-
Something wrong with this record ?
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
C. Röllig, B. Steffen, C. Schliemann, JH. Mikesch, N. Alakel, R. Herbst, M. Hänel, R. Noppeney, M. Hanoun, M. Kaufmann, B. Weinbergerova, K. Schäfer-Eckart, T. Sauer, A. Neubauer, A. Burchert, CD. Baldus, J. Mertová, E. Jost, D. Niemann, J....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Multicenter Study
PubMed
39284116
DOI
10.1200/jco.24.00235
Knihovny.cz E-resources
- MeSH
- Leukemia, Myeloid, Acute * drug therapy mortality MeSH
- Cytarabine * administration & dosage MeSH
- Daunorubicin * administration & dosage MeSH
- Adult MeSH
- Remission Induction MeSH
- Induction Chemotherapy * methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Antibiotics, Antineoplastic administration & dosage MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use administration & dosage MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
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.
2 Medizinische Klinik Universitätsklinikum Augsburg Augsburg Germany
Department of Hemato Oncology Palacký University Olomouc Czech Republic
Department of Hematology Oncology and Palliative Care Rems Murr Kliniken Winnenden Germany
Department of Hematology Robert Bosch Krankenhaus Stuttgart Germany
Department of Hematology University Hospital Essen University of Duisburg Essen Essen Germany
Department of Internal Medicine 1 University Hospital TU Dresden Dresden Germany
Department of Internal Medicine 2 University Hospital Frankfurt Frankfurt Germany
Department of Internal Medicine 3 Chemnitz Hospital Chemnitz Germany
Department of Internal Medicine 5 Universitätsklinikum Erlangen Erlangen Germany
Department of Internal Medicine 5 University of Heidelberg Heidelberg Germany
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Department of Medicine A University Hospital Münster Münster Germany
Institute of Hematology and Blood Transfusion Prague Czech Republic
Klinik für Innere Medizin 1 Westpfalzklinikum Kaiserslautern Germany
Klinik für Innere Medizin Universitätsklinikum Jena Jena Germany
NCT Trial Center National Center of Tumor Diseases German Cancer Research Center Heidelberg Germany
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25002927
- 003
- CZ-PrNML
- 005
- 20250206103944.0
- 007
- ta
- 008
- 250121s2025 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1200/JCO.24.00235 $2 doi
- 035 __
- $a (PubMed)39284116
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Röllig, Christoph $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $1 https://orcid.org/0000000237910548
- 245 10
- $a 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 / $c C. Röllig, B. Steffen, C. Schliemann, JH. Mikesch, N. Alakel, R. Herbst, M. Hänel, R. Noppeney, M. Hanoun, M. Kaufmann, B. Weinbergerova, K. Schäfer-Eckart, T. Sauer, A. Neubauer, A. Burchert, CD. Baldus, J. Mertová, E. Jost, D. Niemann, J. Novák, SW. Krause, S. Scholl, A. Hochhaus, G. Held, T. Szotkowski, A. Rank, C. Schmid, L. Fransecky, S. Kayser, M. Schaich, M. Kramer, F. Fiebig, A. Haake, J. Schetelig, JM. Middeke, F. Stölzel, U. Platzbecker, C. Thiede, C. Müller-Tidow, WE. Berdel, G. Ehninger, J. Mayer, H. Serve, M. Bornhäuser
- 520 9_
- $a 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.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a daunomycin $x aplikace a dávkování $7 D003630
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 12
- $a akutní myeloidní leukemie $x farmakoterapie $x mortalita $7 D015470
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a cytarabin $x aplikace a dávkování $7 D003561
- 650 12
- $a indukční chemoterapie $x metody $7 D060828
- 650 12
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $x aplikace a dávkování $7 D000971
- 650 _2
- $a mladý dospělý $7 D055815
- 650 _2
- $a indukce remise $7 D012074
- 650 _2
- $a mladiství $7 D000293
- 650 _2
- $a rozvrh dávkování léků $7 D004334
- 650 _2
- $a protinádorová antibiotika $x aplikace a dávkování $7 D000903
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Steffen, Björn $u Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany
- 700 1_
- $a Schliemann, Christoph $u Department of Medicine A, University Hospital Münster, Münster, Germany $1 https://orcid.org/0000000317559583
- 700 1_
- $a Mikesch, Jan-Henrik $u Department of Medicine A, University Hospital Münster, Münster, Germany
- 700 1_
- $a Alakel, Nael $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $1 https://orcid.org/0000000336695564
- 700 1_
- $a Herbst, Regina $u Department of Internal Medicine III, Chemnitz Hospital, Chemnitz, Germany
- 700 1_
- $a Hänel, Mathias $u Department of Internal Medicine III, Chemnitz Hospital, Chemnitz, Germany
- 700 1_
- $a Noppeney, Richard $u Department of Hematology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
- 700 1_
- $a Hanoun, Maher $u Department of Hematology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
- 700 1_
- $a Kaufmann, Martin $u Department of Hematology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
