Epidemiological trends in metastatic renal cell carcinoma in the era of targeted therapies: An analysis of the SEER registry.
516 Background: Clear cell RCC (ccRCC) accounts for 70-75% of all kidney and renal pelvis cancers with approximately 16% of patients presenting with distant (metastatic) disease. Five year overall survival (OS) remains dismal at 11.2% for patients with distant disease. Several tyrosine kinase inhibitors (TKI) were approved by US Food and Drug Administration for use in metastatic RCC between 2005 and 2012. While these therapies have been shown to improve outcomes in metastatic ccRCC, the long term impact remains unknown. Methods: The Surveillance, Epidemiology and End-Results (SEER) database was queried for patients aged 18 years and older diagnosed with distant stage (metastatic) ccRCC between 2001 and 2012 in the nine core SEER registries. Analyses were restricted to histologically confirmed cases. Study period was divided into 3-year intervals: 2001-03 (pre-TKI era); 2004-06 (TKI trials era); 2007-09 (early TKI era); and 2010-12 (sequential TKI era). Patients were stratified by age at diagnosis: 18-60 years, 60-69 years, and 70+ years. One, two, and three year, and median cause-specific survival were calculated by Kaplan-Meier method. Differences in cause-specific survival by time period were assessed with the Log-Rank test. Results: A total of 3,747 eligible patients were included in the analysis. For all ages combined, cause-specific survival at three years post-diagnosis was 18.8% for those diagnosed during the period 2001-03 (median 8 months), 22.7% in 2004-06 (median 10 months), 23.2% in 2007-09 (median 9 months), and 28.9% in 2010-12 (median 11.0 months) (p= 0.0004). No statistically significant improvement in survival was observed in patients aged 70 years and above (p= 0.1302). Conclusions: Our analysis quantifies the improvement in survival outcomes in metastatic ccRCC that correlate with TKI use in this setting. While there is evidence that all age groups may have benefitted from these therapies, the impact is least pronounced in patients aged 70 years and above. A SEER-Medicare analysis is planned to evaluate disparities in TKI use in this age group.