First interim results of the global investigation of therapeutic decisions in hepatocellular carcinoma (HCC) and of its treatment with sorafenib (GIDEON) study: Use of sorafenib (Sor) by oncologists and nononcologists in the management of HCC.

Abstract

157 Background: GIDEON is an ongoing, global, prospective, non-interventional registry study of patients (pts) with unresectable HCC (uHCC) receiving Sor under real-life practice settings. From January 2009 to September 2010, over 2,200 pts have been enrolled from 32 countries. Per protocol, the first planned interim analysis was triggered when 500 enrolled pts were followed for at least 4 mos; the primary safety and efficacy results were reported in October 2010. A preplanned subset analysis of treatment patterns across MD specialities is reported here. Methods: Demographics, medical, disease and treatment history are recorded at enrolment; Sor dose, concomitant treatments, performance status, liver function are noted at follow-up. Standard efficacy measures and adverse events (AEs) are captured. Preplanned subanalysis by MD specialty was conducted. Results: Of the 141 treating MDs, 69 (49%) were hepatologists/gastroenterologists (Hep/GIs), 55 (39%) were medical oncologists (Oncs) and 17 (12%) were other specialties. Descriptive statistics of differences in pts' HCC stage, Sor treatment and AEs by the main specialties are shown for the 479 pts evaluable for safety (Table). Conclusions: Interim data from the GIDEON study suggests differential use of Sor by MD specialties. It appears that Oncs tend to treat with lower doses of Sor and for a somewhat shorter duration than Hep/GIs. If these data persist, it will be important to explore the reasons for these differences in Sor usage between Oncs and Hep/GIs and potential impact on patient outcomes. [Table: see text] No significant financial relationships to disclose.