| Title |
Midostaurin plus daunorubicin or idarubicin for young and older adults with FLT3-mutated AML: a phase 3b trial / |
| Authors |
Sierra, Jorge ; Montesinos, Pau ; Thomas, Xavier ; Griškevičius, Laimonas ; Cluzeau, Thomas ; Caillot, Denis ; Legrand, Ollivier ; Minotti, Clara ; Luppi, Mario ; Farkas, Firas ; Bengoudifa, Bourras-Rezki ; Gilotti, Geralyn ; Hodzic, Sejla ; Rambaldi, Alessandro ; Venditti, Adriano |
| DOI |
10.1182/bloodadvances.2023009847 |
| Full Text |
|
| Is Part of |
Blood advances.. American Society of Hematology. 2023, vol. 7, iss. 21, p. 6441-6450.. ISSN 2473-9529. eISSN 2473-9537 |
| Abstract [eng] |
The pivotal RATIFY study demonstrated midostaurin (50 mg twice daily) with standard chemotherapy significantly reduced mortality in adult patients (60 years) patients with FLT3mut 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-ITDmut) 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. |
| Published |
American Society of Hematology |
| Type |
Journal article |
| Language |
English |
| Publication date |
2023 |
| CC license |
|
