Randomized Controlled Trial Evaluates Dexamethasone for Preventing TACE Side Effects
In patients with hepatocellular carcinoma (HCC), a regimen of prophylactic dexamethasone prior to transcatheter arterial chemoembolization (TACE) is more effective at preventing fever, anorexia, and nausea/vomiting than a control regimen.
“To our knowledge, this is the first well-designed randomized, double-blind, placebo-controlled trial that modeled randomized controlled trials of prophylactic treatments for side effect of chemo agents,” the researchers wrote.
For the trial, 120 Child-Pugh class A/B patients with HCC and no macrovascular invasion/extrahepatic metastases were randomly assigned to receive dexamethasone or a control regimen before TACE. Those in the dexamethasone group received 20 mg of intravenous dexamethasone and 3 mg of granisetron on day 1, followed by 8 mg of dexamethasone on days 2 and 3. Patients in the control group received intravenous saline placebo and 3 mg of granisetron on day 1, followed by intravenous placebo on days 2 and 3. The trial took place between October 2010 and June 2013.
The investigators evaluated patients’ complete response after the prophylactic regimen and TACE. Complete response was defined as the absence of grade ≥1 fever, anorexia, or nausea/vomiting according to the Common Terminology Criteria for Adverse Events, as well as no use of rescue therapy for 120 hours after TACE.
Results indicated that 47.5% of patients in the dexamethasone regimen group had a complete response [95% CI: 34.3-60.9%]), compared with 10.2% of those in the control group (95% CI: 3.8-20.8%). Patients in the control group experienced more overall incidences of fever, anorexia, and nausea/vomiting than patients in the dexamethasone group.
Most patients tolerated the dexamethasone group, including those with hepatitis B infection and those with well-controlled diabetes.
“This study demonstrated the utility and tolerability of dexamethasone for prevention of postembolization syndrome with respect to TACE, based on the well-designed randomized, placebo-controlled trial. Our results provide a standard for further development of prophylactic regimens to prevent TACE-induced postembolization syndrome,” the researchers concluded.
Ogasawara S, Chiba T, Ooka Y, et al. A randomized placebo-controlled trial of prophylactic dexamethasone for transcatheter arterial chemoembolization. Hepatology. 2017 Jul 26; doi: 10.1002/hep.29403.