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Journal of Clinical Oncology, Vol 17, Issue 8 (August), 1999: 2530
© 1999 American Society for Clinical Oncology

Survival and Prognostic Stratification of 670 Patients With Advanced Renal Cell Carcinoma

Robert J. Motzer, Madhu Mazumdar, Jennifer Bacik, William Berg, Alison Amsterdam, Joseph Ferrara

From the Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Cornell University Medical College, New York, NY.

Address reprint requests to Robert J. Motzer, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021

PURPOSE: To identify prognostic factors and a model predictive for survival in patients with metastatic renal-cell carcinoma (RCC).

PATIENTS AND METHODS: The relationship between pretreatment clinical features and survival was studied in 670 patients with advanced RCC treated in 24 Memorial Sloan-Kettering Cancer Center clinical trials between 1975 and 1996. Clinical features were first examined univariately. A stepwise modeling approach based on Cox proportional hazards regression was then used to form a multivariate model. The predictive performance of the model was internally validated through a two-step nonparametric bootstrapping process.

RESULTS: The median survival time was 10 months (95% confidence interval [CI], 9 to 11 months). Fifty-seven of 670 patients remain alive, and the median follow-up time for survivors was 33 months. Pretreatment features associated with a shorter survival in the multivariate analysis were low Karnofsky performance status (<80%), high serum lactate dehydrogenase (> 1.5 times upper limit of normal), low hemoglobin (< lower limit of normal), high "corrected" serum calcium (> 10 mg/dL), and absence of prior nephrectomy. These were used as risk factors to categorize patients into three different groups. The median time to death in the 25% of patients with zero risk factors (favorable-risk) was 20 months. Fifty-three percent of the patients had one or two risk factors (intermediate-risk), and the median survival time in this group was 10 months. Patients with three or more risk factors (poor-risk), who comprised 22% of the patients, had a median survival time of 4 months.

CONCLUSIONS: Five prognostic factors for predicting survival were identified and used to categorize patients with metastatic RCC into three risk groups, for which the median survival times were separated by 6 months or more. These risk categories can be used in clinical trial design and interpretation and in patient management. The low long-term survival rate emphasizes the priority of clinical investigation to identify more effective therapy.


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M. H. T. Bui, D. Seligson, K.-r. Han, A. J. Pantuck, F. J. Dorey, Y. Huang, S. Horvath, B. C. Leibovich, S. Chopra, S.-Y. Liao, et al.
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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
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S. Negrier, B. Escudier, F. Gomez, J.-Y. Douillard, A. Ravaud, C. Chevreau, M. Buclon, D. Perol, and C. Lasset
Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Francais d'Immunotherapie
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G. Bolger, M. S. Copur, P. Ledakis, M. Norvell, J. L. Polo, J. D. Schwartz, and R. C. Flanigan
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J. I. Clark, T. M. Kuzel, T. M. Lestingi, S. G. Fisher, P. Sorokin, B. Martone, M. Viola, and J. A. Sosman
A multi-institutional phase II trial of a novel inpatient schedule of continuous interleukin-2 with interferon {alpha}-2b in advanced renal cell carcinoma: major durable responses in a less highly selected patient population
Ann. Onc., April 1, 2002; 13(4): 606 - 613.
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A. Zisman, A. J. Pantuck, F. Dorey, D. H. Chao, B. J. Gitlitz, N. Moldawer, D. Lazarovici, J. B. deKernion, R. A. Figlin, and A. S. Belldegrun
Mathematical Model to Predict Individual Survival for Patients With Renal Cell Carcinoma
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F. Donskov, H. von der Maase, R. Henriksson, U. Stierner, P. Wersall, H. Nellemann, K. Hellstrand, K. Engman, and P. Naredi
Outpatient treatment with subcutaneous histamine dihydrochloride in combination with interleukin-2 and interferon-{alpha} in patients with metastatic renal cell carcinoma: results of an open single-armed multicentre phase II study
Ann. Onc., March 1, 2002; 13(3): 441 - 449.
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R. J. Motzer, J. Bacik, B. A. Murphy, P. Russo, and M. Mazumdar
Interferon-Alfa as a Comparative Treatment for Clinical Trials of New Therapies Against Advanced Renal Cell Carcinoma
J. Clin. Oncol., January 1, 2002; 20(1): 289 - 296.
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R. J. Motzer, W. Berg, M. Ginsberg, P. Russo, J. Vuky, R. Yu, J. Bacik, and M. Mazumdar
Phase II Trial of Thalidomide for Patients With Advanced Renal Cell Carcinoma
J. Clin. Oncol., January 1, 2002; 20(1): 302 - 306.
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A. Zisman, A. J. Pantuck, F. Dorey, J. W. Said, O. Shvarts, D. Quintana, B. J. Gitlitz, J. B. deKernion, R. A. Figlin, and A. S. Belldegrun
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J. Clin. Oncol., March 15, 2001; 19(6): 1649 - 1657.
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R. J. Motzer, A. Rakhit, M. Ginsberg, K. Rittweger, J. Vuky, R. Yu, S. Fettner, and L. Hooftman
Phase I Trial of 40-kd Branched Pegylated Interferon Alfa-2a for Patients With Advanced Renal Cell Carcinoma
J. Clin. Oncol., March 1, 2001; 19(5): 1312 - 1319.
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R. J. Motzer, B. A. Murphy, J. Bacik, L. H. Schwartz, D. M. Nanus, T. Mariani, P. Loehrer, G. Wilding, D. L. Fairclough, D. Cella, et al.
Phase III Trial of Interferon Alfa-2a With or Without 13-cis-Retinoic Acid for Patients With Advanced Renal Cell Carcinoma
J. Clin. Oncol., August 16, 2000; 18(16): 2972 - 2980.
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R. J. Motzer, M. Mazumdar, J. Bacik, P. Russo, W. J. Berg, and E. M. Metz
Effect of Cytokine Therapy on Survival for Patients With Advanced Renal Cell Carcinoma
J. Clin. Oncol., May 9, 2000; 18(9): 1928 - 1935.
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