Erlotinib for the management of advanced lung cancer

AUGUSTOVSKI, F; PICHON-RIVIERE A,; ALCARAZ A; BARDACH, ARIEL; FERRANTE, D; GARCIA MARTÍ, SEBASTIAN; GLUJOVSKY, D; LOPEZ, A; REGUEIRO, A

Documentos de Evaluación de Tecnologías Sanitarias

IECS

Año: 2005 p. 1 - 30

1668-2793

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.A search was started on the main literature databases (MEDLINE, Cochrane, DARE, NHS EED), on the Internet's general search engines, health technology assessment agencies and health sponsors using the following keywords: Lung Neoplasms[Mesh] , erlotinib . Priority was given to including systematic revisions, randomized controlled clinical trials, health technology assessments and financial assessments, clinical practice guidelines and coverage policies from other health systems. Data from local sources on the use of health resources, costs and coverage in Argentina were searched.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.Two coverage policies in the United States were found. CIGNA covers erlotinib for patients with locally advanced or metastatic NSCLC having failed at least one previous conventional chemotherapy regimen. Medicare covers it under the same conditions within the framework of a pilot project.