GIDEON (Global Investigation of therapeutic DE cisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis

Abstract

BackgroundGIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials.MethodsPatients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ∼1500 treated patients were followed up for ≥ 4 months.ResultsOf the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population.ConclusionsConsistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.

Refining Sorafenib Therapy: Lessons from Clinical Practice

“…Data from GIDEON showed that patients on the higher, approved, 800-mg starting dose had better efficacy outcomes than patients starting treatment on a dose of 400 mg/day [11,22]. In this realworld study, 74% of patients started sorafenib treatment at the approved dose.…”

“…In these patients, median OS was extended by over 2 months and median time to progression (TTP) was extended by approximately 1 month compared with the lower-starting-dose group (9.3 vs 7.1 months and 4.5 vs 3.6 months, respectively) [22]. In terms of safety, the findings for the approvedand low-dose groups were similar, with approximately 30% of patients receiving sorafenib dose modifications irrespective of the starting dose (35% with 800 mg/day and 32% with 400 mg/ day) and no significant differences in the types or incidences of AEs between the two groups [11,22]. A recent subanalysis of European patients included in the GIDEON noninterventional study has closely echoed these findings [23].…”

“…Since approval was granted to sorafenib, physicians have accrued a wealth of experience with the fine-tuning of sorafenib in their daily clinical practice, and several 'real-world' studies have continued to investigate the safety and efficacy of sorafenib. Among them is a multinational postmarketing study, GIDEON, and the Italian field-practice study by the Sorafenib Italian Assessment (SOFIA) study group [7][8][9][10][11], as well as a number of other studies in Europe and North America [12][13][14][15] . These real-world experiences have allowed us to assess sorafenib in patients who are not selected by strict clinical trial criteria but by physician judgment, including patients with comorbidities and those receiving concomitant medication.…”

Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data

“…(5) The most popular TACE technique has been the administration of an anticancer agent-in-oil emulsion followed by embolic agents. (6) The key component of this procedure is lipiodol (Guerbet, Paris, France), which is used both as a vehicle to carry and localize the chemotherapeutic agent inside the tumor and as a microembolic agent for tiny tumor vessels.…”

Survival and cost‐effectiveness of sorafenib therapy in advanced hepatocellular carcinoma: An analysis of the SEER–Medicare database

“…(3) The Global Investigation of Therapeutic Decision in Hepatocellular Carcinoma and of Its Treatment with Sorafenib (GIDEON) data suggest sorafenib is well tolerated by patients with Childs-Pugh class B cirrhosis and advanced HCC with a median survival of 5.2 months, but this post-marketing study did not have a comparator arm so analyses of survival benefit have relied on comparisons to historical controls. (4,5) Further, we lack an understanding of how health system characteristics (e.g., being seen at a tertiary care referral center, impact treatment effectiveness and survival). The population of patients with HCC is shifting to a more elderly demographic, largely due to an aging population with chronic hepatitis C virus infection; thus, the impact of age and accumulated comorbidities is becoming increasingly relevant when making HCC treatment decisions.…”