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Midostaurin plus daunorubicin or idarubicin for young and older adults with FLT3 -mutated AML : a phase 3b trial
Sierra, Jorge (Institut d'Investigació Biomèdica Sant Pau)
Montesinos, Pau (Instituto de Salud Carlos III)
Thomas, Xavier (Hospices Civils de Lyon)
Griskevicius, Laimonas (Vilnius University Hospital Santariskiu Clinics)
Cluzeau, Thomas (Equipe Labellisée par la Ligue Nationale Contre le Cancer)
Caillot, Denis (Dijon University Hospital)
Legrand, Ollivier (Sorbonne University)
Minotti, Clara (Sapienza University of Rome)
Luppi, Mario (University of Modena and Reggio Emilia)
Farkas, Firas (University Hospital, Bratislava, Slovakia)
Bengoudifa, Bourras-Rezki (Novartis Pharmaceuticals AG)
Gilotti, Geralyn (Novartis Pharmaceuticals Corporation)
Hodzic, Sejla (Novartis Pharmaceuticals Corporation)
Rambaldi, Alessandro (Università degli Studi di Milano)
Venditti, Adriano (Tor Vergata University)
Universitat Autònoma de Barcelona

Data: 2023
Resum: The pivotal RATIFY study demonstrated midostaurin (50 mg twice daily) with standard chemotherapy significantly reduced mortality in adult patients (<60 years) with newly diagnosed (ND) FLT3 mut acute myeloid leukemia (AML). Considering that AML often present in older patients who show poor response to chemotherapy, this open-label, multicenter phase 3b trial was designed to further assess safety and efficacy of midostaurin plus chemotherapy in induction, consolidation, and maintenance monotherapy in young (≤60 years) and older (>60 years) patients with FLT3 mut ND-AML. Compared with RATIFY, this study extended midostaurin treatment from 14 days to 21 days, substituted anthracyclines (idarubicin or daunorubicin), and introduced variation in standard combination chemotherapy dosing ("7+3" or "5+2" in more fragile patients). Total 301 patients (47. 2% >60 years and 82. 7% with FLT3-ITD mut ) of median age 59 years entered induction phase. Overall, 295 patients (98. 0%) had at least 1 adverse event (AE), including 254 patients (84. 4%) with grade ≥3 AE. The grade ≥3 serious AEs occurred in 134 patients. No difference was seen in AE frequency between age groups, but grade ≥3AE frequency was higher in older patients. Overall, complete remission (CR) rate including incomplete hematologic recovery (CR + CRi) (80. 7% [95% confidence interval, 75. 74-84. 98]) was comparable between age groups (≤60 years [83. 5%]; >60 to ≤70 years [82. 5%]; in patients >70 years [64. 1%]) and the type of anthracycline used in induction. CR + CRi rate was lower in males (76. 4%) than females (84. 4%). Overall, the safety and efficacy of midostaurin remains consistent with previous findings, regardless of age, sex, or induction regimen. The trial is registered at as #.
Drets: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Llengua: Anglès
Document: Article ; recerca ; Versió publicada
Publicat a: Blood advances, Vol. 7 (august 2023) , p. 6441-6450, ISSN 2473-9537

DOI: 10.1182/bloodadvances.2023009847
PMID: 37581981


10 p, 660.6 KB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
Articles > Articles de recerca
Articles > Articles publicats

 Registre creat el 2024-04-24, darrera modificació el 2024-05-28



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