This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Aass, N. Articles by Sylvester, R. J. Search for Related Content PubMed PubMed Citation Articles by Aass, N. Articles by Sylvester, R. J. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Hazardous Substances DB 13-CIS-RETINOIC ACID Medline Plus Health Information Kidney Cancer Social Bookmarking                            What's this?

Randomized Phase II/III Trial of Interferon Alfa-2a With and Without 13-cis-Retinoic Acid in Patients With Progressive Metastatic Renal Cell Carcinoma: The European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951)

From the Department of Clinical Cancer Research, The Norwegian Radium Hospital, Oslo, Norway; Departments of Internal Medicine and Urology, University Medical Centre Nijmegen, Nijmegen; Department of Urology, Erasmus Medical Center, Rotterdam, the Netherlands (current address: Centrum Fuer Operative Urologie Bremen, Bremen, Germany); Department of Oncology, U.Z. Gasthuisberg; Department of Urology, U.Z. Gasthuisberg, Leuven; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium

Address reprint requests to Nina Aass, MD, PhD, The Norwegian Radium Hospital, 0310 Oslo, Norway; e-mail: ninaaass{at}radium.uio.no

PURPOSE: A randomized phase II/III trial was conducted to determine whether combination treatment with 13-cis-retinoic acid (13-CRA) plus interferon alfa-2a (IFN--2a) was superior to IFN--2a alone in patients with progressive metastatic renal cell carcinoma.

PATIENTS AND METHODS: Three hundred twenty patients were randomly assigned to treatment with IFN--2a plus 13-CRA or to IFN--2a alone. IFN--2a was given daily subcutaneously, starting at a dose of 3 million units (MU). The dose was escalated every 7 days from 3 to 9 MU by increments of 3 MU. Patients randomly assigned to combination therapy received oral 13-CRA 1 mg/kg/d plus IFN--2a.

RESULTS: Median time to progression was 5.1 months for patients treated with the combination and 3.4 months for patients on IFN--2a alone (P = .008). Progression-free survival rates at 6 months were 43% for patients receiving combined therapy and 30% for patients on IFN--2a, and at 12 months, 27% and 17%, respectively. Median overall survival was 17.3 months for patients on IFN--2a and 13-CRA, and 13.2 months for patients treated with IFN--2a (P = .048). Twenty-two percent of the patients receiving the combination stopped treatment due to toxicity, as compared with 16% on IFN--2a.

CONCLUSION: Progression-free and overall survival for patients with progressive metastatic renal cell carcinoma treated with IFN--2a plus 13-CRA were significantly longer compared with patients on IFN--2a alone (P = .007 and P = .048, respectively). Improvement in efficacy in the combination arm was accompanied by increased, though not serious, toxicity.

Supported by an Educational Grant from Hoffman-La Roche and grant Nos. 2U10 CA11488-25 through 5U10 CA11488-34 from the National Cancer Institute (Bethesda, MD).

This article’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				G. Hudes, M. Carducci, P. Tomczak, J. Dutcher, R. Figlin, A. Kapoor, E. Staroslawska, J. Sosman, D. McDermott, I. Bodrogi, et al. Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma N. Engl. J. Med., May 31, 2007; 356(22): 2271 - 2281. [Abstract] [Full Text] [PDF]

				M. Parton, M. Gore, and T. Eisen Role of Cytokine Therapy in 2006 and Beyond for Metastatic Renal Cell Cancer J. Clin. Oncol., December 10, 2006; 24(35): 5584 - 5592. [Abstract] [Full Text] [PDF]