e17536 Background: Sorafenib (SR) and sunitinib (SU) are FDA approved (12/05 and 1/06, respectively) tyrosine kinase inhibitors for patients (pts) with advanced renal cell carcinoma (RCC). Little is known of their cost impact. We conducted this study to quantify overall direct costs (inpatient, outpatient, pharmacy) for each treatment in privately insured pts (<65 y). Given differences between private and public insurer payment scales, pts ≥65 y were not included in this study but are the subject of a planned further analysis. Methods: A retrospective US claims-based study was conducted using data covering all US census regions for ≥18 million lives from MarketScan MedStat (1/02–12/07). Inclusion criteria were ≥2 RCC claims (ICD-9 189.0, 198.0), continuous health care coverage, >180 days of coverage before RCC diagnosis. SR and SU pts were identified based on oral therapy after initial RCC-related claim (intent-to-treat). Observation period was from first drug-dispensing date until ≤12 mo or first of therapy switch, nephrectomy, disenrollment, or study end (12/31/07). Univariate and multivariate Tobit analyses were conducted; control factors included age, sex, region, plan type, comorbidity, prior Tx/procedures, and time since RCC Dx. Results: Of 10,462 RCC pts identified, 144 and 220 received initial therapy with SR and SU, respectively. In the 180 days before RCC diagnosis, total direct medical costs, baseline demographics, and comorbidities were similar between groups. The univariate incremental total monthly medical cost for SU was $2,049 (P<.001) more than for SR, representing yearly costs for SU $24,588 more than for SR. Multivariate analyses for incremental total monthly costs for SU also remained significant at $1,399 (P<.001). Conclusions: Retrospective analysis of this US claims database for RCC pts <65 treated first with SR showed statistically significant lower total medical costs (particularly inpatient costs) than for pts treated first with SU. [Table: see text] [Table: see text]