Introduction

Adjuvant sunitinib (SU; 50 mg daily, schedule 4/2) significantly improved disease-free survival (DFS) vs. placebo (PBO) in patients with locoregional renal cell carcinoma (RCC) at high risk of tumor recurrence after nephrectomy (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.59-0.98; P=0.03, median: 6.8 vs. 5.6 years, respectively). We report new details on study population, treatment, pattern of recurrence, and the relationship between baseline factors and DFS.

Methods

Treatment exposure was assessed by treatment group during cycles. Disease recurrence was based on centrally confirmed imaging and/or histological findings. Subgroup analyses of DFS were conducted to explore the potential influence of baseline factors including, modified UISS criteria (T3 low, T3 high, T4-Any T, N+, and T3 high+T4-Any T, N+), age (<45, 45-65, ≥65 years), gender (male, female), Eastern Cooperative Oncology Group performance status (ECOG PS; 0, ≥1), weight (18.5≤BMI<25, 25≤BMI<30, BMI≥25, BMI≥30), and neutrophil-to-lymphocyte ratio (≤3, >3). Other baseline risk factors explored in the subgroup analyses included UISS criteria and Fuhrman grade.

Results

Overall, 615 patients were enrolled from 97 sites. >70% of patients received SU treatment for ≥6 cycles (~8 months) and 56% completed the full 1-year treatment. A total of 97 patients (31.4%) in the SU arm and 122 (39.9%) in the PBO arm developed metastatic disease recurrence. Most common sites of distant recurrence (SU:PBO) were lung (13%:16%), lymph node (7%:9%), and liver (4%:5%). The benefit of adjuvant sunitinib over placebo (HR<1) was observed across several subgroups of patients (Table 1). Additional subgroups analyses, including detailed Fuhrman grades and UISS criteria, will be presented._x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_

Conclusions

The subgroup analyses showed improved DFS with adjuvant SU vs. placebo in several subgroups. These results support the primary analysis showing benefit for adjuvant SU in patients with RCC at high risk for recurrent disease after nephrectomy.

Funding

The study was funded by Pfizer Inc.