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 Pizzocaro, G. Articles by Marubini, E. Search for Related Content PubMed PubMed Citation Articles by Pizzocaro, G. Articles by Marubini, E. Social Bookmarking                            What's this?

Interferon Adjuvant to Radical Nephrectomy in Robson Stages II and III Renal Cell Carcinoma: A Multicentric Randomized Study

From the Division of Urology, Department of Surgery, Division of Medical Statistics and Biometry, and Division of Human Tumors Immunotherapy, Department of Experimental Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori; and Institute of Medical Statistics and Biometry, University of Milan, Milan, Italy.

Address reprint requests to Giorgio Pizzocaro, MD, Urology Division, Department of Surgery, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy; email pizzocaro{at}istitutotumori.mi.it

PURPOSE: Because interferon gave promising results in the management of metastatic renal cell carcinoma in the 1980s, a multicentric randomized controlled trial was planned to compare adjuvant recombinant interferon alfa-2b (rIFN2b) with observation after radical nephrectomy in patients with Robson stages II and III renal cell carcinoma. Overall and event-free survival were to be evaluated together with prognostic factors.

PATIENTS AND METHODS: Overall and event-free survival curves for 247 patients (124 controls and 123 treated) were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox’s multiple regression models were adopted to perform a joint analysis of treatment and prognostic factors.

RESULTS: The 5-year overall and event-free survival probabilities were 0.665 and 0.671, respectively, for controls and 0.660 and 0.567, respectively, for the treated group; the differences were not statistically significant (2P = .861 for overall and 2P = .107 for event-free survival with the log-rank test). Regarding prognostic factors, only grade, pT, and pN demonstrated a significant prognostic role. First-order interactions of treatment with pT and pN category were investigated; a significant interaction was found between pN and treatment. A harmful effect of rIFN2b in the 97 treated pN0 patients and a protective effect in the 13 treated pN2/pN3 patients were statistically significant.

CONCLUSION: Adjuvant rIFN2b is not indicated after radical nephrectomy for renal cell carcinoma. The protective effect in the small group of pN2/pN3 patients requires further investigation.

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

This article has been cited by other articles:

				J. M.G. Larkin, E. L.S. Kipps, C. J. Powell, and C. Swanton Review: Systemic therapy for advanced renal cell carcinoma Therapeutic Advances in Medical Oncology, July 1, 2009; 1(1): 15 - 27. [Abstract] [PDF]

				B. I. Rini Metastatic Renal Cell Carcinoma: Many Treatment Options, One Patient J. Clin. Oncol., July 1, 2009; 27(19): 3225 - 3234. [Abstract] [Full Text] [PDF]

				C. G. Wood Multimodal Approaches in the Management of Locally Advanced and Metastatic Renal Cell Carcinoma: Combining Surgery and Systemic Therapies to Improve Patient Outcome Clin. Cancer Res., January 15, 2007; 13(2): 697s - 702s. [Abstract] [Full Text] [PDF]

				J. Vardy and I. F. Tannock Quality of cancer care Ann. Onc., July 1, 2004; 15(7): 1001 - 1006. [Abstract] [Full Text] [PDF]

				J. I. Clark, M. B. Atkins, W. J. Urba, S. Creech, R. A. Figlin, J. P. Dutcher, L. Flaherty, J. A. Sosman, T. F. Logan, R. White, et al. Adjuvant High-Dose Bolus Interleukin-2 for Patients With High-Risk Renal Cell Carcinoma: A Cytokine Working Group Randomized Trial J. Clin. Oncol., August 15, 2003; 21(16): 3133 - 3140. [Abstract] [Full Text] [PDF]

				P. Indolfi, M. Terenziani, F. Casale, M. Carli, G. Bisogno, A. Schiavetti, A. Mancini, R. Rondelli, A. Pession, A. Jenkner, et al. Renal Cell Carcinoma in Children: A Clinicopathologic Study J. Clin. Oncol., February 1, 2003; 21(3): 530 - 535. [Abstract] [Full Text] [PDF]

				A. Zisman, A. J. Pantuck, J. Wieder, D. H. Chao, F. Dorey, J. W. Said, J. B. deKernion, R. A. Figlin, and A. S. Belldegrun Risk Group Assessment and Clinical Outcome Algorithm to Predict the Natural History of Patients With Surgically Resected Renal Cell Carcinoma J. Clin. Oncol., December 1, 2002; 20(23): 4559 - 4566. [Abstract] [Full Text] [PDF]

				D. L. Brassard, M. J. Grace, and R. W. Bordens Interferon-{alpha} as an immunotherapeutic protein J. Leukoc. Biol., April 1, 2002; 71(4): 565 - 581. [Abstract] [Full Text] [PDF]

				I. F. Tannock Removing the Primary Tumor after the Cancer Has Spread N. Engl. J. Med., December 6, 2001; 345(23): 1699 - 1700. [Full Text] [PDF]