Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study

Abstract

BackgroundThis study aimed to investigate the safety of sorafenib for the treatment of unresectable hepatocellular carcinoma in Chinese patients.MethodsA subgroup of 345 Chinese patients from the international database of the Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study was included in this analysis. Safety assessment measures were adverse events (AEs) and serious adverse events (SAEs) graded using the National Cancer Institute Common Terminology Criteria version 3.0.ResultsOf 331 evaluable patients, 98% started sorafenib at 800 mg/day. The median treatment duration was 22 weeks (range, 0.1–116 weeks), and median overall survival (OS) was 322 days (10.7 months). Approximately 50% of patients had at least one adverse event, and 6% had grade 3–4 adverse events. Drug-related adverse events were experienced by 29% of patients, and 3.6% had grade 3–4 drug-related adverse events. Overall, 23% of patients (n = 77) experienced serious adverse events, among which only 1 event was drug-related (0.3%). No differences in overall adverse events, serious adverse events, and deaths were observed between Child-Pugh A and Child-Pugh B patients. The most frequent drug-related adverse events were dermatological/skin (24%), hand-foot skin reaction (20%), gastrointestinal (11%), and diarrhea (11%). The majority of adverse events occurred within 30 days of beginning sorafenib.ConclusionSorafenib has satisfactory efficacy and safety in Chinese Child-Pugh A and B patients with unresectable HCC using the recommended dosage of 800 mg/day, and the safety of sorafenib is not affected by liver function. Prophylaxis for gastrointestinal adverse events may help to decrease dose interruptions or discontinuation.Trial registrationClinicalTrials.gov; Identifier: NCT00812175. Date of registration: December 19, 2008.Electronic supplementary materialThe online version of this article (10.1186/s12885-018-4144-9) contains supplementary material, which is available to authorized users.

Transarterial Chemoembolization (TACE) Combined with Sorafenib versus TACE Alone for Unresectable Hepatocellular Carcinoma: A Propensity Score Matching Study

“…Evidence from recently studies have suggested that common AEs are associated with the use of sorafenib, the most common being hand-foot skin reactions, diarrhea, alopecia, and fatigue 39, 40. Similar safety outcomes were found in the current study, which revealed hand-foot skin reaction and diarrhea to be the most common drug-emergent AEs, followed by alopecia and fatigue.…”

Efficacy and Safety of TACE Combined With Sorafenib Plus Immune Checkpoint Inhibitors for the Treatment of Intermediate and Advanced TACE-Refractory Hepatocellular Carcinoma: A Retrospective Study

“…The AEs in this study were mild to moderate and could easily be controlled. The incidences of postembolization syndrome, such as nausea, vomiting, fever, and abdominal pain, and sorafenib-related AEs, such as hand-foot syndrome, hypertension, diarrhea, and alopecia, were similar to those in previous studies of patients treated with TACE combined with sorafenib and TACE or sorafenib alone (Lencioni et al, 2016 ; Meyer et al, 2017 ; Ye et al, 2018 ; Kudo et al, 2020 ). The incidence of dose reductions or interruptions between the two groups was not significantly different.…”

Clinical Significance of Adverse Events for Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study

“…It has previously been reported that albumin-bilirubin (ALBI) grade [ 10 , 11 ], neutrophil-to-lymphocyte ratio (NLR) [ 12 ], controlling nutritional status (CONUT) [ 13 ], and relative dose intensity [ 14 ] were predictive factors for OS or therapeutic effect in LEN treatment for HCC. Despite the reported efficacy of MTAs, including LEN, the high rate of adverse events (AEs) currently limits their application in a clinical setting [ 15 ]. LEN targets vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3) and fibroblast growth factor (FGF) receptors 1-4 (FGFR1-4) [ 16 , 17 ], which strongly inhibit tumor angiogenesis.…”