Authors' objectives:

The aim of this report was to assess the effectiveness of cetuximab for the management of advanced colorectal cancer.

Authors' results and conclusions: Two Phase II studies were found which assessed the efficacy and safety of Cetuximab in patients with advanced colorectal cancer (CRC). There was a 19% response in the study using Cetuximab combined with Irinotecan and 11% when monotherapy was used. In a study including 329 randomized patients to receive Cetuximab alone or combined with irinotecan, the rate of response was 10% in the monotherapy group and 22.9% in the combination group, showing a statistically significant difference. The average disease progression time was 4.1 months in the combination group and 1.5 months in the monotherapy group with a progression Relative Risk (RR) of 0.54 for the combination group (CI 95% 0.42-0.71), but the average survival was similar for both groups. The extent of epidermal growth factor receptor (EGFR) expression did not correlate with the clinical response (p=0.54), although, in the subgroup analysis, the response was higher in patients with severe acne-like rash, attributable to EGFR inhibition (p=0.005). The results of the study led to the Cetuximab approval by the FDA in 2004, as second-line treatment for advanced CRC. The cost per patient treated with Cetuximab only, is approximately $21,600-$27,600 (Argentine pesos October, 2005), thus making it necessary for our health system organizations to assess the usefulness of this drug versus its cost.

Authors' recommendations: Without chemotherapy, the average survival in patients with advanced CRC is 6 months, after the use of 5-fluorouracil (5FU), Irinotecan and Oxaliplatin this survival extended to 21 months though these new drugs have tripled the cost of treatment in these patients. Even though Cetuximab has shown some benefits in some disease clinical control parameters, it has not been already proven that it can improve survival; however, it is covered by some United States health organizations. Despite a higher number of therapeutic choices, the treatment of advanced CRC still remains palliative, with no evidence that new therapies can increase cure rate. The high cost of the new treatments forces to critically assess their results as regards resources available in health organizations.

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)