Authors' objectives:

This report is intended to assess the efficacy of Gefitinib for the treatment non-small-cell Lung carcinoma (NSCLC) and to determine the validated indications for its use.

Authors' results and conclusions: Two Phase II multicentric studies were found (IDEAL-1 and IDEAL-2). Both studies compared 250mg and 500mg daily doses of Gefitinib in patients who received prior chemotherapy treatments. For IDEAL-1, the mean average response was 18% for both treatment groups, whereas for IDEAL-2, the mean response was 10%. In both studies, approximately 40% of the patients improved their symptoms two weeks after treatment. None of these studies showed significant differences between both Gefinitib doses, but a higher number of adverse events were observed at 500 mg/daily. Based on these data, although the studies were not compared against placebo, Japan approved the use of Gefitinib in 2002 and Food and Drug Administration (FDA) in May 2003 as third line chemotherapy treatment for advanced NSCLC, after failure to platinum and docetaxel-based regimens. Two Phase III studies were carried out to assess whether Gefitinib should be added to first and second line chemotherapy treatments. An increase in overall survival was not observed, nor an increased response in any of the studies. In a sub-group analysis, a better response was observed in patients with adenocarcinomas, bronchoalveolar carcinomas and in women. The number of prior chemotherapy treatments and the general condition of the patient were not predictors of improvement. In December 2004, Astra Zeneca, Gefinitib manufacturer, published the results of a Phase III study which enrolled 1692 patients with NSCLC who had failed one or two other chemotherapy regimens and were randomized to receive either Gefitinib 250mg or placebo. This study did not show a significant increase in survival in the Gefitinib treated group Hazard Ratio 0.89 p=0.11, with a mean survival of 5.6 vs 5.1 months), nor in the adenocarcinoma sub-group (HR0.83 p=0.07, with a mean survival 6.3 vs 5.4 months).

Authors' recommendations: The development of epidermal growth factor receptor (EGFR) selective tyrosine kinase inhibitors, Gefitinib and Erlotinib, has opened a line of study to improve the treatment of patients with advanced stages of NSCLC who have failed standard chemotherapy regimens. However, in the light of the latest published results, there are no reasons to use Gefitinib for the treatment of patients in whom drug response has not previously been demonstrated.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)