A randomized placebo‐controlled trial of prophylactic dexamethasone for transcatheter arterial chemoembolization

Abstract

The dexamethasone regimen was more effective than the control regimen at preventing TACE-induced fever, anorexia, and nausea/vomiting in patients with HCC. (Hepatology 2017).

Patient Selection for Transarterial Chemoembolization in Hepatocellular Carcinoma: Importance of Benefit/Risk Assessment

“…The most common adverse events were related to the postembolization syndrome, and included liver enzyme abnormalities (18.1%), fever (17.2%), abdominal pain (11.0%), vomiting (6.0%), and nausea (1.7%). Recently, the incidence of postembolization syndrome was shown to be reduced by a short course of steroids [39], but external validation and effects on oncological outcomes in larger populations with longer follow-up are required before such prophylaxis can be fully endorsed [40]. Hematological/bone marrow toxicity occurred in 13.5% of patients.…”

A new horizon in the prevention of the postembolization syndrome after transcatheter arterial chemoembolization for hepatocellular carcinoma

“…Regarding the other specific adverse events that seem to be associated with dexamethasone, ascites, pleural effusion, and hypertension showed a trend (though not statistically significant) toward being more frequent in the dexamethasone group than in the placebo group, which is as expected based on the effects of steroids. Furthermore, one patient had a hepatic infection grade of ≥3 and another patient had a heart failure grade of ≥3 in the dexamethasone group, although there were no significant differences in grade ≥3 adverse events between the two treatment groups . However, these trends must be verified in larger studies and, most importantly, should be considered with caution from now on if multiple courses of TACE are needed, given that the severity of such events may become more important.…”

“…The prophylactic use of corticosteroids and 5‐HT3 receptor antagonists had been already demonstrated as efficacious in reducing nausea and vomiting in various chemotherapeutic regimens for other tumors and are therefore recommended by the American Society of Clinical Oncology in various situations. However, a well‐designed randomized, double‐blind, placebo‐controlled trial in HCC was still missing until the study published by Ogasawara et al in this issue of H epatology . In this multicenter Japanese study, dexamethasone treatment (20 mg on day 1, in addition to granisetron, in a single session immediately before TACE followed by 8 mg in a single morning session on days 2 and 3) was compared with a control regimen (placebo and granisetron on day 0, followed by placebo on days 2 and 3) in 120 patients undergoing superselective TACE for HCC (using lipiodol plus a chemotherapeutic agent, followed by gelatine sponge particles).…”

“…However, a well-designed randomized, double-blind, placebocontrolled trial in HCC was still missing until the study published by Ogasawara et al in this issue of HEPATOLOGY. (9) In this multicenter Japanese study, dexamethasone treatment (20 mg on day 1, in addition to granisetron, in a single session immediately before TACE followed by 8 mg in a single morning session on days 2 and 3) was compared with a control regimen (placebo and granisetron on day 0, followed by placebo on days 2 and 3) in 120 patients undergoing superselective TACE for HCC (using lipiodol plus a chemotherapeutic agent, followed by gelatine sponge particles). The primary endpoint was the cumulative absence of fever, anorexia, and nausea/vomiting and no rescue therapy within 5 days after the procedure, defined as complete response.…”

The Use of Steroid for Transcatheter Arterial Chemoembolization: To Relieve Symptoms or to Mask Adverse Events?

“…I read with interest the article by Ogasawara et al regarding the use of dexamethasone to prevent the occurrence of fever, anorexia, abdominal pain, and nausea/vomiting after transcatheter arterial chemoembolization (TACE), so‐called postembolization syndrome (PES). ( ) PES has affected a number of patients with advanced hepatocellular carcinoma. Drugs that could prevent PES would be welcomed by both clinicians and patients.…”