Idarubicin-loaded drug-eluting microspheres transarterial chemoembolization for intermediate stage hepatocellular carcinoma: safety, efficacy, and pharmacokinetics

Authors

  • Špela Koršič Clinical Institute of Radiology, University Medical Centre Ljubljana and Faculty of Medicine, University of Ljubljana
  • Joško Osredkar Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia and Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia
  • Alojz Šmid Department of Gastroenterology and Hepatology, University Medical Centre Ljubljana, Japljeva ulica 2, 1000 Ljubljana, Slovenia and Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia
  • Klemen Steblovnik Department of Cardiology, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia and Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia
  • Mark Popović Biotechnical Faculty, University of Ljubljana, Jamnikarjeva ulica 101, 1000 Ljubljana, Slovenia
  • Igor Locatelli Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia
  • Peter Popović Clinical Institute of Radiology, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia and Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.
  • Jurij Trontelj Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia

Abstract

Background. Transarterial chemoembolization (TACE) is the treatment of choice for the intermediate stage hepatocellular carcinoma (HCC). Doxorubicin remains the most used chemotherapeutic agent in TACE, although in vitro screening has demonstrated that idarubicin exhibits greater cytotoxicity against HCC. This study aimed to evaluate safety, efficacy, and pharmacokinetics of idarubicin-loaded drug-eluting microspheres TACE (DEMIDA-TACE) in intermediate stage HCC patients.   

Patients and methods. Between September 2019 and December 2021, 31 consecutive intermediate stage HCC patients (96.8% cirrhotic) were included to this study. 2 mL of LifePearlTM microspheres (100 mm) loaded with 10 mg of 1 mg/mL idarubicin were used for treatment. The adverse events, objective response rate (ORR), progression free survival (PFS), time to TACE untreatable progression (TTUP), median overall survival (mOS), and pharmacokinetics were evaluated.

Results. There were 68 TACE procedures performed. Adverse events grade ≥ 3 were noted after 29.4% procedures. The ORR was 83.9%, median PFS and TTUP were 10.5 months (95% CI: 6.8 – 14.3 months) and 24.6 months (95% CI: 11.6 – 37.6 months), respectively. Median OS was 36.0 months (95% CI: 21.1 – 50.9 months). Significant differences between patients achieving OR and those with PD were observed regarding idarubicinol and combined idarubicin-idarubicinol plasma concentrations at 72 hours post-procedure, higher plasma concentrations were observed in patients achieving OR (p=0.014 and 0.014; cut-off values 1.2 and 1.29 ng/mL, respectively).

Conclusions. DEMIDA-TACE emerges as a safe and effective method of treatment for the intermediate stage HCC with low rates of adverse events alongside high tumor response, favourable disease control and overall survival. Idarubicinol and combined idarubicin-idarubicinol plasma concentrations at 72 hours post-procedure may serve as prognostic factors for achieving OR.

Downloads

Additional Files

Published

2024-11-26

How to Cite

Koršič, Špela, Osredkar, J., Šmid, A., Steblovnik, K., Popović, M., Locatelli, I., … Trontelj, J. (2024). Idarubicin-loaded drug-eluting microspheres transarterial chemoembolization for intermediate stage hepatocellular carcinoma: safety, efficacy, and pharmacokinetics. Radiology and Oncology, 58(4), 517–526. Retrieved from https://radioloncol.com/index.php/ro/article/view/4475

Issue

Section

Radiology