NEW YORK (Reuters Health) Jan 06 - A substantial minority of older patients with acute myeloid leukemia (AML) responds to first-line treatment with the nucleoside analogue decitabine, researchers report in a December 21st on-line paper in the Journal of Clinical Oncology.
"In this Phase II study, the complete response rate of 24% was observed even in patients with high-risk disease features, like poor-risk cytogenetics and preceding myelodysplastic syndrome," lead author Dr. Amanda F. Cashen told Reuters Health by email.
"These encouraging findings justify investigation of this relatively well-tolerated therapy in larger, randomized studies in elderly AML patients," she added.
Dr. Cashen of Washington University School of Medicine, St. Louis, and her colleagues treated 55 treatment-na�ve AML patients, all at least 60 years old, with decitabine 20 mg/m2 intravenously for 5 consecutive days of a 4-week cycle. Study participants completed a median of 3 cycles.
The overall response rate was 25% and the complete response rate was 24%. Overall median survival was 7.7 months, and the 30-day mortality rate was 7%.
All patients had myelosuppression, 29% had febrile neutropenia, and 26% had fatigue. Twenty-six patients (47.3%) experienced at least one serious adverse event that appeared to be related to treatment.
Even so, the investigators considered the results to be promising, and treatment-related toxicity and mortality to be relatively low.
In an editorial, Dr. Charles A. Schiffer of Wayne State University School of Medicine, Detroit, comments on these and other data on AML therapy in the elderly.
Despite the age of these patients, he says, "the instinct should be to treat -- with the goal of achieving remission and/or improvement of blood counts -- rather than to search for reasons why treatment should not be given."
J Clin Oncol 2009.
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