Large open-label, non-comparative, clinical experience trial of the multi-targeted kinase inhibitor sorafenib in European patients with advanced RCC

Abstract

16021 Background: A randomized, controlled phase III trial showed sorafenib 400 mg BID doubled PFS and produced a 39% improvement trend in OS vs PBO in previously treated pts with RCC. Objectives of this trial were to collect safety and efficacy data from a large and broad study population reflecting clinical practice Methods: This nonrandomized, open-label study included pts with ECOG PS 0–2 and life expectancy >2 mo. Pts had to be unsuitable for or have failed prior cytokine therapy. Controlled, asymptomatic brain metastases were allowed. Pts received sorafenib 400 mg BID until progression, intolerable toxicity, or withdrawal. Study assessments were conducted at baseline and q mo. Tumor assessment and radiologic evaluation were conducted ≤28d prior to start of sorafenib therapy, then per local standard of care, but at least q3 mo Results: 1,155 pts were recruited in 11 European countries. 75% of pts were male with median age 62 yrs. Baseline ECOG PS was 0/1/2 in 40/45/15% of pts. 73% of pts had lesions in the lungs, 41% in lymph nodes, 36% in bone, 28% in the liver and 23% in the kidneys. Primary tumors were not resected in 11% of pts. 28% of pts enrolled had no prior systemic therapy, as they were unsuitable for cytokine treatment. Most frequent Grade ≥3 drug-related AEs were hand-foot-skin reaction 12%, fatigue 8%, diarrhea 5%, rash/desquamation 5% and hypertension 4%. Rates of Grade ≥3 drug-related AEs were similar across evaluated subpopulations. Median PFS was 6.8 mo (95% CI, 6.2–7.5 mo), and the median duration of treatment 6.9 mo (95% CI, 6.2–7.5 mo). Presentation will include analyses of the complete population and long-term follow up Conclusions: EU-ARCCS confirmed safety findings of the TARGET study in a clinical practice setting and in clinically relevant pt subsets. The efficacy of sorafenib in this clinical study appears similar to that reported in randomized controlled clinical trials Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer Bayer Bayer Bayer Bayer