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

Spela Korsic

Spela Korsic

  • Clinical Institute of Radiology, University Medical Centre LjubljanaLjubljana, Slovenia
  • Faculty of Medicine, University of LjubljanaLjubljana, Slovenia
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Korsic, Spela
, 
Josko Osredkar

Josko Osredkar

  • Institute of Clinical Chemistry and Biochemistry, University Medical Centre LjubljanaLjubljana, Slovenia
  • Faculty of Pharmacy, University of LjubljanaLjubljana, Slovenia
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Osredkar, Josko
, 
Alojz Smid

Alojz Smid

  • Faculty of Medicine, University of LjubljanaLjubljana, Slovenia
  • Department of Gastroenterology and Hepatology, University Medical Centre LjubljanaLjubljana, Slovenia
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Smid, Alojz
, 
Klemen Steblovnik

Klemen Steblovnik

  • Faculty of Medicine, University of LjubljanaLjubljana, Slovenia
  • Department of Cardiology, University Medical Centre LjubljanaLjubljana, Slovenia
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Steblovnik, Klemen
, 
Mark Popovic

Mark Popovic

Biotechnical Faculty, University of LjubljanaLjubljana, Slovenia
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Popovic, Mark
, 
Igor Locatelli

Igor Locatelli

Faculty of Pharmacy, University of LjubljanaLjubljana, Slovenia
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Locatelli, Igor
, 
Jurij Trontelj

Jurij Trontelj

Faculty of Pharmacy, University of LjubljanaLjubljana, Slovenia
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Trontelj, Jurij
 and 
Peter Popovic

Peter Popovic

  • Clinical Institute of Radiology, University Medical Centre LjubljanaLjubljana, Slovenia
  • Faculty of Medicine, University of LjubljanaLjubljana, Slovenia
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Popovic, Peter
  
Oct 04, 2024
Idarubicin-loaded drug-eluting microspheres transarterial chemoembolization for intermediate stage hepatocellular carcinoma: safety, efficacy, and pharmacokinetics's Cover Image
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Article Category: Research Article
Published Online: Oct 04, 2024
Page range: 517 - 526
Received: Aug 05, 2024
Accepted: Aug 28, 2024
DOI: https://doi.org/10.2478/raon-2024-0052
Keywords
© 2024 Spela Korsic et al., published by Sciendo
This work is licensed under the Creative Commons Attribution 4.0 International License.

FIGURE 1.

CT slices showing a mRECIST partial response to idarubicin-loaded drug-eluting microspheres (DEMIDA) - transarterial chemoembolization (TACE) in the VIII. segment of cirrhotic liver. (A) Baseline CT showing multifocal hepatocellular carcinoma (HCC). The diameter of the largest tumour was 38 mm; (B) Only minimally enhancing largest target lesion at the first treatment response evaluation, the diameter of viable lesion was 4 mm.
CT slices showing a mRECIST partial response to idarubicin-loaded drug-eluting microspheres (DEMIDA) - transarterial chemoembolization (TACE) in the VIII. segment of cirrhotic liver. (A) Baseline CT showing multifocal hepatocellular carcinoma (HCC). The diameter of the largest tumour was 38 mm; (B) Only minimally enhancing largest target lesion at the first treatment response evaluation, the diameter of viable lesion was 4 mm.

FIGURE 2.

Kaplan-Meier curve for overall survival.
Kaplan-Meier curve for overall survival.

FIGURE 3.

Geometric mean plasma concentration profiles for idarubicin (blue) and idarubicinol (purple) (n = 31). Error bars indicate first and third quartiles of plasma concentrations.
Geometric mean plasma concentration profiles for idarubicin (blue) and idarubicinol (purple) (n = 31). Error bars indicate first and third quartiles of plasma concentrations.

FIGURE 4.

Idarubicinol (A) and combined idarubicin-idarubicinol (B) plasma concentrations at 72 hours post-procedure in patients with objective response to treatment or progressive disease (n = 29).
Idarubicinol (A) and combined idarubicin-idarubicinol (B) plasma concentrations at 72 hours post-procedure in patients with objective response to treatment or progressive disease (n = 29).

Baseline patient's demographic, clinical, laboratory and imaging characteristics

Sex, number of patients (%)
  Male/female 28 (90.3)/3 (9.7)
Age, years
  Mean ± SD 70.6 ± 6.7
Cirrhosis, n. (%)
  Yes/No 30 (96.8)/1 (3.2)
Cirrhosis aetiology, n. (%)
  Ethylic 21 (67.7)
  NASH 4 (12.9)
  Hemochromatosis 2 (6.5)
  HBV 1 (3,2)
  HCV 1 (3,2)
  Cryptogenic 1 (3,2)
Portal hypertension, n. (%)
  Yes/No 21 (67.7)/10 (32.3)
Ascites, n. (%)
  Yes/No 10 (32.3)/21(67.7)
Laboratory characteristics
  GGT, median (range) [μkat/L] 1.72 (0.24–14.83)
  AST, mean ± SD [μkat/L] 0.80 ± 0.26
  ALT, mean ± SD [μkat/L] 0.71 ± 0.39
  Total bilirubin, mean ± SD [μmol/L] 25.03 ± 15.9
  Albumin, mean ± SD [g/L] 40.90 ± 5.00
  AFP, median (range) [kU/L] 5.3 (1–4062.5)
Child-Pugh score (n = 30)
  Mean points ± SD 5.8 ± 1.0
Child-Pugh class (n = 30)
  A/B, n (%) 23 (76.7)/7 (23.3)
Imaging characteristics
  Number of lesions, mean ± SD [mm] 3.1 ± 2.1
  Diameter of largest lesion, mean ± SD [mm] 44.8 ± 23.0
  Cumulative diameter of lesions, mean ± SD [mm] 75.7 ± 39.8
  Unilobar disease, n (%) 16 (51.6)
  Bilobar disease, n (%) 15 (48.4)
LVEF (%)
  Mean ± SD 64.1 ± 8.7
Language:
English
Publication timeframe:
4 times per year
Journal Subjects:
Medicine, Clinical Medicine, Internal Medicine, Haematology, Oncology, Radiology
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