Originally published as JCO Early Release 10.1200/JCO.2008.21.4809 on October 13 2009

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Prognostic Factors for Overall Survival in Patients With Metastatic Renal Cell Carcinoma Treated With Vascular Endothelial Growth Factor–Targeted Agents: Results From a Large, Multicenter Study

From the Tom Baker Cancer Center, Calgary; Cross Cancer Institute, Edmonton, Alberta; Princess Margaret Hospital, Toronto, Ontario; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Harvard School of Public Health; Dana-Farber/Harvard Cancer Center Renal Cancer Program, Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Boston, MA; Medical University of South Carolina, Charleston, SC; and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.

Corresponding author: Daniel Y.C. Heng, MD, MPH, FRCPC, Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, 1331 29th St NW, Calgary, Alberta, Canada T2N 4N2; e-mail: daniel.heng{at}cancerboard.ab.ca.

Purpose There are no robust data on prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with vascular endothelial growth factor (VEGF) –targeted therapy.

Methods Baseline characteristics and outcomes on 645 patients with anti-VEGF therapy–naïve metastatic RCC were collected from three US and four Canadian cancer centers. Cox proportional hazards regression, followed by bootstrap validation, was used to identify independent prognostic factors for OS.

Results The median OS for the whole cohort was 22 months (95% CI, 20.2 to 26.5 months), and the median follow-up was 24.5 months. Overall, 396, 200, and 49 patients were treated with sunitinib, sorafenib, and bevacizumab, respectively. Four of the five adverse prognostic factors according to the Memorial Sloan-Kettering Cancer Center (MSKCC) were independent predictors of short survival: hemoglobin less than the lower limit of normal (P < .0001), corrected calcium greater than the upper limit of normal (ULN; P = .0006), Karnofsky performance status less than 80% (P < .0001), and time from diagnosis to treatment of less than 1 year (P = .01). In addition, neutrophils greater than the ULN (P < .0001) and platelets greater than the ULN (P = .01) were independent adverse prognostic factors. Patients were segregated into three risk categories: the favorable-risk group (no prognostic factors; n = 133), in which median OS (mOS) was not reached and 2-year OS (2y OS) was 75%; the intermediate-risk group (one or two prognostic factors; n = 301), in which mOS was 27 months and 2y OS was 53%; and the poor-risk group (three to six prognostic factors; n = 152), in which mOS was 8.8 months and 2y OS was 7% (log-rank P < .0001). The C-index was 0.73.

Conclusion This model validates components of the MSKCC model with the addition of platelet and neutrophil counts and can be incorporated into patient care and into clinical trials that use VEGF-targeted agents.

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

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