Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma

R Golfieri, E Giampalma, M Renzulli, R Cioni, I Bargellini, C Bartolozzi, A D Breatta, G Gandini, R Nani, D Gasparini, A Cucchetti, L Bolondi, F Trevisani, PRECISION ITALIA STUDY GROUP, Cristina Mosconi, Alberta Cappelli, Maria Cristina Galaverni, Patrizia Pini, Fabio Piscaglia, Francesca Benevento, Luca Giampaolo, Claudia Caprara, Rita Menichella, Marco Lenzi, Mauro Bernardi, Valentina Santi, Virginia Erroi, Giuseppe Mazzella, Antonio Colecchia, Lucia Montrone, Ramona Schiumerini, Giampaolo Bianchi, Marco Zoli, Gabriella Martini, Lucilla Fraticelli, Claudia Sama, Sonia Berardi, Carla Serra, Claudio Vignali, Francesca Bianchi, Valentina Vallini, Paola Carrai, Franco Filipponi, Sara Moneta, Enrica Pea, Stefano Giunta, Rodolfo Sacco, Angelo Ricchiuti, Giorgia di Fluri, Barbara Coco, Denis Rossato, Cristina Vighetti, Giacomo Battisti, Alessandro Rapellino, Patrizia Carucci, Loretta Cosso, Mario Rizzetto, Stefano Mirabella, Luisa Sturniolo, Giorgia Catalano, Mauro Salizzoni, Roberto Agazzi, Simone Limonta, Stefano Fagiuoli, Giuliana Verga, Giulia Magini, Giuseppe Aprile, Alessandro Vit, R Golfieri, E Giampalma, M Renzulli, R Cioni, I Bargellini, C Bartolozzi, A D Breatta, G Gandini, R Nani, D Gasparini, A Cucchetti, L Bolondi, F Trevisani, PRECISION ITALIA STUDY GROUP, Cristina Mosconi, Alberta Cappelli, Maria Cristina Galaverni, Patrizia Pini, Fabio Piscaglia, Francesca Benevento, Luca Giampaolo, Claudia Caprara, Rita Menichella, Marco Lenzi, Mauro Bernardi, Valentina Santi, Virginia Erroi, Giuseppe Mazzella, Antonio Colecchia, Lucia Montrone, Ramona Schiumerini, Giampaolo Bianchi, Marco Zoli, Gabriella Martini, Lucilla Fraticelli, Claudia Sama, Sonia Berardi, Carla Serra, Claudio Vignali, Francesca Bianchi, Valentina Vallini, Paola Carrai, Franco Filipponi, Sara Moneta, Enrica Pea, Stefano Giunta, Rodolfo Sacco, Angelo Ricchiuti, Giorgia di Fluri, Barbara Coco, Denis Rossato, Cristina Vighetti, Giacomo Battisti, Alessandro Rapellino, Patrizia Carucci, Loretta Cosso, Mario Rizzetto, Stefano Mirabella, Luisa Sturniolo, Giorgia Catalano, Mauro Salizzoni, Roberto Agazzi, Simone Limonta, Stefano Fagiuoli, Giuliana Verga, Giulia Magini, Giuseppe Aprile, Alessandro Vit

Abstract

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.

Figures

Figure 1
Figure 1
Summary flow chart of the study.
Figure 2
Figure 2
Local response of lesions treated. Abbreviations: CR=complete response; DC=disease control; OR=objective response.
Figure 3
Figure 3
Overall response of the entire liver according to mRECIST criteria. Abbreviations: CR=complete response; DC=disease control; OR=objective response.
Figure 4
Figure 4
Patient survival after cTACE (triangle plot) and DEB-TACE (square plot).

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