Table 2 Comparison of available therapies for unfit patients with newly-diagnosed FLT3 mutated acute myeloid leukemia.
From: Newly diagnosed acute myeloid leukemia in unfit patients: 2026 treatment algorithms
Sorafenib + Azacitidine | Quizartinib + Azacitidine or Low-dose cytarabine | Quizartinib + Decitabine-Ven | Gilteritinib + Azacitidine vs. placebo + azacitidine | Gilteritinib + Azacitidine-Ven | Venetoclax (Ven) + Azacitidine vs. placebo + Azacitidine | |
---|---|---|---|---|---|---|
N | 27 | 34 | 26 | 74 vs. 49 | 30 | 42 vs. 22 |
FLT3 mutation | FLT3-ITD | FLT3-ITD | FLT3-ITD | FLT3-ITD + TKD | FLT3-ITD + TKD | FLT3-ITD + TKD |
Median age | 74 years | 72 years | 70 years | 78 vs. 76 years | 71 years | 75 vs. 75 years |
CR/CRi (CR) | 71% (26%) | 87% (53%) (Quiz-Aza) 74% (5%) (Quiz-LDAC) | 92% (69%) | 58% vs. 27% (16% vs. 14%) | 96% (90%) | 67% (38%) vs. 36% 63% (30%) vs. 46% (15%)(FLT3-ITD) 77% (54%) vs. 30% (20%) (FLT3-TKD) |
Median Overall survival | 8.3 months | 19.2 months (Quiz-Aza) 8.5 months (Quiz-LDAC) | Not reached | 9.8 vs. 8.9 months | Not reached | 9.9 months (FLT3-ITD) 19.2 months (FLT3-TKD) |
FLT3i adverse events | Grade 3 infections (26%) Diarrhea (22%) ↑ bilirubin (22%) Nausea (19%) | Grade 3 QTc prolongation (6%) | Pneumonia (38%) Neutropenic fever (57%) No grade 3 Qtc prolongation | Fever (48%) Diarrhea (38%) | ≥Grade 3 infection (53%) Febrile neutropenia (33%) Renal injury (7%) | ≥Grade 3 Febrile neutropenia (38%) ↓ platelets (38%) |
Reference | Ohanian et al., AJH 2018 | Swaminathan et al., Haematologica 2021 | Yilmaz et al., HemaSphere 2025 | Wang et al., Blood 2020 | Short et al., JCO 2024 | Konopleva et al., Clin Cancer Res 2022 |