Abstract
Background & aim:
DC Bead, drug-eluting beads, was launched in Japan in February, 2014 for the treatment of HCC. Post-marketing surveillance has been conducted to examine the utilization, safety and efficacy of DC Bead under daily medical practice conditions. In this presentation, analysis results are reported focusing on the utilization and safety and efficacy of DC Bead.
Materials & Method:
This was a post-marketing, observational study conducted in 26 centers to evaluate the safety and effectiveness of DC Bead in Japanese patients with HCC. Patients were observed for 30 days following enrollment.
Results:
300 patients were enrolled from 26 centers in Japan. The number of patients included in the safety analysis was 282. Regarding adverse drug reactions, 232 events occurred in 119 patients (42.2%). The results of the evaluation of embolization performance, based on digital subtraction angiography findings, showed that “complete embolization” was observed in 137 patients, “intensive embolization” in 101 patients, “moderate embolization” in 35 patients, “mild embolization” in 4 patients, and “not evaluable” in 2 patients; the embolization success rate was 85.3% (238/279 patients).
Conclusion:
This study well demonstrated DC Bead to be an embolic agent providing effective and safe treatment of HCC under daily medical practice conditions in Japan.
