First interim analysis of the GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) non-interventional study

Abstract

The GIDEON study is generating a large, robust database from a broad population of patients with uHCC. First interim analyses have shown global and regional differences in patient characteristics, disease aetiology and practice patterns. Subsequent planned analyses will allow further evaluation of early trends.

Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma

“…Recently, the GIDEON study, a global, non-interventional study, was conducted to evaluate the safety of sorafenib for HCC treatment under real-life practice conditions, particularly in Child-Pugh B patients. A shorter median OS was also observed in this group (4.8 vs. 10.3 months in Chilh-Pugh B vs. A patients, respectively); however, the safety profile favored the use of this agent in Child-Pugh B patients (13).…”

Comparison of standard-dose and half-dose sorafenib therapy on clinical outcome in patients with unresectable hepatocellular carcinoma in field practice: A propensity score matching analysis

“…There have been few studies comparing the clinical outcome and safety between different initial doses of sorafenib administered to HCC patients (10,13). HCC patients enrolled in RCTs do not necessarily represent the field practice owing to the absence of potential confounding factors such as comorbid diseases.…”

“…Our results suggest that initial half-dose sorafenib therapy for HCC can be a treatment option for some patients. While the interim analysis in the GIdEON study demonstrated a trend toward more evident clinical benefits for initial standard-dose sorafenib as compared with the initial half-dose sorafenib and patients who initiated standard-dose sorafenib tended to discontinue treatment later than patients who initiated half-dose sorafenib (12.3 vs. 9.7 weeks) and present a longer OS (9.3 vs. 7.1 months) and time to progression (4.5 vs. 3.6 months) (10,11,24). On the other hand, a recent comparative study reported from Japan showed that using propensity score matching, HCC patients treated with the initial half-dose sorafenib therapy (n=58) led to a comparable survival benefit compared with those treated with the standard-dose sorafenib therapy (n=58), which are in line with our present study results (13).…”

“…Although systemic chemotherapy such as doxorubicin was not demonstrated to be effective for the treatment of advanced HCC for several decades, two randomized phase III studies, namely the Sorafenib HCC Assessment Randomised Protocol (SHARP) study and the Asian Pacific study, showed that sorafenib therapy obtained survival benefit over placebo group for patients with unresectable HCC, and molecular targeted therapy with sorafenib is currently approved for use as first-line systemic chemotherapy in these patients (7,8). Furthermore, results with regard to the treatment efficacy and safety of sorafenib therapy for HCC in clinical practice were demonstrated by several field practice experiences, including the SOraFenib Italian Assessment (SOFIA) study and the Global Investigation of therapeutic dEcisions in HCC and Of its treatment with sorafeNib (GIdEON) study (9)(10)(11)(12). However, to the best of our knowledge, few studies compared the clinical outcomes and safety between different initial doses of sorafenib administered to HCC patients (10,13).…”

“…Furthermore, results with regard to the treatment efficacy and safety of sorafenib therapy for HCC in clinical practice were demonstrated by several field practice experiences, including the SOraFenib Italian Assessment (SOFIA) study and the Global Investigation of therapeutic dEcisions in HCC and Of its treatment with sorafeNib (GIdEON) study (9)(10)(11)(12). However, to the best of our knowledge, few studies compared the clinical outcomes and safety between different initial doses of sorafenib administered to HCC patients (10,13). In Japan, the investigations for optimal initial dose of sorafenib for unresectable HCC are still underway, although two pivotal studies recommended initial dose of sorafenib of 800 mg/day (7,8).…”