Transarterial Chemoembolization of Hepatocellular Carcinoma with Idarubicin-Loaded Tandem Drug-Eluting Embolics

Abstract

: Objective: To describe the responses, toxicities and outcomes of HCC patients treated by transarterial chemoembolization (TACE) using idarubicin-loaded TANDEM beads. Materials and Methods: Seventy-two consecutive patients (mean age: 71 years (58–84 years)) with HCC were treated by TACE using idarubicin-loaded TANDEM in a first line, over a five-year period. Most patients (89%) had liver cirrhosis classified as Child–Pugh A (90%). BCLC B classification applied in 85% of cases. Baseline tumor burden was limited to one to three nodules in 92% of cases, unilobar in 88% cases, with a median tumor diameter of 55 mm (range: 13–150 mm). Toxicity was assessed using NCI CTC AE v4.0. Response was assessed using mRECIST criteria. Time-to-treatment failure (TTTF) and overall survival (OS) were also calculated based on Kaplan–Meier method. Result: Of 141 TACE sessions performed with bead sizes of 100 and 75 µm in 42 (29.8%) and 99 (70.2%) sessions, respectively. In 78% of all TACE sessions, the full dose of idarubicin-loaded beads was injected. Grade 3–4 AE were observed after 73 (52%) sessions, most of them being biological. Multi-organ failure was observed three days after the first TACE in a Child B patients, unfortunately leading to death. Overall, the best objective response rate (ORR) was 65%. Median follow-up lasted 14.3 months (95% CI: 11.2–18.8 months). Median TTTF and OS were 14.4 months (95% CI: 7.2–24.6 months) and 34.6 months (95% CI: 24.7—not reached) respectively. Conclusion: In this retrospective study involving well-selected HCC patients, high ORR and long TTTF and OS are observed after TACE using idarubicin-loaded TANDEM. A randomized trial is needed.

Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry

“…However, it remains longer than the median 6.6 months PFS reported by Guiu and colleagues with idarubicin, and longer than the 7.7-month PFS reported by Roth and colleagues when comparing idarubicin and doxorubicin [ 31 , 32 ]. TACE with idarubicin has gained a lot of interest in recent years and the results obtained in our study are among the best reported so far [ 15 , 16 , 31 , 32 ].…”

“…LifePearl™ can be loaded with various anthracyclines, such as doxorubicin, epirubicin and idarubicin, for DEM-TACE in the treatment of HCC. The data on safety and efficacy of idarubicin started to emerge only in recent years [ 15 , 16 ]; epirubicin is the preferential drug in some countries, while doxorubicin remains the most used drug for HCC treatment. The main purpose of this study was to assess tolerance and toxicity (hepatobiliary and systemic), safety and tumor response after DEM-TACE with LifePearl™ microspheres loaded with anthracyclines in a real-life setting.…”

Chinese expert consensus on technical recommendations for the standard operation of drug-eluting beads for transvascular embolization

“…In 2004, British BTG plc developed and launched DC Bead, the world's first drug-eluting bead onto which doxorubicin and irinotecan can be loaded, which then quickly obtained approval from various European and American organizations for application in the treatment of primary and secondary liver cancer (15)(16)(17)(18). In the years that followed, several drug-eluting microspheres were launched successively, including HepaSphere (19), CalliSpheres (20) and TANDEM (21). Drug-eluting microspheres come in a variety of sizes.…”

The short-term safety and efficacy of TANDEM microspheres of various sizes and doxorubicin loading concentrations for hepatocellular carcinoma treatment

“…The recommended maximum dose of doxorubicin and irinotecan is 50 mg/mL. Several recent randomized controlled trials and retrospective cohort studies have shown the clinical values of drug-loadable TANDEM using microspheres of different sizes with improved pharmacokinetic characteristics 29 – 31 . However, most studies have used microspheres of a specific diameter range or two sizes simultaneously for HCC treatment 32 , 33 .…”