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Developments in TACE and SIRT treatment in patients
Date:4/26/2013

ti-centre pilot study suggest that a single-session of SIRT is as safe and effective as multiple sessions of TACE in a typical TACE patient cohort with unresectable HCC.

Patients were randomised to receive either TACE (n=15) or SIRT (n=13). Patients received a mean of 3.4 TACE interventions (median 2; range 1-11) or 1 SIRT procedure. Treatment response was assessed by local (using RECIST 1.0) and independent central (RECIST 1.1 and mRECIST) review. Median progression-free survival (RECIST 1.1) was 5.5 months (95%CI: 1.6- not reached) for TACE and 4.1 months (95%CI: 2.3-9.9) for SIRT (p=0.411). Overall survival did not differ by procedure (p=0.244).

The similar efficacy and safety of these two procedures presents a challenge for the design of a phase III trial for intermediate-stage HCC in terms of whether to use TACE or SIRT as the preferred treatment technique.

Finally, the SORAMIC European multicentre phase II clinical trial also showcased at the congress, evaluated the efficacy and safety of using a combination of SIRT and sorafenib for the treatment of HCC.

Data from the interim safety analysis has confirmed that SIRT as a sequential approach followed by an escalation scheme for sorafenib does not lead to increased toxicity. Interim analysis of the data showed a total number of adverse events of 196 and 220 in the combination and control arm, with grade 3-5 adverse events reaching 42 and 49, respectively (p>0.05).

SORAMIC continues to recruit and investigators are hopeful that the combination of SIRT and sorafenib will be shown to significantly enhance survival over sorafenib alone without increasing toxicity thus enabling to design large Phase III clinical trials.

Disclaimer: the data referenced in this release is based on the submitted abstract. More recent data may be presented at the International Liver Congress 2013.


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Contact: Dimple Natali
easlpressoffice@cohnwolfe.com
44-079-001-38904
European Association for the Study of the Liver
Source:Eurekalert

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