Authors' objectives:

This report is intended to assess the efficacy of Erlotinib for the management of advanced non-small-cell lung carcinoma (NSCLC) and to determine its validated indications.

Authors' results and conclusions: Two non-controlled phase II studies showed some response (reduction in the tumor size) between 12.3% and 25% in patients with NSCLC and who had negative response to regular chemotherapies. The best response was observed in the study of Perez Soler et al including only patients with bronchoalveolar carcinoma, a subtype likely to be more sensitive to this group of drugs. Two randomized controlled phase III studies were carried out to assess if erlotinib should be added to first-line and second-line chemotherapy regimes (TRIBUTE and TALENT). There was no increase in the survival, nor in the response in any of the two studies which compared erlotinib against placebo. A TRIBUTE study subgroup analysis showed a higher response in the non-smoking patient group (30% vs 11%). There was also an increase in survival in this patient subgroup. In another recently published phase III study 731 patients were randomized with stage IIIb or IV SNCLC to one or two chemotherapy regimes prior to receiving 150mg erlotinib orally or placebo. The response was 8.9% in the erlotinib group versus 1% in the placebo group with an average effect of 4.2 months higher in the erlotinib group. The overall survival observed was higher in the erlotinib group with a statistically significant difference of 2 months when compared against placebo. Women, non smokers, Asians, patients with adenocarcinoma and patients with more than 10% expression of epidermal growth factor receptor (EGFR) showed better responses. These study findings made the Food & Drug Administration (FDA) accept erlotinib in November, 2004. The presence of EGFR mutations has not proved to be erlotinib response predictor in phase III studies and its role in screening of patients eligible for the treatment is still to be determined. Rash and diarrhea are the most common adverse effects. A higher number of patients with pulmonar fibrosis has not been reported as it has been in the case of Gefitinib, another drug belonging to the same class.

Authors' recommendations: Erlotinib has proved to increase survival in patients with locally advanced or metastatic NSCLC where conventional chemotherapy regimens have failed. Non-smokers, women, Asians, patients with adenocarcinoma and with more than 10% of cells with expression of EGFR would be the best candidates for this treatment. It has not been proved to be effective as first line therapy.

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)