Study Challenges Use of Doxorubicin Beads for Hepatocellular Carcinoma
No difference between chemoembolization using doxorubicin-eluting microspheres and embolization using microspheres alone.
There appears to be no difference between chemoembolization using doxorubicin-eluting microspheres and embolization using microspheres alone in patients with hepatocellular carcinoma (HCC) undergoing hepatic artery embolization, a study published in the Journal of Clinical Oncology has shown.1
Although transarterial chemoembolization is accepted therapy for HCC, no randomized trial has demonstrated superiority of chemoemboliization vs embolization.
Furthermore, the role of chemotherapy in embolization remains unclear. Therefore, researchers at Memorial Sloan Kettering Cancer Center in New York sought to compare the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres.
For the double-blind study, researchers enrolled 101 patients with HCC and randomly assigned them 1:1 to undergo embolization with microspheres alone or loaded with doxorubicin 150 mg. Of those, 22% were Barcelona Clinic Liver Cancer stage A and 78% were stage B or C.
Results showed that patients receiving microspheres alone had a 5.9% response rate according to RECIST 1.0 compared with 6.0% among patients receiving doxorubicin-eluting microspheres (difference, -0.1%; 95% CI: -9%-9%).
Researchers found that median progression-free survival was 6.2 months and 2.8 months, respectively (HR, 1.36; 95% CI: 0.91-2.05; P=.11).
There was also no significant difference in overall survival between the 2 treatment arms (19.6 months for microspheres alone vs 20.8 months for doxorubicin-eluting microspheres; HR, 1.11; 95% CI: 0.71-1.76; P=.64).
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In terms of safety, adverse events were reported 38% of patients in the embolization group compared with 40% of those in the chemoembolization group (P=.48).
“There was no apparent difference between the treatment arms,” the authors conclude. “These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.”
1. Brown KT, Do RK, Gonen M, et al. Randomized trial of hepatic artery embolization for hepatocellular carcinoma using doxorubicin-eluting microspheres compared with embolization with microspheres alone [published online ahead of print February 1, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.64.0821.