Vorinostat Promising in AML

NEW YORK MAR 18, 2008 (Reuters Health) - An open-label phase I study of vorinostat (suberoylanilide hydroxamic acid) suggests that the drug has beneficial effects in some patients with leukemias and related conditions.

"The data indicate," lead investigator Dr. Guillermo Garcia-Manero told Reuters Health, "that this class of agents, the histone deacetylase inhibitors, may have activity in leukemia and myelodysplastic syndrome."

In the February 1st issue of Blood, Dr. Garcia-Manero of the University of Texas MD Anderson Cancer Center, Houston and colleagues report that they studied 41 patients, 31 of whom had acute myeloid leukemia (AML). The remaining patients had other leukemias or myelodysplastic syndrome.

All of the patients had relapsed, had refractory disease or were not candidates for chemotherapy. The subjects were given from 100 to 300 mg of vorinostat two or three times daily for 14 days, followed by 1 week of rest.

The maximum tolerated dose was 250 mg three times daily. Five patients (12%) had adverse experiences that required dose reduction.

Among the common adverse events were mild-to-moderate anorexia and nausea. Grade 3/4 adverse events related to the drug included fatigue, thrombocytopenia and diarrhea. Twenty-nine patients dropped out of the study because of disease progression.

The seven patients (17%) who had a complete response, a complete response with incomplete blood count, or hematologic improvements all had AML. All of these patients received vorinostat doses at or below the recommended level. No bona fide responses were seen in the patients without AML.

Given these findings, the researchers conclude that further evaluation of vorinostat in leukemia patients is warranted.

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