Abstract
4631 Background: The impact of OM on survival in patients with RCC is controversial. In several recent database studies OM have been reported to have a negative effect on survival (Negrier, Ann Oncol. 2002; 13:1460, Atzpoodien, B J Cancer. 2003; 88:348), while in others it has been reported to have no effect (Motzer, J Clin Oncol. 2002; 20:289). Methods: We evaluated a database comprised of 309 previously untreated metastatic RCC patients entered into IRB approved clinical trials at our institution between 1987 and 2002. Univariable and multivariable analyses were performed to evaluate the association between OM and survival. Results: 95 patients (31%) had OM at the time of entry on study. Univariate analysis suggested a negative impact of OM on survival; median survival was 12.2 versus 16.3 months with OM present and absent, respectively (p=0.09). A multivariable analysis was performed to analyze the impact of OM while considering other important prognostic factors. This analysis adjusted for the number of poor risk factors present (Motzer, J Clin Oncol. 2002; 20:289), the number of metastatic sites present (Abou Jawde, ASCO Proceedings. 2003; #1545), and histology (clear cell versus non-clear cell). Motzer's poor risk factors include Karnofsky performance status (< 80%), hemoglobin (< 13.5 g/dL for males and < 12.0 g/dL for females), LDH (> 220 U/L), corrected calcium (> 10 mg/dL), and time from tumor diagnosis to metastases (< 1 year). In this analysis the number of poor risk factors present, the number of metastatic sites present, and histology were found to be independent predictors of survival (p < 0.001, p=0.002, and p < 0.001, respectively). Correcting for these factors the impact of OM was not statistically significant (p=0.33). Conclusions: Adjusting for other important predictors, the presence of OM does not have an impact on survival in previously untreated RCC patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene; Chiron
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