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Randomized Controlled Trial
. 2014 Jul 15;111(2):255-64.
doi: 10.1038/bjc.2014.199. Epub 2014 Jun 17.

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

R Golfieri  1 , E Giampalma  1 , M Renzulli  1 , R Cioni  2 , I Bargellini  2 , C Bartolozzi  2 , A D Breatta  3 , G Gandini  3 , R Nani  4 , D Gasparini  5 , A Cucchetti  6 , L Bolondi  6 , F Trevisani  6 ; PRECISION ITALIA STUDY GROUP
Collaborators, Affiliations
Randomized Controlled Trial

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

R Golfieri et al. Br J Cancer. .

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.

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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).
See this image and copyright information in PMC

References

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