Risk Factor Migration And Survival: Analysis From International Dataset Of 3,748 Metastatic Renal Cell Carcinoma (Mrcc) Patients Treated On Clinical Trials

4554 Background: Temporal shifts in the distribution of risk factors recorded at diagnosis can have a direct impact on clinical trial design and interpretation of outcome. Shifts may be a result of earlier more precise detection and diagnosis of metastatic disease. This analysis aims to investigate shifts in the frequency of known risk factors for mRCC patients in a multicenter, international experience of patient data collected to examine prognostic factors (Clin Cancer Res. 10[18 Pt 2]). Methods: An international database of 3748 patients with no prior systemic therapy and who were treated from 1975 to 2002 was constructed by pooling patient data from clinical trials conducted in the United States and Europe who met entry criteria. Systemic therapy included cytokines, chemotherapy, or various investigational agents. Proportions of known risk factors (low performance status, low HGB, high LDH, high corrected calcium, greater than 1 site of metastasis at diagnosis, nephrectomy, high neutrophils) were examined over six cohorts (1975 to 1980, 1981 to 1985, 1986 to 1990, 1991 to 1995, 1996 to 2000, 2001 to 2002). Overall survival for each cohort was examined using the Kaplan-Meier method. Results: Median overall survival increased with recently treated cohorts (Table). An increasing proportion of patients had prior nephrectomy (p=.0005). The proportions of patients with low performance status, high LDH, high adjusted calcium and high neutrophils have decreased over study year cohorts (all p