Informace o publikaci

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

Autoři	ROELLIG Christoph STEFFEN Bjoern SCHLIEMANN Christoph MIKESCH Jan-Henrik ALAKEL Nael HERBST Regina HAENEL Mathias NOPPENEY Richard HANOUN Maher KAUFMANN Martin WEINBERGEROVÁ Barbora SCHAEFER-ECKART Kerstin SAUER Tim NEUBAUER Andreas BURCHERT Andreas BALDUS Claudia D MERTOVA Jolana JOST Edgar NIEMANN Dirk NOVAK Jan KRAUSE Stefan W SCHOLL Sebastian HOCHHAUS Andreas HELD Gerhard SZOTKOWSKI Tomas RANK Andreas SCHMID Christoph FRANSECKY Lars KAYSER Sabine SCHAICH Markus KRAMER Michael FIEBIG Frank HAAKE Annett SCHETELIG Johannes MIDDEKE Jan Moritz STOELZEL Friedrich PLATZBECKER Uwe THIEDE Christian MUELLER-TIDOW Carsten BERDEL Wolfgang E EHNINGER Gerhard MAYER Jiří SERVE Hubert BORNHAEUSER Martin
Rok publikování	2025
Druh	Článek v odborném periodiku
Časopis / Zdroj	Journal of clinical oncology
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	https://ascopubs.org/doi/10.1200/JCO.24.00235
Doi	http://dx.doi.org/10.1200/JCO.24.00235
Popis	PURPOSETo 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 METHODSPatients 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.RESULTSEight 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).CONCLUSIONThe 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.