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Clinical Trial
. 2013 Apr 2;108(6):1252-9.
doi: 10.1038/bjc.2013.85. Epub 2013 Feb 28.

A randomised phase II/III trial of 3-weekly cisplatin-based sequential transarterial chemoembolisation vs embolisation alone for hepatocellular carcinoma

T Meyer  1 , A Kirkwood, M Roughton, S Beare, E Tsochatzis, D Yu, N Davies, E Williams, S P Pereira, D Hochhauser, A Mayer, R Gillmore, J O'Beirne, D Patch, A K Burroughs
Affiliations
Clinical Trial

A randomised phase II/III trial of 3-weekly cisplatin-based sequential transarterial chemoembolisation vs embolisation alone for hepatocellular carcinoma

T Meyer et al. Br J Cancer. .

Abstract

Background: Transarterial chemoembolisation (TACE) has not been shown to be superior to bland embolisation (TAE) for treatment of hepatocellular carcinoma (HCC).

Methods: We conducted a randomised phase II/III trial in patients with untreated HCC. Patients were randomised to TAE with polyvinyl alcohol (PVA) particles alone or sequential TACE (sTACE) in which cisplatin 50 mg was administered intrarterially 4-6 h before PVA embolisation. Treatment was repeated 3-weekly for up to three treatments. The primary endpoint was overall survival and secondary endpoints were progression-free survival, toxicity and response. Target sample sizes for phase II and III were 80 and 322.

Results: The trial was terminated at phase II after 86 patients had been randomised. Patients were well matched for prognostic criteria. All three planned treatments were given to 57.1% (TAE) and 56.8% (TACE) patients. Grade 3/4 toxicity occurred in 63.5% and 83.7%, respectively (P=0.019). End-of-treatment RECIST response (CR+PR) was 13.2 and 32.6% (P=0.04) (mRECIST 47.3% and 67.4) and median overall survival and progression-free survival was 17.3 vs 16.3 (P=0.74) months and 7.2 vs 7.5 (P=0.59), respectively.

Conclusion: Transarterial chemoembolisation according this novel schedule is feasible and associated with a higher response rate than TAE alone. The survival benefit of TACE over TAE remains unproven.

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Figures

Figure 1
Figure 1
Consort diagram.
Figure 2
Figure 2
(A) Progression-free survival. (B) overall survival.
Figure 3
Figure 3
Forrest plot for survival outcomes following TACE or TAE alone in patients with hepatocellular carcinoma in the five existing randomised controlled trials to date.
See this image and copyright information in PMC

References

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