Phase II Trial of Sorafenib Plus Interferon Alfa-2b As First- or Second-Line Therapy in Patients With Metastatic Renal Cell Cancer

We undertook this study to determine the activity and tolerability of sorafenib administered with interferon alfa-2b (IFN-alpha-2b) as first- or second-line therapy in metastatic renal cell cancer (RCC). Between November 2004 and October 2006, 40 patients at two sites were enrolled onto a phase II t...

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Bibliographic Details
Published in:	Journal of clinical oncology Vol. 25; no. 22; pp. 3288 - 3295
Main Authors:	GOLLOB, Jared A, KIMRYN RATHMELL, W, RICHMOND, Tina M, MARINO, Christine B, MILLER, Elizabeth K, GRIGSON, Gayle, WATKINS, Catharine, LIN GU, PETERSON, Bercedis L, WRIGHT, John J
Format:	Journal Article
Language:	English
Published:	Baltimore, MD American Society of Clinical Oncology 01-08-2007 Lippincott Williams & Wilkins
Subjects:	Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Benzenesulfonates - administration & dosage Benzenesulfonates - adverse effects Biological and medical sciences Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - secondary Female Humans Interferon-alpha - administration & dosage Interferon-alpha - adverse effects Kidney Neoplasms - drug therapy Kidney Neoplasms - pathology Kidneys Magnetic Resonance Imaging Male Medical sciences Middle Aged Nephrology. Urinary tract diseases Niacinamide - analogs & derivatives North Carolina Phenylurea Compounds Pyridines - administration & dosage Pyridines - adverse effects Recombinant Proteins Tomography, X-Ray Computed Treatment Outcome Tumors Tumors of the urinary system Kidney disease Antineoplastic agent Human Urinary system disease Carcinoma Alpha interferon Malignant tumor Metastasis First line treatment Cancerology Sorafenib Kidney cancer Phase II trial Grawitz tumor Advanced stage Second line treatment Interferon alfa
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Summary:	We undertook this study to determine the activity and tolerability of sorafenib administered with interferon alfa-2b (IFN-alpha-2b) as first- or second-line therapy in metastatic renal cell cancer (RCC). Between November 2004 and October 2006, 40 patients at two sites were enrolled onto a phase II trial of sorafenib plus IFN-alpha-2b. Treatment consisted of 8-week cycles of sorafenib 400 mg orally bid plus IFN-alpha-2b 10 million U subcutaneously three times a week followed by a 2-week break. Patients were eligible to receive additional cycles of therapy until disease progression. Dose reduction of both drugs by 50% was permitted once for toxicity. 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. The combination of sorafenib and IFN-alpha-2b has substantial activity in treatment-naïve and IL-2-treated patients with RCC. The toxicity exceeded that of either drug alone, but dose reductions and breaks between cycles allowed for chronic therapy. A larger, randomized trial would determine whether there is any advantage to this regimen compared with sorafenib alone.
ISSN:	0732-183X 1527-7755
DOI:	10.1200/JCO.2007.10.8613