Bevacizumab Plus Interferon Alfa Compared With Interferon Alfa Monotherapy in Patients With Metastatic Renal Cell Carcinoma: CALGB 90206

Author:

Rini Brian I.1,Halabi Susan1,Rosenberg Jonathan E.1,Stadler Walter M.1,Vaena Daniel A.1,Ou San-San1,Archer Laura1,Atkins James N.1,Picus Joel1,Czaykowski Piotr1,Dutcher Janice1,Small Eric J.1

Affiliation:

1. From the Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; Department of Biostatistics and Bioinformatics, Duke University Medical Center, and Cancer and Leukemia Group B Statistical Center, Durham; Southeast Cancer Control Consortium Inc, Winston-Salem, NC; University of California at San Francisco, San Francisco, CA; University of Chicago Medical Center, Chicago, IL; University of Iowa, Iowa City, IA; Washington University, St Louis, MO; CancerCare Manitoba, Winnipeg, Manitoba, and the National...

Abstract

PurposeBevacizumab is an antibody that binds to vascular endothelial growth factor (VEGF) and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN) is a historic standard first-line treatment for RCC. A prospective, randomized phase III trial of bevacizumab plus IFN versus IFN monotherapy was conducted.Patients and MethodsPatients with previously untreated, metastatic clear-cell RCC were randomly assigned to receive either bevacizumab (10 mg/kg intravenously every 2 weeks) plus IFN (9 million U subcutaneously three times weekly) or the same dose and schedule of IFN monotherapy in a multicenter phase III trial. The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), objective response rate (ORR), and safety.ResultsBetween October 2003 and July 2005, 732 patients were enrolled. The prespecified stopping rule for OS has not yet been reached. The median PFS was 8.5 months in patients receiving bevacizumab plus IFN (95% CI, 7.5 to 9.7 months) versus 5.2 months (95% CI, 3.1 to 5.6 months) in patients receiving IFN monotherapy (log-rank P < .0001). The adjusted hazard ratio was 0.71 (95% CI, 0.61 to 0.83; P < .0001). Bevacizumab plus IFN had a higher ORR as compared with IFN (25.5% [95% CI, 20.9% to 30.6%] v 13.1% [95% CI, 9.5% to 17.3%]; P < .0001). Overall toxicity was greater for bevacizumab plus IFN, including significantly more grade 3 hypertension (9% v 0%), anorexia (17% v 8%), fatigue (35% v 28%), and proteinuria (13% v 0%).ConclusionBevacizumab plus IFN produces a superior PFS and ORR in untreated patients with metastatic RCC as compared with IFN monotherapy. Toxicity is greater in the combination therapy arm.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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