PMID- 31321482 OWN - NLM STAT- MEDLINE DCOM- 20200120 LR - 20200120 IS - 1432-086X (Electronic) IS - 0174-1551 (Linking) VI - 42 IP - 11 DP - 2019 Nov TI - Five-Years Outcome Analysis of 142 Consecutive Hepatocellular Carcinoma Patients Treated with Doxorubicin Eluting Microspheres 30-60 mum: Results from a Single-Centre Prospective Phase II Trial. PG - 1551-1562 LID - 10.1007/s00270-019-02260-3 [doi] AB - PURPOSE: To assess prospectively long-term results of doxorubicin-loaded HepaSphere 30-60 mum in consecutive patients with hepatocellular carcinoma (HCC) not amenable to curative treatments. PATIENTS AND METHODS: Single-center study from June 2011 to December 2015 in 151 patients treated with 75 mg of doxorubicin per HepaSphere vial. Baseline: Barcelona Clinic Liver Cancer BCLC A/B was 49.3%/50.7%, and median diameter 6.1 cm (mean 6.7 +/- 2.0). Liver function, local response (mRECIST), liver time to progression (LTTP), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were recorded. RESULTS: Final analysis included 142 patients with median follow-up of 46.8 months (range 4-72) without grade 4/5 AEs, and 30-day mortality was 0%. Mean number of scheduled treatments was 2.6 (range 1-3) and on demand 3 (range 1-8). Complete response for single tumor 5 cm was 28.6% and 11.8%, respectively. OS was 31.0 months (mean 33.3 +/- 15.2; range 8-69), notably for BCLC A 41 months (mean 41.1 +/- 15.3; range 13-69) and for BCLC B 26.0 (mean 26.0 +/- 10.5; range 8-51). OS at 1, 3 and 5 years: 95.8%, 75.7% and 21.4% for BCLC A, and 94.4%, 36.1% and 2.7% for BCLC B. Median LTTP for BCLC A was 11 months (mean 11.9 +/- 4.7; range 3-24) and 7.5 for BCLC B (mean 7.9 +/- 2.9). Local response was significant for OS and LTTP (p < 0.0001), while size and lesion number affected LPFS and OS (p < 0.001). CONCLUSIONS: HepaSphere 30-60 mum loaded with doxorubicin provides a safe and effective treatment option for patients with HCC. FAU - Malagari, K AU - Malagari K AUID- ORCID: 0000-0002-1391-0965 AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. kmalag@otenet.gr. AD - Attikon Hospital, Chaidari, Greece. kmalag@otenet.gr. AD - Evgenidion Hospital, Athens, Greece. kmalag@otenet.gr. FAU - Moschouris, H AU - Moschouris H AD - Radiology Department of Tzanion General Hospital, Athens, Greece. FAU - Kiakidis, Th AU - Kiakidis T AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. AD - Evgenidion Hospital, Athens, Greece. FAU - Harward, S AU - Harward S AD - University of Massachusets Medical School, Worcester, MA, USA. FAU - Kelekis, A AU - Kelekis A AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. AD - Attikon Hospital, Chaidari, Greece. AD - Evgenidion Hospital, Athens, Greece. FAU - Vrakas, S AU - Vrakas S AD - Tzanion Hospital, Athens, Greece. FAU - Koundouras, D AU - Koundouras D AD - 2nd Clinic of Medicine and Hepatology Medical School, National and Kapodistrian University of Athens, Athens, Greece. AD - 2nd Clinic of Internal Medicine University of Athens Hippokration Hospital, Athens, Greece. FAU - Filipiadis, D AU - Filipiadis D AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. AD - Attikon Hospital, Chaidari, Greece. FAU - Glantzounis, G AU - Glantzounis G AD - Department of Surgery, University Hospital of Ioannina (UOI), Ioannina, Greece. FAU - Emmanouil, E AU - Emmanouil E AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. AD - Evgenidion Hospital, Athens, Greece. FAU - Chatziioannou, A AU - Chatziioannou A AD - Evgenidion Hospital, Athens, Greece. AD - 1st Department of Radiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece. FAU - Vergadis, V AU - Vergadis V AD - Radiology Department of Laikon University Hospital, Athens, Greece. FAU - Elefsiniotis, I AU - Elefsiniotis I AD - Department of Internal Medicine and Hepatology Unit, Agioi Anargyroi General and Oncology Hospital of Kifissia Hospital Timiou Stavrou and Noufaron, Kalyftaki, Athens, Greece. FAU - Koskinas, J AU - Koskinas J AD - 2nd Clinic of Medicine and Hepatology Medical School, National and Kapodistrian University of Athens, Athens, Greece. AD - 2nd Clinic of Internal Medicine University of Athens Hippokration Hospital, Athens, Greece. FAU - Dourakis, S AU - Dourakis S AD - 2nd Clinic of Medicine and Hepatology Medical School, National and Kapodistrian University of Athens, Athens, Greece. AD - 2nd Clinic of Internal Medicine University of Athens Hippokration Hospital, Athens, Greece. FAU - Kelekis, N AU - Kelekis N AD - 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece. AD - Attikon Hospital, Chaidari, Greece. AD - Evgenidion Hospital, Athens, Greece. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20190718 PL - United States TA - Cardiovasc Intervent Radiol JT - Cardiovascular and interventional radiology JID - 8003538 RN - 0 (Antibiotics, Antineoplastic) RN - 80168379AG (Doxorubicin) SB - IM MH - Aged MH - Antibiotics, Antineoplastic/administration & dosage/*therapeutic use MH - Carcinoma, Hepatocellular/*drug therapy MH - Doxorubicin/administration & dosage/*therapeutic use MH - Drug Delivery Systems/*methods MH - Female MH - Follow-Up Studies MH - Humans MH - Liver Neoplasms/*drug therapy MH - Male MH - *Microspheres MH - Prospective Studies MH - Survival Analysis MH - Treatment Outcome OTO - NOTNLM OT - Chemoembolization OT - Drug-eluting beads-microspheres OT - Drug-eluting microspheres-DEM chemoembolization (DEMs)-(DEM TACE) OT - HepaSphere OT - Hepatocellular carcinoma (HCC) OT - Long-term survival HCC EDAT- 2019/07/20 06:00 MHDA- 2020/01/21 06:00 CRDT- 2019/07/20 06:00 PHST- 2019/01/08 00:00 [received] PHST- 2019/06/03 00:00 [accepted] PHST- 2019/07/20 06:00 [pubmed] PHST- 2020/01/21 06:00 [medline] PHST- 2019/07/20 06:00 [entrez] AID - 10.1007/s00270-019-02260-3 [pii] AID - 10.1007/s00270-019-02260-3 [doi] PST - ppublish SO - Cardiovasc Intervent Radiol. 2019 Nov;42(11):1551-1562. doi: 10.1007/s00270-019-02260-3. Epub 2019 Jul 18.