Also presented at the CIRSE meeting were the baseline data and demographics from the PRECISION V randomised clinical study. The baseline demographics were presented on behalf of the study investigators by Principle Investigator, Professor Johannes Lammer, Medical University of Vienna, Austria. PRECISION V is a 200-patient, international, prospective, randomised study of doxorubicin in the treatment of hepatocellular carcinoma (HCC) with Drug-Eluting Bead embolisation.
Lammer explained that PRECISION V was designed to assess the safety and efficacy of Biocompatible’s DC Bead™ loaded with doxorubicin compared with conventional transarterial chemoembolisation (TACE with doxorubicin). Nineteen European centres were involved in the study, across five countries (France, Germany, Switzerland, Austria and Greece). Patients received three treatments at baseline, two months and four months, and the follow-up period was six months.
Measured by magnetic resonance imaging (MRI), the primary endpoint of the study is to assess six month tumour response rate, in which the response criteria for necrosis is by the European Association for the Study of the Liver (EASL) for necrosis, and for tumour size is the Response Evaluation Criteria in Solid Tumors (RECIST).
Study design A total of 247 intermediate HCC patients (BCLC classification) were screened of which 212 were randomised. So far, of the 65 patients fully analysed, 32 were included in the DC Bead group, and 33 in the TACE group. Lammer and all investigators are blinded to the safety and efficacy data until all patients have completed all treatments and evaluations. The Safety Committee reviewed the interim data (first 100 patients) on Serious Adverse Events (SAEs) and has concluded that the trial should complete recruitment as planned. Patients recruited will continue to receive treatment on protocol until the end of 2007.
Treatment Protocol In the DC Bead arm of the study, the aim of each procedure was to deliver 2x2mL vials of DC Bead (total 4mL) loaded at 37.5mg/mL, that is, a total dose of 150mg of doxorubicin (one vial of 300-500µm followed by one vial of 500-700µm). Patients in the conventional TACE arm of the trial received doxorubicin at a dose of 50-75mg/m2 in each procedure to a maximum of 150mg.
Unifocal tumours were treated with selective segmental chemoembolisation, and in case of bilobar disease, embolisation was performed with both lobes being treated in a single session or if not possible, both lobes were treated within a three week period (see case example, right). As the final patients are still in their follow-up period, the first data on safety and efficacy from PRECISION V is expected to be reported in the second quarter of 2008.
