777TiP - Second Interim Analysis of the Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib (GIDEON) Study According to Disease Stage

Abstract

ABSTRACT Background GIDEON (NCT00812175) is an ongoing, global, prospective, non-interventional study of patients with unresectable hepatocellular carcinoma (HCC) receiving sorafenib (Nexavar®) in real-life practice. The aim is to evaluate sorafenib safety and efficacy in diverse settings and patient groups. The second interim analysis was triggered when ∼1500 patients had been treated for ≥ 4 months. We describe sorafenib use in Europe according to disease stage. Methods Patient/disease characteristics (including Barcelona Clinic Liver Cancer [BCLC], tumour node metastases [TNM], Cancer for the Liver Italian Programme [CLIP]) and treatment history were recorded at enrolment; sorafenib dose, concomitant medications, performance status, liver function, adverse events (AEs) and efficacy are recorded at follow-up visits. Results Of 1571 patients in the safety population, 588 are in Europe (see table). The majority of patients were BCLC-C (52.9%), TNM III (40.3%) or CLIP 1/2 (26.0%/25.9%), although sorafenib was also used in patients with early, intermediate and end-stage disease. Generally, AEs and serious AEs (SAEs) increased with advancing disease (AEs: 66.0%, 87.4%, 85.5%, 89.7%; SAEs: 22.6%, 37.8%, 38.3%, 58.6%; for BCLC-A, B, C and D; respectively), whereas sorafenib-related AEs and SAEs were comparable across BCLC groups (AEs: 60.4%, 74.1%, 68.5%, 41.4%; SAEs: 7.5%, 15.4%, 10.3%, 10.3%; for BCLC-A, B, C and D; respectively). Evaluation will continue with more mature data. Medical oncologist (n = 189) Hepatologist/ GI specialist (n = 332) EU total (n = 588) BCLC stage at study entry, % of n A 6.9 8.7 9.0 B 19.6 27.7 24.3 C 59.3 50.6 52.9 D 3.2 5.4 4.9 NE/missing 11.1 7.5 8.8 TNM stage at study entry, % of n I 3.2 10.5 8.8 II 8.5 12.3 10.2 III 39.2 41.9 40.3 IV 40.2 19.9 26.9 NE/missing 9.0 15.4 13.8 Child-Pugh score at start of sorafenib therapy, % of n A 68.3 64.8 66.3 B 13.8 26.8 21.6 C 1.1 1.8 1.5 NE/missing 16.9 6.6 10.5 CLIP score at start of sorafenib therapy, % of n 0 14.8 8.4 11.9 1 24.3 26.5 26.0 2 24.3 26.5 25.9 3 5.8 15.7 11.4 4–6 4.2 11.4 8.7 NE/missing 26.5 11.4 16.2 NE, not evaluable Conclusions These data reflect real-world sorafenib given to a broad range of patients, indicating a similar safety profile across the different disease stages. Evaluation is ongoing, with more mature data expected from the final analysis. Disclosure B. Daniele: Dr B. Daniele has participated in advisory boards and received lecture fees from Bayer. J. Turnes: Dr J Turnes has participated in advisory boards for Roche Pharma. C. Papandreou: Prof. C Papandreou has participated in advisory boards for Bayer, Sanofi Aventis, Novartis, Bristol Meyers Squibb and Janssen. P. Stal: Prof. Stal has advised and received a grant from Bayer. A. Croitoru: Dr A Croitoru has consulted for and received an investigator fee from Bayer. P: Mathurin: Dr. P . Mathurin was paid speaking at symposia for Roche, Schering-Plough, Gilead Sciences, Bristol-Myers Squibb, Janssen-Cilag and Bayer Healthcare pharmaceutical companies. He is an investigator for Roche, Schering-Plough, Bristol-Myers Squibb, Gilead Sciences, Vertex pharmaceuticals Janssen-Cilag, Boeringher, Novartis and Bayer Healthcare companies. He is a member of the French boards of experts in Hepatology for Roche Schering-Plough, Gilead Sciences, Bayer Healthcare and Bristol-Myers Squibb pharmaceutical companies. He is consulting for the Gilead Sciences, Bristol-Myers Squibb, Bayer Healthcare and Vertex pharmaceutical Companies. All other authors have declared no conflicts of interest.