|
|||||
|
|
||||||
Journal of Clinical Oncology, Vol 25, No 22 (August 1), 2007: pp. 3288-3295 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.10.8613 Phase II Trial of Sorafenib Plus Interferon Alfa-2b As First- or Second-Line Therapy in Patients With Metastatic Renal Cell Cancer
From the Division of Medical Oncology, Department of Medicine, and Departments of Biostatistics and Bioinformatics, Duke University Medical Center, Durham; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Investigational Drug Branch, National Cancer Institute, Bethesda, MD Address reprint requests to Jared A. Gollob, MD, Duke University Medical Center, DUMC 3441, Durham, NC 27710; e-mail: jared.gollob{at}duke.edu
Purpose: We undertook this study to determine the activity and tolerability of sorafenib administered with interferon alfa-2b (IFN-
Patients and Methods: Between November 2004 and October 2006, 40 patients at two sites were enrolled onto a phase II trial of sorafenib plus IFN- Results: The response rate was 33% (95% CI, 19% to 49%; 13 of 40 patients), including 28% partial responses (n = 11) and 5% complete responses (n = 2). Responses were seen in treatment-naïve and interleukin-2 (IL-2) –treated patients within the first two cycles. The median duration of response was 12 months. With a median follow-up time of 14 months, median progression-free survival time was 10 months (95% CI, 8 to 18 months), and median overall survival time has not yet been reached. Fatigue, anorexia, anemia, diarrhea, hypophosphatemia, rash, nausea, and weight loss were the most common toxicities. Grade 3 toxicities were uncommon but included hypophosphatemia, neutropenia, rash, fatigue, and anemia. Dose reductions were required in 65% of patients.
Conclusion: The combination of sorafenib and IFN- Supported by National Institutes of Health Grants No. K23RR15541 and U01-CA-099118. Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA, and the 3rd International Congress on Kidney and Bladder Cancer, August 4-6, 2006, Orlando, FL. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. This article has been cited by other articles:
|
||||||||||||||||||||||||
|
|||||||||||
|
Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|