Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy

Abstract

BackgroundThe aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC).Material/MethodsThis was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria.ResultsTwenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment.A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25).ConclusionsThe use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime.

Outcome and Safety after 103 Radioembolizations with Yttrium-90 Resin Microspheres in 73 Patients with Unresectable Intrahepatic Cholangiocarcinoma—An Evaluation of Predictors

“…In comparison to our results with TARE, complication rate and gravidity of the complications was higher for RFA. Several studies differing in quality have examined the use of TACE for patients with unresectable ICC [28][29][30]. In the prospective study of Kiefer et al [28] with 62 ICC patients, PR, SD, and PD according to RECIST were reported in 11%, 64%, and 24% of patients, respectively.…”

Trans-arterial chemoembolization with degradable starch microspheres (DSM-TACE) versus selective internal radiation therapy (SIRT) in multifocal hepatocellular carcinoma

“…Iezzi et al (28,29) treated 40 patients with DSM-TACE who were dismissed or ineligible for Sorafenib with an OS of 11.3 months, a PFS of 6.4 months, and recommended DSM treatment as a safe and effective second-line option. Besides HCC, DSM-TACE was applied successfully in other entities such as intrahepatic cholangiocarcinoma (CCC) and patients with secondary liver malignancies, highlighting this treatment option and the possible combination with chemotherapeutic agents (30,31). TACE in general is associated with fewer AEs.…”

DEB-TACE with irinotecan versus C-TACE for unresectable intrahepatic cholangiocarcinoma: a prospective clinical study

“…Regarding safety, no therapy-related deaths occurred in our study, and only 2.5% (1 of 40) of the patients developed liver abscesses after DEB-TACE therapy, which is not a common occurrence. In a previous study, the most common side effects following TACE were abdominal pain, fever, and elevated transaminase levels ( Aliberti, et al, 2008 ; Carter and Martin Ii, 2009 ; Schicho et al, 2017 ). The incidence of side effects is relatively low, and typically no major adverse events occur ( Poggi et al, 2008 ).…”