Drug combination shows significant survival advantage in metastatic RCC

The combination of bevacizumab (Avastin) and interferon-alpha (Roferon-A) as first-line treatment in patients with metastatic renal cell carcinoma offers significant improvement in progression-free survival compared with interferon-alpha alone, according to a study published in The Lancet (2007; 370:2103-11).

Bernard Escudier, MD, of the Institut Gustave Roussy, Villejuif, France, and colleagues conducted a multicenter, randomized, double-blind, phase III trial of 649 patients with previously untreated metastatic RCC. Patients were randomized to receive interferon-alpha and bevacizumab or placebo and interferon-alpha.

In all, 325 patients in the bevacizumab plus interferon alpha group and 316 in the placebo plus interferon-alpha group received at least one dose of treatment. At the time of unblinding, 230 progression events had occurred in the bevacizumab plus interferon-alpha group and 275 in the control group; there were 114 deaths in the bevacizumab plus interferon alpha group and 137 in the control group. Median duration of progression-free survival was significantly longer in the bevacizumab plus interferon-alpha group than in the control group (10.2 months vs. 5.4 months; p=.0001).

Increases in progression-free survival were seen with bevacizumab plus interferon-alpha irrespective of risk group or whether reduced-dose interferon-alpha was received. Deaths due to adverse events were reported in eight patients who received one or more doses of bevacizumab and seven of those who did not receive the drug. Only three deaths in the bevacizumab arm were considered by investigators to be possibly related to bevacizumab. The most commonly reported adverse events were fatigue and asthenia.