Real-world experience with sunitinib treatment in patients with metastatic renal cell carcinoma: Clinical outcome according to risk score.

Abstract

606 Background: ADONIS, an ongoing, observational study in 9 EU countries, evaluates treatment patterns/outcomes in patients (pts) with metastatic renal cell carcinoma treated with 1st-line (1L) sunitinib (SU) and/or 2nd-line (2L) axitinib (AX) post SU. Analysis of the data is planned in 4 parts, to occur stepwise as data matures; evaluation of SU efficacy in intermediate (INT) risk pts is presented here. Future analyses include sequencing data, SU followed by AX and other treatments (cabozantinib, nivolumab and others); SU and AX therapy management strategies, and quality of life. Methods: Pts enroll at start of 1L SU or 2L AX post SU. Data cutoff: May 31, 2018. Analysis focused on 1L SU. Results: 467 pts, median age 64 y (range 31–90), 77.7% were male, with ECOG PS < 2 = 90.2% and ECOG PS ≥ 2 = 9.8% at SU initiation. Overall median progression-free survival (mPFS) was 10.4 mo (95% CI 9.3–12.5), and median overall survival (mOS) 34.0 mo (95% CI 28.3–46.6). Data on individual risk factors (RF) were available for 120 pts, allowing analysis by INT 1RF and INT 2RF groups for this subset. Clinical trial information: NCT02184416. Conclusions: For pts overall and by risk group stratification, survival estimates were aligned with improvements in clinical practice over the past decade. In pts with INT risk with 1RF, OS was very similar to pts with good risk. However further exploration is needed to confirm these observations.[Table: see text]