Combination therapy improves progression-free survival in RCC

January 4, 2007

Bevacizumab (Avastin) in combination with interferon alfa-2a (Roferon-A) therapy in patients with first-line metastatic renal cell carcinoma appears to significantly improve progression-free survival compared with interferon alfa-2a therapy alone, according to recent findings from an unpublished interim analysis of phase III data.

Bevacizumab (Avastin) in combination with interferon alfa-2a (Roferon-A) therapy in patients with first-line metastatic renal cell carcinoma appears to significantly improve progression-free survival compared with interferon alfa-2a therapy alone, according to recent findings from an unpublished interim analysis of phase III data. In addition, the analysis indicates a trend toward improvement in overall survival in patients receiving bevacizumab plus interferon.
 
The double-blind trial enrolled 649 patients with first-line metastatic RCC. Patients were randomized to receive either standard therapy of interferon plus placebo or interferon plus bevacizumab, 10 mg/kg administered every 2 weeks. The primary analysis endpoint was improvement in progression-free survival. Other endpoints included overall survival, time to progression, time to treatment failure, overall response rate, and safety profile.

Adverse events in the study appeared to be similar to those previously reported for interferon and for bevacizumab. The most common adverse events in the bevacizumab plus interferon arm included bleeding, hypertension, and proteinuria. Serious adverse events occurring more often in the bevacizumab plus interferon arm included fatigue, pneumonia, and gastrointestinal perforations.

The full study results are expected to be released at an upcoming medical meeting. Bevacizumab is currently FDA-approved for the treatment of metastatic colon or rectal cancer.