PMID- 24937669 OWN - NLM STAT- MEDLINE DCOM- 20141111 LR - 20231104 IS - 1532-1827 (Electronic) IS - 0007-0920 (Print) IS - 0007-0920 (Linking) VI - 111 IP - 2 DP - 2014 Jul 15 TI - Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. PG - 255-64 LID - 10.1038/bjc.2014.199 [doi] AB - BACKGROUND: Transcatheter arterial chemoembolisation (TACE) is the treatment of choice for intermediate stage hepatocellular carcinoma (HCC). Doxorubicin-loaded drug-eluting beads (DEB)-TACE is expected to improve the performance of conventional TACE (cTACE). The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression (TTP), adverse events (AEs), and 2-year survival. METHODS: Patients were randomised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death. Transcatheter arterial chemoembolisation was repeated 'on-demand'. RESULTS: We enrolled 177 patients: 89 underwent DEB-TACE and 88 cTACE. The median number of procedures was 2 in each arm, and the in-hospital stay was 3 and 4 days, respectively (P=0.323). No differences were found in local and overall tumour response. The median TTP was 9 months in both arms. The AE incidence and severity did not differ between the arms, except for post-procedural pain, more frequent and severe after cTACE (P<0.001). The 1- and 2-year survival rates were 86.2% and 56.8% after DEB-TACE and 83.5% and 55.4% after cTACE (P=0.949). Eastern Cooperative Oncology Group (ECOG), serum albumin, and tumour number independently predicted survival (P<0.05). CONCLUSIONS: The DEB-TACE and the cTACE are equally effective and safe, with the only advantage of DEB-TACE being less post-procedural abdominal pain. FAU - Golfieri, R AU - Golfieri R AD - Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy. FAU - Giampalma, E AU - Giampalma E AD - Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy. FAU - Renzulli, M AU - Renzulli M AD - Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy. FAU - Cioni, R AU - Cioni R AD - Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. FAU - Bargellini, I AU - Bargellini I AD - Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. FAU - Bartolozzi, C AU - Bartolozzi C AD - Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. FAU - Breatta, A D AU - Breatta AD AD - Diagnostic Imaging Division, Department of Medical and Surgical Disciplines University of Turin, AOU S. Giovanni Battista, Turin, Italy. FAU - Gandini, G AU - Gandini G AD - Diagnostic Imaging Division, Department of Medical and Surgical Disciplines University of Turin, AOU S. Giovanni Battista, Turin, Italy. FAU - Nani, R AU - Nani R AD - CeLiveR, Ospedali Riuniti di Bergamo, Bergamo, Italy. FAU - Gasparini, D AU - Gasparini D AD - Department of Radiologic Sciences, University Hospital, S. Maria della Misericordia, Udine, Italy. FAU - Cucchetti, A AU - Cucchetti A AD - Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy. FAU - Bolondi, L AU - Bolondi L AD - Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy. FAU - Trevisani, F AU - Trevisani F AD - Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy. CN - PRECISION ITALIA STUDY GROUP LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20140617 PL - England TA - Br J Cancer JT - British journal of cancer JID - 0370635 RN - 0 (Antibiotics, Antineoplastic) RN - 80168379AG (Doxorubicin) SB - IM MH - Aged MH - Antibiotics, Antineoplastic/*administration & dosage MH - Carcinoma, Hepatocellular/*therapy MH - Chemoembolization, Therapeutic/*methods MH - Doxorubicin/*administration & dosage MH - Female MH - Humans MH - Liver Neoplasms/*therapy MH - Male MH - Prospective Studies MH - Survival Rate PMC - PMC4102934 FIR - Mosconi, Cristina IR - Mosconi C FIR - Cappelli, Alberta IR - Cappelli A FIR - Galaverni, Maria Cristina IR - Galaverni MC FIR - Pini, Patrizia IR - Pini P FIR - Piscaglia, Fabio IR - Piscaglia F FIR - Benevento, Francesca IR - Benevento F FIR - Giampaolo, Luca IR - Giampaolo L FIR - Caprara, Claudia IR - Caprara C FIR - Menichella, Rita IR - Menichella R FIR - Lenzi, Marco IR - Lenzi M FIR - Bernardi, Mauro IR - Bernardi M FIR - Santi, Valentina IR - Santi V FIR - Erroi, Virginia IR - Erroi V FIR - Mazzella, Giuseppe IR - Mazzella G FIR - Colecchia, Antonio IR - Colecchia A FIR - Montrone, Lucia IR - Montrone L FIR - Schiumerini, Ramona IR - Schiumerini R FIR - Bianchi, Giampaolo IR - Bianchi G FIR - Zoli, Marco IR - Zoli M FIR - Martini, Gabriella IR - Martini G FIR - Fraticelli, Lucilla IR - Fraticelli L FIR - Sama, Claudia IR - Sama C FIR - Berardi, Sonia IR - Berardi S FIR - Serra, Carla IR - Serra C FIR - Vignali, Claudio IR - Vignali C FIR - Bianchi, Francesca IR - Bianchi F FIR - Vallini, Valentina IR - Vallini V FIR - Carrai, Paola IR - Carrai P FIR - Filipponi, Franco IR - Filipponi F FIR - Moneta, Sara IR - Moneta S FIR - Pea, Enrica IR - Pea E FIR - Giunta, Stefano IR - Giunta S FIR - Sacco, Rodolfo IR - Sacco R FIR - Ricchiuti, Angelo IR - Ricchiuti A FIR - di Fluri, Giorgia IR - di Fluri G FIR - Coco, Barbara IR - Coco B FIR - Rossato, Denis IR - Rossato D FIR - Vighetti, Cristina IR - Vighetti C FIR - Battisti, Giacomo IR - Battisti G FIR - Rapellino, Alessandro IR - Rapellino A FIR - Carucci, Patrizia IR - Carucci P FIR - Cosso, Loretta IR - Cosso L FIR - Rizzetto, Mario IR - Rizzetto M FIR - Mirabella, Stefano IR - Mirabella S FIR - Sturniolo, Luisa IR - Sturniolo L FIR - Catalano, Giorgia IR - Catalano G FIR - Salizzoni, Mauro IR - Salizzoni M FIR - Agazzi, Roberto IR - Agazzi R FIR - Limonta, Simone IR - Limonta S FIR - Fagiuoli, Stefano IR - Fagiuoli S FIR - Verga, Giuliana IR - Verga G FIR - Magini, Giulia IR - Magini G FIR - Aprile, Giuseppe IR - Aprile G FIR - Vit, Alessandro IR - Vit A EDAT- 2014/06/18 06:00 MHDA- 2014/11/12 06:00 PMCR- 2015/07/15 CRDT- 2014/06/18 06:00 PHST- 2013/12/20 00:00 [received] PHST- 2014/03/09 00:00 [revised] PHST- 2014/03/20 00:00 [accepted] PHST- 2014/06/18 06:00 [entrez] PHST- 2014/06/18 06:00 [pubmed] PHST- 2014/11/12 06:00 [medline] PHST- 2015/07/15 00:00 [pmc-release] AID - bjc2014199 [pii] AID - 10.1038/bjc.2014.199 [doi] PST - ppublish SO - Br J Cancer. 2014 Jul 15;111(2):255-64. doi: 10.1038/bjc.2014.199. Epub 2014 Jun 17.