Final results of the phase III, randomized, double-blind AVOREN trial of first-line bevacizumab (BEV) + interferon-α2a (IFN) in metastatic renal cell carcinoma (mRCC)

Carolyn Vachani, RN, MSN, AOCN
Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 8, 2009

Title: Final results of the phase III, randomized, double-blind AVOREN trial of first-line bevacizumab (BEV) + interferon-α2a (IFN) in metastatic renal cell carcinoma (mRCC)
Reviewer: Geoffrey Geiger, MD
Author(s): B. J. Escudier, J. Bellmunt, S. Negrier, B. Melichar, S. Bracarda, A. Ravaud, S. Golding, S. Jethwa, on behalf of the AVOREN Investigators.
Affiliations: Institut Gustave Roussy, Villejuif, France; University Hospital del Mar, Barcelona, Spain; Centre LŽon BŽrard, Lyon, France; Palackż University Medical School , Olomouc, Czech Republic; Medical Oncology, Perugia, Italy; Hōpital Saint AndrŽ, CHU, Bordeaux, France; F. Hoffmann-La Roche, Basel, Switzerland

Metastatic renal cell carcinoma has proven to be resistant to conventional chemotherapy, and has thus typically been treated with immunotherapy and the newer targeted therapies (sorafenib, sunitinib). This report summarizes the final results of the AVOREN trial, which compared interferon alfa2a with or without bevacizumab, a monoclonal antibody that inhibits angiogenesis. In the original reporting of the AVOREN trial, bevacizumab plus interferon was demonstrated to significantly improve progression free survival, as compared to placebo plus interferon, in patients with mRCC (Escudier, Lancet. 2007).

The bevacizumab group had a statistically significant (SS) advantage in progression free survival (10.4 vs. 5.5 months) and response rate (31% vs. 12%). However, this did not translate into a SS advantage in overall survival (23.3 vs. 21.3 months, p=0.1291).

The bottom line is, these results do not exceed those of sunitinib, with an OS of 26.4 months. Therefore, although bevacizumab and interferon represent a reasonable approach to the treatment of mRCC, there is no compelling reason to select this regimen over interferon plus sunitinib, where at ASCO 2008, the objective response rate was reported as 47% in the sunitinib arm versus 12% in the interferon group (P<0.000001) and median overall survival was 26.4 months for sunitinib-treated patients versus 21.8 months (P=0.051).

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