Dexamethasone for the prevention of transcatheter arterial chemoembolization-induced fever, nausea, vomiting, and anorexia in patients with hepatocellular carcinoma: A randomized, double-blind, placebo-controlled trial.

4071 Background: Fever, nausea, vomiting, and anorexia are the most frequent adverse events of transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). In this study the efficacy of dexamethasone in preventing these events was evaluated. Methods: Patients with HCC who had a Child–Pugh score of A or B and who lacked macrovascular invasion/extrahepatic metastasis were included in this study. Patients were randomly assigned to either a dexamethasone regimen [day 1, intravenous dexamethasone (20 mg) and granisetron (3 mg) before TACE; day 2 and 3, intravenous dexamethasone (8 mg)] or a control regimen [day 1, intravenous placebo (saline) and granisetron (3 mg); day 2 and 3, intravenous placebo]. The primary endpoint was a complete response (CR), which was defined as no grade 1 or higher fever, nausea, vomiting, or anorexia, according to CTCAE (version 4.0), and no use of rescue therapy for 120 h after TACE. Results: From October 2010 to June 2013, 120 patients were randomly assigned. One patient randomly assigned to the dexamethasone regimen did not receive TACE and was therefore excluded from analysis. Thus, 59 patients were randomly assigned to the dexamethasone regimen and 60 to the control regimen and underwent intention-to-treat analysis. The overall CR rate was greater with the dexamethasone regimen than with the control regimen (47.5% vs. 10.2%; P < 0.001). The overall incidence of fever, nausea and vomiting, and anorexia within 120 h following TACE were 28.8%, 27.1%, and 33.9% in the dexamethasone regimen and 72.9%, 47.5%, and 78.0% in the control regimen, respectively. The rate of fever, nausea and vomiting, and anorexia were significantly higher in patients receiving the control regimen than those receiving the dexamethasone regimen (fever: P < 0.001, nausea and vomiting: P = 0.022, and anorexia: P < 0.001). Both treatment regimens were generally well tolerated. Conclusions: The dexamethasone regimen was more effective than the control regimen for the prevention of TACE-induced fever, nausea, vomiting, and anorexia in patients with HCC. Clinical trial information: UMIN000004317.