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| |  Drug-Eluting Beads Significantly Reduce Doxorubicin Toxicity in Patients With HCC: Presented at EASL By Cameron Johnston COPENHAGEN, Denmark -- April 29, 2009 -- Drug-eluting glass "beads" that have been loaded with doxorubicin may prove superior to the conventional form of transarterial chemoembolisation (c-TACE) as a treatment for intermediate-stage hepatic-cell carcinoma (HCC), researchers noted here at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). The drug-eluting bead transarterial chemoembolisation (DEB-TACE) produced significantly greater objective response and disease control among patients who had a more advanced stage of the disease during a trial of 200 patients treated with either DEB-TACE or c-TACE. Adverse events were significantly reduced among patients who received DEB-TACE as well. The total load of the drug injected was the equivalent to 150 mg of doxorubicin. Ordinarily, c-TACE involves doxorubicin in an oil emulsion injected directly into the tumour, noted coauthor Katrina Malagari, MD, University of Athens, Athens, Greece, at an oral presentation here on April 25. It was hypothesised, however, that DEB-TACE may be superior because the glass beads moderate the doxorubicin uptake, and provide a more gradual, longer-lasting treatment. Patients were stratified according to their Child-Pugh stage, Eastern Cooperative Oncology Group (ECOG) performance status, bilobular or unilobular disease, and prior curative treatments. Tumour response at 6 months was the primary endpoint. The DEB-TACE treatment was administered at baseline, and again at months 2 and 4. Overall, the 6-month tumour response rate was not significantly different between the 2 arms (63% DEB-TACE vs 52% c-TACE). Among patients with the most advanced disease (Child-Pugh A or ECOG-1), however, response rates were 63% for those receiving DEB-TACE and 32% for those receiving c-TACE. In this group of patients, the DEB-TACE arm showed a statistically significant advantage in both disease control (P = .026) and objective response (P = .038) for a combined advantage of P < .05. Median time to progression was not achieved in the DEB-TACE arm even after 270 days, whereas patients in the c-TACE arm reached a median time to progression of 228 days. There were more drug-related adverse events per 100 treatments in the c-TACE arm versus DEB-TACE (79/100 vs 58/100). Grade 3 and 4 adverse events were also more common among patients receiving c-TACE. Complications affecting the liver and gastrointestinal tract were more frequent in patients who received c-TACE, but complications of the gallbladder and pancreas occurred more frequently among patients who received DEB-TACE. This finding, Dr. Malagari said, was attributable to "inadvertent embolisation." Dr. Malagari noted that there were some limitations to this study; in particular, the response rate seen with c-TACE was considerably higher than what has been seen in other studies. This trial, therefore, probably was not powered to determine superiority of DEB-TACE over c-TACE. Dr. Malagari added, however, that DEB-TACE did produce superior objective response and disease control among the more advanced patients, and there was a highly significant advantage in terms of doxorubicin-related side effects. The lower rate of adverse events and serious adverse events should make patients more amenable to treatment, Dr. Malagari concluded, and would be expected to improve their quality of life while they are undergoing treatment as well.
[Presentation title: A Randomised Phase II Trial of a Drug Eluting Bead in the Treatment of Hepatocellular Carcinoma by Transcatheter Arterial Chemoembolization.]
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