- 700 1_
- $a Weinbergerova, Barbora $u Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic $1 https://orcid.org/0000000164602471
- 700 1_
- $a Schäfer-Eckart, Kerstin $u Department of Internal Medicine V, Nuremberg Hospital North, Paracelsus Medical University, Nuremberg, Germany
- 700 1_
- $a Sauer, Tim $u Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany $1 https://orcid.org/000000015412324X
- 700 1_
- $a Neubauer, Andreas $u Department of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Marburg, Marburg, Germany $1 https://orcid.org/0000000276068760
- 700 1_
- $a Burchert, Andreas $u Department of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Marburg, Marburg, Germany $1 https://orcid.org/0000000284118844
- 700 1_
- $a Baldus, Claudia D $u Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 700 1_
- $a Mertová, Jolana $u Institute of Hematology and Blood Transfusion, Prague, Czech Republic
- 700 1_
- $a Jost, Edgar $u Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, University Hospital Aachen & CIO ABCD Aachen, RWTH Aachen, Aachen, Germany
- 700 1_
- $a Niemann, Dirk $u Department of Hematology, Oncology and Palliative Care, Gemeinschaftsklinikum Mittelrhein, Koblenz, Germany
- 700 1_
- $a Novák, Jan $u Department of Haematology, 3rd Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Hràdec Kralovè, Czech Republic
- 700 1_
- $a Krause, Stefan W $u Department of Internal Medicine V, Universitätsklinikum Erlangen, Erlangen, Germany $1 https://orcid.org/0000000252594651
- 700 1_
- $a Scholl, Sebastian $u Klinik für Innere Medizin, Universitätsklinikum Jena, Jena, Germany
- 700 1_
- $a Hochhaus, Andreas $u Klinik für Innere Medizin, Universitätsklinikum Jena, Jena, Germany $1 https://orcid.org/0000000306260834
- 700 1_
- $a Held, Gerhard $u Klinik für Innere Medizin 1, Westpfalzklinikum, Kaiserslautern, Germany
- 700 1_
- $a Szotkowski, Tomas $u Department of Hemato-Oncology, Palacký University, Olomouc, Czech Republic $1 https://orcid.org/0000000213367093 $7 xx0060568
- 700 1_
- $a Rank, Andreas $u II. Medizinische Klinik, Universitätsklinikum Augsburg, Augsburg, Germany
- 700 1_
- $a Schmid, Christoph $u II. Medizinische Klinik, Universitätsklinikum Augsburg, Augsburg, Germany $1 https://orcid.org/000000017070487X
- 700 1_
- $a Fransecky, Lars $u Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany $1 https://orcid.org/0000000236580284
- 700 1_
- $a Kayser, Sabine $u Department of Internal Medicine I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany $u NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg, Germany $u Insitute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
- 700 1_
- $a Schaich, Markus $u Department of Hematology, Oncology and Palliative Care, Rems-Murr-Kliniken, Winnenden, Germany
- 700 1_
- $a Kramer, Michael $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany
- 700 1_
- $a Fiebig, Frank $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany
- 700 1_
- $a Haake, Annett $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany
- 700 1_
- $a Schetelig, Johannes $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $1 https://orcid.org/0000000227802981
- 700 1_
- $a Middeke, Jan Moritz $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $1 https://orcid.org/000000033250293X
- 700 1_
- $a Stölzel, Friedrich $u Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 700 1_
- $a Platzbecker, Uwe $u Department of Internal Medicine I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany $1 https://orcid.org/0000000318633239
- 700 1_
- $a Thiede, Christian $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $u Agendix GmbH, Dresden, Germany $1 https://orcid.org/0000000312412048
- 700 1_
- $a Müller-Tidow, Carsten $u Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany $1 https://orcid.org/0000000271665232
- 700 1_
- $a Berdel, Wolfgang E $u Department of Medicine A, University Hospital Münster, Münster, Germany $1 https://orcid.org/0000000230306567 $7 xx0263458
- 700 1_
- $a Ehninger, Gerhard $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany
- 700 1_
- $a Mayer, Jiri $u Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic $1 https://orcid.org/0000000305679887 $7 nlk20000083651
- 700 1_
- $a Serve, Hubert $u Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany $1 https://orcid.org/0000000184725516
- 700 1_
- $a Bornhäuser, Martin $u Department of Internal Medicine I, University Hospital TU Dresden, Dresden, Germany $1 https://orcid.org/0000000259163029
- 773 0_
- $w MED00002596 $t Journal of clinical oncology $x 1527-7755 $g Roč. 43, č. 1 (2025), s. 65-74
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39284116 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250121 $b ABA008
- 991 __
- $a 20250206103940 $b ABA008
- 999 __
- $a ok $b bmc $g 2262990 $s 1238934
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 43 $c 1 $d 65-74 $e 20240916 $i 1527-7755 $m Journal of clinical oncology $n J Clin Oncol $x MED00002596
- LZP __
- $a Pubmed-20250121
