High-dose daunorubicin benefits younger adults with leukemia
(11 October 2009: VIDYYA MEDICAL NEWS SERVICE) -- In two studies published in the September 24 New England Journal of Medicine, a high dose of daunorubicin given as part of initial treatment for acute myeloid leukemia (AML) increased the rate of complete remission and, in one study, improved overall survival compared with the standard dose given in the clinic. These beneficial effects of high-dose daunorubicin appeared to be confined to patients aged 65 or younger.
One clinical trial, designed by the Eastern Cooperative Oncology Group, randomly assigned 657 patients aged 17 to 60 to either high-dose or standard-dose daunorubicin; all patients also received the drug cytarabine. If a complete remission was not observed after the first course of the drugs, patients received a second course of cytarabine and standard-dose daunorubicin.
Significantly more patients in the high-dose daunorubicin group had a complete remission compared with those in the standard-dose group (70.6 percent versus 57.3 percent). The median overall survival was 15.7 months for patients in the standard-dose group and 23.7 months for patients in the high-dose group.
The second trial, performed by several European cooperative research groups, enrolled 813 patients between ages 60 and 83. Patients were randomly assigned to receive a first course of either standard-dose or high-dose daunorubicin, along with cytarabine. All patients received a second cycle of treatment with cytarabine alone.
Significantly more patients in the high-dose daunorubicin group had a complete remission (64 percent versus 54 percent in the standard-dose group). However, unlike in the American study, the two groups did not have significant differences in survival. An analysis showed that patients aged 60 to 65 had an increase in survival with high-dose daunorubicin; however, explained the authors, “these differences could be due to chance findings,” since the trial was not designed to analyze the results by age group.
Neither trial saw an increase in serious side effects from the higher dose of daunorubicin. “The lack of an increase in toxic effects and the benefit in overall survival strongly argue for incorporating high-dose daunorubicin into the initial treatment of younger patients with AML,” concluded the authors of an accompanying editorial.
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