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Drug-Eluting Beads Fight Liver Cancer: Presented at ISET

By Michael Casasnovas

HOLLYWOOD, FL -- February 6, 2007 -- In a pilot study, 90% of patients with liver cancer infused with drug-eluting beads were alive more than 1 year later, researchers reported here at the 19^th International Symposium on Endovascular Therapy (ISET).

The beads were placed into tiny arteries that fed the cancer in a procedure known as transarterial chemoembolization of hepatocellular carcinoma with doxorubicin-loaded microspheres.

"The potential benefit of hepatocellular carcinoma chemoembolization can be limited by the passage of the chemotherapeutic agent into the systemic circulation," said Johannes Lammer, MD, professor of radiology, University Hospital, Vienna, Austria.

Dr. Lammer noted, the experimental treatment did not appear to cause major systemic adverse events.

The 6-month efficacy, an objective tumor response of 44% to 56%, favorably compares with the published literature, he said.

"The drug-eluting bead is a novel agent for chemoembolisation with a unique availability for loading doxorubicin. A slow release of doxorubicin has significant potential benefits," Dr. Lammer said in his oral presentation on February 1^st.

His study enrolled 30 patients, ages 44 to 82 years, all of whom were diagnosed with hepatocellular carcinoma. Patients were included in the trial if they had some preserved liver function yet were not candidates for resection, transplantation or percutaneous therapies. Patients also had to have a Karnofsky performance status score greater than 60; were expected to live more than 3 months, and were able to give informed consent.

Treatment was administered at baseline and then at months 2 and 4. Patients underwent follow-up visits at 1, 3 and 6 months for evaluation of clinical status and for laboratory liver and blood tests.

Among the 25 patients who were treated, 3 achieved a complete response using Response Evaluated Criteria in Solid Tumors (RECIST). Another 7 patients achieved a partial response and 5 achieved disease stabilization.

Three patients died, including 1 of the patients who had achieved complete response at 6-month. That patient died from cholecystitis.

Mean survival at the time of Dr. Lammer's presentation was 376 days, ranging from 334 days to 419 days.

He said that 15 European centers in 5 countries are now enrolling 200 patients in "The Prospective Randomized Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (Precision V Study)."


[Presentation title: Chemoembolization of HCC With Drug eluting Beads.]

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