Improvement in overall survival of patients with advanced renal cell carcinoma: prognostic factor trend analysis from an international data set of clinical trials.

Overview

abstract

PURPOSE: We assessed temporal shifts in the frequency of risk factors for patients with metastatic renal cell carcinoma in a multicenter, international data set. MATERIALS AND METHODS: An international database of 3,748 patients treated with systemic therapy for metastatic renal cell carcinoma from 1975 to 2002 was constructed by pooling clinical trial data. Proportions of previously identified risk factors were examined during 6 specified time cohorts. Overall survival for each cohort was examined using the Kaplan-Meier method. Trends in overall survival from 1973 to 2008 were also examined in 25,271 patients from the SEER (Surveillance, Epidemiology and End Results) database. RESULTS: Median overall survival from start of treatment increased with each consecutive time cohort group. In the earliest cohort median overall survival was 0.5 years (95% CI 0.43-0.57), which increased to 1.63 years (95% CI 1.28-1.79) in 2001 to 2002. More patients had a history of nephrectomy in the most recent cohort (p = 0.001). The proportion of patients with low performance status, high lactate dehydrogenase and high adjusted calcium decreased by study entry year (each p <0.01). Analysis of overall survival from the SEER database showed similar improvement in the more contemporary diagnosis cohorts (p <0.001). Two-year overall survival in the earliest and latest diagnosis cohort was 14% (95% CI 13-14) and 22% (95% CI 21-24), respectively. CONCLUSIONS: Higher representation of favorable risk factors in recent years may have partly contributed to the improvement in overall survival observed in more recent metastatic renal cell carcinoma clinical trials. These shifts could affect the outcome interpretation.