Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial

What is it about?

Previous 5 randomised controlled trials have failed to show that combinations of transcatheter arterial chemoembolization (TACE) plus molecular targeted agents have clinical benefits in patients with hepatocellular carcinoma (HCC). Three of those 5 trials were trials comparing TACE plus sorafenib with TACE alone. We learned from these negative trials that treatment duration with sorafenib is the very important issue to improve patient outcome such as TTP or PFS as described by authors of post TACE and SPACE trials.

Therefore, we developed TACE specific PFS, unTACEable progression/TACE failure since appearance of intrahepatic new lesion or regrowth of treated tumour is not a treatment failure by TACE nor suggest moving to a next line of treatment, therefore, RECIST was not applied as a definition of progression in this trial. As a result, treatment duration with sorafenib turn out to be very long (38weeks) and TACE-specific PFS was much longer in TACE plus sorafenib group than that in TACE alone group. Other secondary endpoints were all improved in TACE/sorafenib combination group.

This is the first ever positive trial of TACE in combination with a molecular targeted agent, sorafenib, in patients with unresectable HCC, providing a practice changing result. In contrast to the five negative trials, the present trial assessed the efficacy of TACE plus sorafenib using an endpoint more suitable for a TACE combination trial, with this endpoint being consistent with those used in clinical practice.


Featured Image