adenocarcinoma was significantly increased compared with squamous cell carcinoma and, of the patients responding to therapy, 80% had adenocarcinoma. The 1-year survival rate was 34%. All patients were evaluable for safety; the adverse events seen with gefitinib were generally mild and only two patients had to be withdrawn from the study due to adverse events. The Hungarian experience suggests gefitinib therapy is effective and well tolerated.
authors.affiliation: National Koranyi Institute of Pulmonology, H-1529, 1 Piheno út, Budapest, Hungary.
authors.forename: Gyula
authors.initials: G
authors.lastname: Ostoros
authors.forename: Revekka
authors.initials: R
authors.lastname: Harisi
authors.forename: Gabor
authors.initials: G
authors.lastname: Kovacs
authors.forename: Jozsef
authors.initials: J
authors.lastname: Horti
authors.forename: Lajos
authors.initials: L
authors.lastname: Geczi
authors.forename: Klara
authors.initials: K
authors.lastname: Szondy
authors.forename: Marta
authors.initials: M
authors.lastname: Orosz
authors.forename: Eniko
authors.initials: E
authors.lastname: Ferenczi
authors.forename: Eva
authors.initials: E
authors.lastname: Ruby
authors.forename: Balazs
authors.initials: B
authors.lastname: Dome
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology*; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib