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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.

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