Pharmacokinetics, Safety, and Efficacy of Chemoembolization with Doxorubicin-Loaded Tightly Calibrated Small Microspheres in Patients with Hepatocellular Carcinoma

• Published in: Cardiovascular and interventional radiology 2016-10, Vol.39 (10), p.1379-1391
• Main Authors: Malagari, Katerina, Kiakidis, Theodoros, Pomoni, Maria, Moschouris, Hippokratis, Emmanouil, Emmanouil, Spiridopoulos, Themis, Sotirchos, Vlasios, Tandeles, Savvas, Koundouras, Dimitrios, Kelekis, Alexios, Filippiadis, Dimitrios, Charokopakis, Angelos, Bouma, Evanthia, Chatziioannou, Achilles, Dourakis, Spyridon, Koskinas, John, Karampelas, Theodoros, Tamvakopoulos, Konstantinos, Kelekis, Nikolaos, Kelekis, Dimitrios
• Format: Article
• Language: English
• Subjects: ABUNDANCE; Aged; Aged, 80 and over; Antibiotics, Antineoplastic - administration & dosage; Antibiotics, Antineoplastic - pharmacokinetics; Carcinoma, Hepatocellular - therapy; Cardiology; Chemoembolization, Therapeutic - adverse effects; Chemoembolization, Therapeutic - methods; CHILDREN; Clinical Investigation; CONCENTRATION RATIO; DAMAGE; Disease-Free Survival; DOSES; DOXORUBICIN; Doxorubicin - administration & dosage; Doxorubicin - pharmacokinetics; ETIOLOGY; Female; Hepatitis B virus; Hepatitis C virus; HEPATOMAS; Humans; Imaging; Liver Neoplasms - therapy; Male; Medicine; Medicine & Public Health; MICROSPHERES; Middle Aged; MORTALITY; Nuclear Medicine; PATIENTS; Pilot Projects; PLASMA; Radiology; RADIOLOGY AND NUCLEAR MEDICINE; RANDOMNESS; RUPTURES; SAFETY; TOXICITY; Treatment Outcome; Ultrasound
• ISSN: 0174-1551; 1432-086X
• DOI: 10.1007/s00270-016-1382-6

Purpose This study examines safety, efficacy, and pharmacokinetics of chemoembolization with loadable microspheres ≤100 μm for hepatocellular carcinoma. Materials and Methods A pilot safety study was performed in 19 patients with size and dose escalation and then 52 patients were enrolled prospectively and randomly assigned to chemoembolization with TANDEM™ loaded with 150 or 100 mg of doxorubicin. Results The mean diameter of the tumors was 7.28 ± 2.09 cm (range 4–12) and distribution dominant/multiple 51.9/48.1 %. Child A/B distribution was 32/20 (61.5/38.5 %) and etiology HBV/HCV/HBV/HCV-hemochromatosis was 61.6/9.6/9.6/15.4 %. Twenty-five patients were assigned in the low and 27 in the high loading group. There was 1.92 % thirty-day mortality due to lesion rupture. Biliary damage was seen in 3 patients (5.7 %) in the high loading. Mean maximum plasma concentration of doxorubicin C max  ± SD was 284.9 ± 276.2 ng/mL for the high and 108.5 ± 77.6 ng/mL for the low loading ( p