In the Journals

Systematic review finds no new safety, efficacy concerns for lipiodol TACE in treating patients with HCC

A recent systematic review published in Hepatology found no new safety or efficacy concerns for lipiodol transarterial chemoembolization in treating patients with hepatocellular carcinoma.

“All [randomized controlled trials (RCTs)] comparing lipiodol [transarterial chemoembolization (TACE)] and best supportive care in the treatment of HCC were performed more than a decade ago,” Riccardo Lencioni, MD, interventional oncologist at the University of Miami Miller School of Medicine, and colleagues wrote. “Distinct technical advances in the performance of TACE and improved patient selection and management took place since the completion of these studies. Therefore, we performed a systematic literature review of the available evidence on the efficacy and safety of lipiodol TACE in treatment of HCC.”

Lipiodol TACE has been recommended as the standard for treating unresectable, large or multinodular non-invasive tumors isolated to the liver in patients with HCC classified in the intermediate stage, the researchers wrote. However, alternative options for treatment are currently undergoing clinical investigation. In addition, a recent meta-analysis questioned the evidence supporting TACE compared with no intervention.

To better understand the current efficacy and safety of this treatment, Lencioni and colleagues performed a systematic review of articles published between 1980 and 2013. For the efficacy review, they found 101 articles that included 10,108 patients treated with TACE. For the safety review, there were 217 articles including 15,351 patients.

For the efficacy analysis, the objective response rate was 52.5% (95% CI, 43.6-61.5) and the overall survival rate was 70.3% at 1 year, 51.8% at 2 years, 40.4% at 3 years and 32.4% at 5 years, which was consistent with the data reported in the previous meta-analysis. The median overall survival rate was 19.4 months (95% CI, 16.22-22.6), which was also consistent with previous data. For the safety analysis, liver enzyme abnormalities were the most commonly observed adverse effects, followed by symptoms associated with postembolization syndrome. The overall mortality rate was 0.6% and the most common cause of death was related to acute liver insufficiency.

No new safety concerns were identified; however, there was no standard definition of adverse events, the researchers wrote. In addition, the researchers were unable to update the results concerning survival benefit of TACE compared with no intervention.

“Based on the analysis of safety information available in literature, no new safety concerns were identified,” Lencioni and colleagues wrote. “The most common cause of death was liver insufficiency leading to hepatic failure, which suggests that accurate patient selection, based on careful assessment of baseline liver function parameters, may be a key factor to minimize the risk of treatment-related death and reduce liver-related adverse events.” – by Will Offit

Disclosure: Lencioni reports consulting for Guerbet, BTG and Bayer. Please see the full study for a list of all other researchers’ relevant financial disclosures.

A recent systematic review published in Hepatology found no new safety or efficacy concerns for lipiodol transarterial chemoembolization in treating patients with hepatocellular carcinoma.

“All [randomized controlled trials (RCTs)] comparing lipiodol [transarterial chemoembolization (TACE)] and best supportive care in the treatment of HCC were performed more than a decade ago,” Riccardo Lencioni, MD, interventional oncologist at the University of Miami Miller School of Medicine, and colleagues wrote. “Distinct technical advances in the performance of TACE and improved patient selection and management took place since the completion of these studies. Therefore, we performed a systematic literature review of the available evidence on the efficacy and safety of lipiodol TACE in treatment of HCC.”

Lipiodol TACE has been recommended as the standard for treating unresectable, large or multinodular non-invasive tumors isolated to the liver in patients with HCC classified in the intermediate stage, the researchers wrote. However, alternative options for treatment are currently undergoing clinical investigation. In addition, a recent meta-analysis questioned the evidence supporting TACE compared with no intervention.

To better understand the current efficacy and safety of this treatment, Lencioni and colleagues performed a systematic review of articles published between 1980 and 2013. For the efficacy review, they found 101 articles that included 10,108 patients treated with TACE. For the safety review, there were 217 articles including 15,351 patients.

For the efficacy analysis, the objective response rate was 52.5% (95% CI, 43.6-61.5) and the overall survival rate was 70.3% at 1 year, 51.8% at 2 years, 40.4% at 3 years and 32.4% at 5 years, which was consistent with the data reported in the previous meta-analysis. The median overall survival rate was 19.4 months (95% CI, 16.22-22.6), which was also consistent with previous data. For the safety analysis, liver enzyme abnormalities were the most commonly observed adverse effects, followed by symptoms associated with postembolization syndrome. The overall mortality rate was 0.6% and the most common cause of death was related to acute liver insufficiency.

No new safety concerns were identified; however, there was no standard definition of adverse events, the researchers wrote. In addition, the researchers were unable to update the results concerning survival benefit of TACE compared with no intervention.

“Based on the analysis of safety information available in literature, no new safety concerns were identified,” Lencioni and colleagues wrote. “The most common cause of death was liver insufficiency leading to hepatic failure, which suggests that accurate patient selection, based on careful assessment of baseline liver function parameters, may be a key factor to minimize the risk of treatment-related death and reduce liver-related adverse events.” – by Will Offit

Disclosure: Lencioni reports consulting for Guerbet, BTG and Bayer. Please see the full study for a list of all other researchers’ relevant financial disclosures.