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Higher-Dose Daunorubicin No More Effective Than Lower Doses in AML

December 30, 2021

Escalating daunorubicin doses from 60 mg/m2 to 90 mg/m2 in a 7+3 induction regimen consisting of daunorubicin and cytarabine did not increase response rates in patients with newly diagnosed acute myeloid leukemia (AML), according to initial results from a randomized trial presented at the 23rd Congress of the European Hematology Association.

"The results of the DaunoDouble trial are the first to confirm that, in a standard 7+3 setting, daunorubicin 60 mg is equally effective as 90 mg in all subgroups," study author and presenter Christoph Röllig, MD, of the University Hospital Dresden in Germany, told ASH Clinical News.

DaunoDouble included 314 patients (median age = 48 years; range not provided) with newly diagnosed AML, normal cardiac and organ function, and no prior history of anthracycline treatment. The following baseline characteristics were noted:

  • de novo AML (87%)
  • NPM1 mutation (41%)
  • FLT3-ITD mutation (20%)
  • CEBPA double mutation (5%)

Most patients had intermediate-risk disease (73%; per European Leukemia-Net criteria).

Study investigators randomized participants to the following arms:

  • Dauno90: cytarabine 100 mg/m2 for 7 days plus daunorubicin 90 mg/m2 on days 3-5 (n=157)
  • Dauno60: cytarabine 100 mg/m2 for 7 days plus daunorubicin 60 mg/m2 on days 3-5 (n=157)

Bone marrow response was assessed at 15 days following initiation of chemotherapy. A "good" treatment response was defined as a blast count <5 percent.

There was no statistically significant difference in response rates between the Dauno90 and Dauno60 groups: 47.8% (95% CI 39.7-55.9) vs. 42.7% (95% CI 34.8-50.8; p=0.29).

"The tolerability was similar in both dose levels with no obvious signs of excess toxicity," the authors noted, with similar proportions of patients in each group experiencing adverse events (AEs): 89.8% in the 90 mg/m2 group and 86.6% in the 60 mg/m2.

A higher proportion of patients experienced grade ≥3 AEs in the 90 mg/m2 group than the 60 mg/m2 group (20.3% vs. 16.2%). Similarly, a slightly higher proportion in the former group experienced early mortality within 14 days following induction (1.3% vs. 0.6%), as well as at 28 days of treatment (3.2% vs. 1.3%; p=0.251).

"Apart from early response, we will now have to look at other relevant clinical outcomes of the trial, such as comparison of complete response rates, relapse-free survival, and overall survival, between the two treatment arms," Dr. Röllig explained. "These findings need longer follow-up to be confirmed, but we hope to be able to show more mature results later this year." Participants who achieved a good response in this study became eligible for a subsequent, ongoing randomized study, which is evaluating a second 7+3 induction.

In addition to the short follow-up, the study has not yet assessed more clinically meaningful endpoints, such as overall survival.


Röllig C, Steffen B, Herbst R, et al. Randomized comparison of 90 mg versus 60 mg daunorubicin in 7+3 standard induction for newly diagnosed acute myeloid leukemia: results from the SAL-DaunoDouble trial. Abstract #S861. Presented at the 23rd Congress of the European Hematology Association, June 16, 2018; Stockholm, Sweden.


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