Originally published as JCO Early Release 10.1200/JCO.2008.19.3342 on January 26 2009

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Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma

From the Institut Gustave Roussy, Villejuif; Centre René Gauducheau, Nantes; and Centre Léon Bérard, Lyon, France; Department of Oncology, Military Medical Institute; and Klinika Nowotworów Ukladu Moczowego, Warsaw, Poland; Universitätsklinikum Großhadern, Munich; and Bayer Vital, Leverkusen, Germany; Baylor-Sammons/Texas Oncology, Dallas, TX; Evanston Northwestern Healthcare, Center on Outcomes Research and Education, Evanston, IL; Bayer HealthCare Pharmaceuticals, Montville, NJ; and Cleveland Clinic Cancer Center, Cleveland, OH.

Corresponding author: Bernard Escudier, MD, Institut Gustave Roussy, 39 Rue Camille Desmoulins, 94805, Villejuif, France; e-mail: escudier{at}igr.fr.

Purpose An open-label, phase II study to evaluate progression-free survival (PFS), overall best response, adverse events (AEs), and patient-reported outcomes with sorafenib versus interferon alfa-2a (IFN--2a) in patients with untreated, advanced renal cancer.

Patients and Methods A total of 189 patients were randomly assigned to oral sorafenib 400 mg twice daily or to subcutaneous IFN--2a 9 million U three times weekly (period 1). Sorafenib patients who progressed were dose-escalated to 600 mg twice daily; IFN--2a patients who progressed were switched to sorafenib 400 mg twice daily (period 2).

Results In period 1 PFS was similar for sorafenib-treated (n = 97; 5.7 months) and IFN--2a–treated patients (n = 92; 5.6 months); more sorafenib-treated patients had tumor shrinkage (68.2% v 39.0%). Common drug-related AEs (Grades 3) for sorafenib were hand-foot skin reaction (11.3%), diarrhea (6.2%), and rash/desquamation (6.2%); for IFN--2a, these were fatigue (10.0%), nausea (3.3%), flu-like syndrome (2.2%), and anorexia (2.2%). Sorafenib-treated patients reported fewer symptoms, better quality of life (QOL), and greater treatment satisfaction. In period 2, 41.9% of patients who received sorafenib 600 mg twice daily (n = 43) experienced tumor reduction (median PFS, 3.6 months). After the switch to sorafenib 400 mg twice daily, tumors were reduced in 76.2% of 50 patients (median PFS, 5.3 months). AEs were mostly grade 1 to 2; no increase in AEs of grades 3 occurred after sorafenib dose escalation.

Conclusion In this study, sorafenib resulted in similar PFS as IFN--2a in patients with untreated RCC. However, sorafenib-treated patients experienced greater rates of tumor size reduction, better QOL, and improved tolerability. Both dose escalation of sorafenib after progression and a switch to sorafenib after progression on IFN--2a resulted in clinical benefit.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00117637 [ClinicalTrials.gov] .

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006 Atlanta, GA; the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL.

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