AVOREN: Bevacizumab plus interferon extended OS in metastatic renal cell carcinoma

Phase-3 results from the AVOREN trial showed that the combination of bevacizumab and interferon alfa-2a improved OS as first-line therapy in patients with metastatic renal cell carcinoma.

These results update findings presented at the 2007 and 2008 ASCO Annual Meetings detailing the safety of the combination and its beneficial effect on PFS.

From June 2004 to October 2005, researchers randomly assigned 649 previously untreated patients to bevacizumab (Avastin, Genentech) plus interferon alfa-2a (n=327) or interferon alfa-2a plus placebo (n=322). The clinical cutoff for the final analysis of OS was September 2008, after 220 deaths had occurred in the combination arm and 224 deaths had occurred in the control arm.

Median follow-up was 23 months in the study arm and 21 months in the control arm.

Median OS in the study arm was 23.3 months vs. 21.3 months in the control arm (HR=0.91; 95% CI, 0.76-1.10).

Stratified analysis by Memorial Sloan-Kettering Cancer Center risk and region showed an even stronger improvement in OS in the study arm (HR=0.86; 95% CI, 0.72-1.04). Researchers observed a similar HR after they censored the 13 patients in the control arm who crossed over to bevacizumab plus interferon alfa-2a when the trial was unblinded (HR=0.84; 95% CI, 0.7-1.02).

A prespecified multiple Cox regression model indicated that several baseline prognostic factors such as white blood cell count and Motzer score were associated with survival independent of treatment. Adjustment for these baseline factors indicated a 22% reduction in the risk for death for patients in the combination arm compared with the control arm (HR=0.78; 95% CI, 0.63-0.96).

Escudier B. J Clin Oncol. 2010;doi:10.1200/JCO.2009.26.7849.