PMID- 36653660 OWN - NLM STAT- MEDLINE DCOM- 20230316 LR - 20230316 IS - 1432-086X (Electronic) IS - 0174-1551 (Linking) VI - 46 IP - 3 DP - 2023 Mar TI - Safety, Efficacy and Distribution of Doxorubicin Loaded Radiopaque Beads in Chemoembolization in Intermediate Stage Hepatocellular Carcinoma (HCC) with Correlation with Local Response. PG - 337-349 LID - 10.1007/s00270-022-03346-1 [doi] AB - PURPOSE: The primary objectives of this study were to evaluate safety, and efficacy of Transarterial Chemoembolization (TACE) using doxorubicin-loaded radiopaque microspheres (DC Bead LUMI) for the treatment of early and intermediate stage Hepatocellular Carcinoma (HCC) not amenable for curative treatments. Distribution of the microspheres was correlated with results post embolization. MATERIALS AND METHODS: This was a prospective, single arm, open label study. The primary outcome measures were distribution of the radiopaque microspheres as showed by computerized tomography (CT) and local response measured by modified Response Evaluation Criteria (mRECIST) after Magnetic Resonance Imaging (MRI). Secondary measures were Time to Progression (TTP) and Overall Survival (OS). RESULTS: Fifty patients were enrolled over 36 months. Median age was 69.0 years; mean sum of target lesions diameters was 78.6 +/- 36.8 mm. There were no Grade 4 or 5 adverse events (AEs). At 6 months Complete Response (CR) (18%), Partial Response (PR) (62%), Objective Response OR (80%) and Stable Disease (SD) (20%) were recorded. Before embolization, Diffusion Weighted Imaging (DWI) showed high signal (restricted diffusion). Post procedure, patients with dense deposition (< 5 mm distance of microsphere aggregations) showed 100% absence of enhancement and no restriction in 30.6%. Median TTP was 8.3 months. TTP for patients with CR was 13.3 months and 7.2 and 5.6 for PR and SD, respectively. At 6 and 36 months, survival was 94% and 34%, respectively. CONCLUSION: DC Bead LUMI is well tolerated and effective in early and intermediate stage HCC with maximal necrosis obtained in dense deposition in the target. CI - (c) 2023. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). FAU - Malagari, Kappa AU - Malagari Kappa AUID- ORCID: 0000-0002-1391-0965 AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. kmalag@otenet.gr. FAU - Kiakidis, Th AU - Kiakidis T AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. FAU - Moschouris, Hip AU - Moschouris H AD - Department of Tzanion, General Hospital Pireus, Pireus, Greece. FAU - Deutsch, M AU - Deutsch M AD - Second Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece. FAU - Tanteles, S AU - Tanteles S AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. FAU - Pantou, Eir AU - Pantou E AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. FAU - Panagiotou, I AU - Panagiotou I AD - Palliative Care, Agios Savvas Anticancer Hospital, Athens, Greece. FAU - Koskinas, J AU - Koskinas J AD - University Hospital of Ioannina, Ioannina, Greece. FAU - Glantzounis, G K AU - Glantzounis GK AD - University Hospital of Ioannina, Ioannina, Greece. FAU - Alexopoulou, A AU - Alexopoulou A AD - Second Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece. FAU - Filippiadis, D AU - Filippiadis D AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. FAU - Brountzos, E AU - Brountzos E AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. FAU - Kelekis, N AU - Kelekis N AD - 2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece. LA - eng GR - 50/The study was supported by 'Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation/ PT - Journal Article DEP - 20230118 PL - United States TA - Cardiovasc Intervent Radiol JT - Cardiovascular and interventional radiology JID - 8003538 RN - 80168379AG (Doxorubicin) RN - 0 (Antibiotics, Antineoplastic) SB - IM MH - Humans MH - Aged MH - *Carcinoma, Hepatocellular/therapy/drug therapy MH - *Liver Neoplasms/therapy/drug therapy MH - Prospective Studies MH - *Chemoembolization, Therapeutic/methods MH - Doxorubicin MH - Microspheres MH - Treatment Outcome MH - Antibiotics, Antineoplastic OTO - NOTNLM OT - Barcelona clinic liver cancer (BCLC) OT - DC bead LUMI OT - Drug eluting microspheres OT - Hepatocellular carcinoma (HCC) OT - Radiopaque loadable microspheres EDAT- 2023/01/19 06:00 MHDA- 2023/03/17 06:00 CRDT- 2023/01/18 23:28 PHST- 2022/03/29 00:00 [received] PHST- 2022/12/14 00:00 [accepted] PHST- 2023/01/19 06:00 [pubmed] PHST- 2023/03/17 06:00 [medline] PHST- 2023/01/18 23:28 [entrez] AID - 10.1007/s00270-022-03346-1 [pii] AID - 10.1007/s00270-022-03346-1 [doi] PST - ppublish SO - Cardiovasc Intervent Radiol. 2023 Mar;46(3):337-349. doi: 10.1007/s00270-022-03346-1. Epub 2023 Jan 18.