RECORD-4 multicenter phase II trial of second-line everolimus (EVE) in patients (pts) with metastatic renal cell carcinoma (mRCC): Anti-VEGF cohort subanalysis.

Abstract

611 Background: RECORD-4 assessed EVE in pts with mRCC who progressed after only 1 prior therapy and enrolled pts into 3 cohorts based on first-line sunitinib (cohort 1), other anti-VEGF agents (cohort 2) or cytokines (cohort 3) (J Clin Oncol2015;abstr 4518). Median PFS in cohort 2 was 7.8 mo (95% CI, 5.7-11). This RECORD-4 subanalysis assessed EVE outcomes after individual first-line anti-VEGF agents in cohort 2. Methods: Pts received EVE 10 mg/d until progression of disease (RECIST, v1.0) or intolerance. Primary end point was PFS per investigator review. Data cutoff was Sept 1, 2014. In this analysis, efficacy and safety were analyzed for pts in cohort 2 (n=62) who received sorafenib (Sor, n=23), bevacizumab (Bev, n=16), pazopanib (Paz, n=13), tivozanib (Tiv, n=5), or axitinib (Ax, n=3); missing information for 2 pts. Results: In groups Sor/Bev/Paz/Tiv/Ax, respectively, 96/81/100/80/33% of pts had good/intermediate MSKCC prognosis, 30/94/54/100/100% were white, 70/0/38/0/0% were Asian, and 83/75/77/100/67% were <65 years of age. Median duration of exposure in groups Sor/Bev/Paz/Tiv/Ax, respectively, was 5.5/6.7/6.2/8.1/11 mo. Median PFS (95% CI) was 5.7 (3.6-11.3) mo in group Sor, 9.2 (2.2-NE) mo in group Bev, and 9.2 (1.9-18.0) mo in group Paz. Overall rate of grade 3/4 adverse events (AEs), rates of discontinuation due to AEs, and rates of dose adjustments due to AEs are presented in the table. Conclusions: Results of this RECORD-4 subanalysis demonstrated a favorable benefit-risk profile of second-line EVE in pts whose disease progressed during or after first-line anti-VEGF therapies. Results should be interpreted with caution due to small patient numbers. Clinical trial information: NCT01491672. [Table: see text]