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Randomized Controlled Trial
. 2025 Jan;43(1):65-74.
doi: 10.1200/JCO.24.00235. Epub 2024 Sep 16.

Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia

Christoph Röllig  1 , Björn Steffen  2 , Christoph Schliemann  3 , Jan-Henrik Mikesch  3 , Nael Alakel  1 , Regina Herbst  4 , Mathias Hänel  4 , Richard Noppeney  5 , Maher Hanoun  5 , Martin Kaufmann  6 , Barbora Weinbergerova  7 , Kerstin Schäfer-Eckart  8 , Tim Sauer  9 , Andreas Neubauer  10 , Andreas Burchert  10 , Claudia D Baldus  11 , Jolana Mertová  12 , Edgar Jost  13 , Dirk Niemann  14 , Jan Novák  15 , Stefan W Krause  16 , Sebastian Scholl  17 , Andreas Hochhaus  17 , Gerhard Held  18 , Tomas Szotkowski  19 , Andreas Rank  20 , Christoph Schmid  20 , Lars Fransecky  11 , Sabine Kayser  21   22   23 , Markus Schaich  24 , Michael Kramer  1 , Frank Fiebig  1 , Annett Haake  1 , Johannes Schetelig  1 , Jan Moritz Middeke  1 , Friedrich Stölzel  11 , Uwe Platzbecker  21 , Christian Thiede  1   25 , Carsten Müller-Tidow  9 , Wolfgang E Berdel  3 , Gerhard Ehninger  1 , Jiri Mayer  7 , Hubert Serve  2 , Martin Bornhäuser  1
Affiliations
Randomized Controlled Trial

Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia

Christoph Röllig et al. J Clin Oncol. 2025 Jan.

Abstract

Purpose: To determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m2 with 90 mg/m2 daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.

Patients and methods: Patients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m2 daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.

Results: Eight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m2, all consecutive patients received 60 mg/m2 daunorubicin once daily. The proportion of good early responders was 44% versus 48% (P = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (P = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m2 once daily was 54% versus 50% (P = .561), and the 3-year overall survival (OS) was 65% versus 58% (P = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; P = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; P = .937).

Conclusion: The use of 90 mg/m2 daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m2 once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.

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