Prognostic factors for progression-free and overall survival with sunitinib targeted therapy and with cytokine as first-line therapy in patients with metastatic renal cell carcinoma — Ann Oncol

Ann Oncol (2011) 22 (2): 295-300.
doi: 10.1093/annonc/mdq342
First published online: July 25, 2010


Prognostic factors for progression-free and overall survival with sunitinib targeted therapy and with cytokine as first-line therapy in patients with metastatic renal cell carcinoma
S. Patil1,*, R. A. Figlin2, T. E. Hutson3, M. D. Michaelson4, S. Négrier5, S. T. Kim6, X. Huang6 and R. J. Motzer7

+ Author Affiliations
1Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY
2Division of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA
3Genitourinary Oncology Program, Baylor Sammons Cancer Center-Texas Oncology, P.A., Dallas, TX
4Hematology/Oncology, Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA, USA
5Department of Medical Oncology and Cytokines & Cancer Research Unit, Centre Léon Bérard, Lyon, France
6Clinical Development, Pfizer Oncology, La Jolla, CA
7Genitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA


*Correspondence to: Dr S. Patil, Department of Biostatistics, Epidemiology and Statistics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. Tel: +1-646-735-8182; Fax: +1-646-735-0010; E-mail: patils@mskcc.org

Received January 28, 2010.
Revision received April 12, 2010.
Accepted May 17, 2010.


Abstract
Background: Analysis of prognostic factors for progression-free survival (PFS) and overall survival (OS) was performed using final data from a randomized phase III trial of sunitinib versus interferon-α (IFN-α) as first-line metastatic renal cell carcinoma (RCC) therapy.
Design: A multivariate Cox regression model analyzed baseline variables for prognostic significance. Each variable was investigated univariately and then multivariately using a stepwise algorithm.

Results: Each treatment arm comprised 375 patients. For sunitinib, multivariate analysis of PFS identified five independent predictors, including serum lactate dehydrogenase (LDH) level, presence of ≥2 metastatic sites, no prior nephrectomy, Eastern Cooperative Oncology Group (ECOG) performance status, and baseline platelet count, while multivariate analysis of OS identified serum LDH level, corrected serum calcium level, time from diagnosis to treatment, hemoglobin level, ECOG performance status, and presence of bone metastasis as predictors. For IFN-α, LDH level and presence of ≥2 metastatic sites were common predictors of PFS to those for sunitinib, as were all predictors of OS except ECOG status.

Conclusions: This analysis identified prognostic factors for PFS and OS with sunitinib as first-line metastatic RCC therapy and confirmed that the Memorial Sloan-Kettering Cancer Center model is applicable in the era of targeted therapy.


Prognostic factors for progression-free and overall survival with sunitinib targeted therapy and with cytokine as first-line therapy in patients with metastatic renal cell carcinoma — Ann Oncol