Optimal technique and response of doxorubicin beads in hepatocellular cancer: bead size and dose

Abstract

Background/AimsIt has been shown that the drug-eluting beads loaded with doxorubicin (DEBDOX) are effective for the treatment of hepatocellular carcinoma (HCC). However, the optimal safety and efficacy still remain to be established by using various bead sizes, doxorubicin doses, and the degree of stasis.The aim of this study was to determine the optimal safety and efficacy of DEBDOX in the treatment of HCC.MethodsAnalysis of a 503-patient prospective, multicenter, multinational Bead Registry Database from 2007 to 2010 identified 206 patients who had been treated for HCC with DEBDOX. Primary endpoints were to compare safety, tolerance, response rates, and overall survival based on bead size (100-300, 300-500, 500-700, and 700-900 µm), number of vials, doxorubicin dose, and degree of stasis.ResultsIn total, 206 patients underwent 343 treatments. The use of all four bead sizes was similar based on Child-Pugh class and Okuda stage, with a significantly higher use (50%) of beads of size 100-300 µm in patients with portal vein thrombosis (P=0.05). Significant differences were seen for the number of median treatments, median doxorubicin dose, lobar infusion), and degree of complete stasis. The rate of adverse events was higher for larger beads than for smaller beads (28% vs. 16%; P=0.02).ConclusionsBead size and dose may vary according to disease distribution. Smaller beads offer the opportunity for repeated treatments, a larger cumulative dose delivery, a lesser degree of complete stasis, and fewer adverse events.

Transarterial Hepatic Chemoembolization with 70–150 µm Drug-Eluting Beads: Assessment of Clinical Safety and Liver Toxicity Profile

“…Third, efficacy (response rate) was not recorded; this was an intentional omission because the present study was not designed to assess response in view of the obvious selection bias of the patient study population and the intrinsic limitations in finding a control group. Finally, the assessment of the degree of stasis of the selected vessels could potentially provide some relevant association with the incidence of LBI, as previously reported (4). Because of the lack of consensus on how to assess the degree of stasis of a treated vessel and the retrospective nature of our study, this variable was not incorporated in the analysis.…”

“…Despite the reported benefits, fundamental questions remain with respect to optimal particle size and type and chemotherapeutic dose for clinical use (3,4). Existing data regarding the use of particles sized 100–300 μm, 300–500 μm, and 500–700 μm show adverse event (AE) rates ranging from 10% to 58%, with fewer AEs occurring with the use of smaller particles (4–6).…”

“…Despite the reported benefits, fundamental questions remain with respect to optimal particle size and type and chemotherapeutic dose for clinical use (3,4). Existing data regarding the use of particles sized 100–300 μm, 300–500 μm, and 500–700 μm show adverse event (AE) rates ranging from 10% to 58%, with fewer AEs occurring with the use of smaller particles (4–6). The introduction of a new class of DEBs with a nominal bead size of 70–150 μm (LC/DC Bead M1 ; Biocompatibles UK Ltd, Farnham, Surrey, United Kingdom) has increased the options for therapeutic drug delivery and raised the issue of how these smallest DEBs can be best incorporated into clinical practice.…”

Transarterial therapy: An evolving treatment modality of hepatocellular carcinoma

“…The data from a prospective, non-controlled, repeat treatment registry of 206 patients undergoing 343 treatments for HCC indicated that smaller beads offer the opportunity for repeated treatments, a larger cumulative dose delivery, a lesser degree of complete stasis, and fewer adverse events. [ 58 ] The recommended treatment dose range reported by the PRECISION study[ 47 ] is 100-150 mg per patient, which was shown to be safe and effective even at the highest dose. [ 46 ] Dose adjustments for bilirubin levels may also be used, as in Varela et al .…”

Drug-eluting Beads in the Treatment of Hepatocellular Carcinoma and Colorectal Cancer Metastases to the Liver

“…Better tumour penetration of small (100-300 μm) versus larger (300-500 μm) microspheres has been demonstrated in VX2 liver tumour. 62 Potential benefits of small microspheres have been reported in a prospective multi-institutional non-randomised registry for HCC patients 63 and are also suggested for hmCRC patients. [64][65][66][67] In a recent study, increased benefit with decreased size has been shown, with an approximately twofold improved drug coverage in swine kidney (70-150 μm versus 100-300 μm).…”