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Table 1 Characteristics of included studies

From: FLT3 inhibitors in acute myeloid leukaemia: assessment of clinical effectiveness, adverse events and future research—a systematic review and meta-analysis

Author, year
Trial name/number 		Population selection criteria Intervention N randomised and details Control N randomised and details Intervention baseline age (yrs) and type of AML Control baseline age (yrs) and type of AML Outcomes reported and median follow-up
Rollig C, 2015 [15]
SORAML; NCT00893373;
Phase 2, Germany 		Aged 18–60 yrs, newly diagnosed de novo or secondary AML
(excluding APL) 		Sorafenib 400 mg twice daily plus standard chemo—ind/cons/main up to 12 mths
N = 138a 		Placebo plus standard chemo
N = 138a 		Median age (range):
50 (43–46);
de novo AML: NR;
2° AML: 10%;
High-risk MDS: NR 		Median age (range):
50 (44–55);
de novo AML: NR;
2° AML: 15%;
High-risk MDS: NR 		1°: EFS
2°: RFS, OS, CR, tox
FU: 36 mths
Serve H, 2013 [16]
NCT00373373;
Phase 2, Germany 		Aged > 60 yrs, de novo or secondary AML or AML from MDS
(excluding FAB type M3) 		Sorafenib 400 mg twice daily plus intensive chemo—ind/cons
N = 104a 		Placebo plus intensive chemo
N = 97a 		Median age (range): 67.5 (61–78);
de novo AML: 60%;
2° AML: 40%;
High-risk MDS: NR 		Median age (range):
69 (61–80);
de novo AML: 61%;
2° AML: 39%;
High-risk MDS: NR 		1°: EFS
2°: OS, CR rate, tolerability
FU: 29.3 mths
Knapper S, 2017 [17]
AML15; ISRCTN17161961;
Phase 3, UK Denmark, NZ 		Aged < 60 yrs, de novo or secondary AML, FLT3 mutation
(excluding APL) 		Lestaurtinib 80 mg, twice daily after each of 4 courses of intensive chemo—ind/cons
N = 88 		Intensive chemo
N = 87 		Median age (range):
48 (16–66);
de novo AML: 95%;
2° AML: 3%;
High-risk MDS: 0% 		Median age (range):
46 (16-65);
de novo AML: 97%;
2° AML: 5%;
High-risk MDS: 0% 		1°: OS/RFS
2°: CR, CRi, OS, haem recovery times, tox, resource use
FU: 50.5 mths
Knapper S, 2017 [17]
AML17; ISRCTN55675535
Phase 3, UK Denmark, NZ 		Aged < 60 yrs, de novo or secondary AML, FLT3 mutation
(excluding APL) 		Lestaurtinib 80 mg, twice daily plus 1st line intensive chemo—ind/cons
N = 212 		Placebo plus 1st line intensive chemo
N = 113 		Median age (range):
50 (5–68);
de novo AML: 93%;
2° AML: 5%;
High-risk MDS: 2% 		Median age (range):
50 (6–65);
de novo AML: 92%;
2° AML: 5%;
High-risk MDS: 3% 		1°: OS/RFS
2°: CR, CRi, OS, haem recovery times, tox, resource use
FU: 50.5 mths
Levis M, 2011 [18]
Cephalon-204; NCT00079482;
Phase 2, Australia, Canada, EU, Israel, NZ, Russia, Ukraine, USA 		Aged ≥ 18 yrs, AML with 1st relapse after 1st remission of 1–24 mths, FLT3 mutation Salvage chemo followed by lestaurtinib 80 mg, twice daily
N = 112 		Salvage chemo
N = 112 		Median age (range):
59 (20–81);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		Median age (range):
54 (21–79);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		1°: CR, CRp
2°: OS, PR, tox, tolerability
FU: not reported
Stone RM, 2017 [19]
RATIFY calgb 10603; NCT00651261;
Phase 3, Canada, USA 		Aged 18–59 yrs, newly diagnosed AML, FLT3 mutation
(excluding APL) 		Midostaurin 50 mg twice daily plus standard chemo—ind/cons/main up to 12 mths
N = 360 		Placebo 50 mg twice daily plus standard chemo
N = 357 		Median age (range):
47.1 (19–60);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		Median age (range):
48.6 (18–61);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		1°: OS
2°: EFS, OS, CR rate, DFS, HCT rate
FU: 59 mths
Perl AE, 2019 [21]
ADMIRAL;
NCT02421939;
Phase 3, 14 countries 		Aged > 18 yrs, relapsed or refractory AML, FLT3 mutation Gilteritinib 120 mg, once daily in 28-day cycles
N = 247 		Salvage chemo
N = 124 		Median age (range):
62.0 (20.0–84.0);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		Median age (range):
61.5 (19.0–85.0);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		1°: OS, CR
2°: EFS, tox
FU: 17.8 mths
Cortes JE, 2019 [20]
QuANTUM-R; NCT02039726;
Phase 3, 19 countries 		Aged > 18 yrs, relapsed or refractory AML, FLT3-ITD mutation
(excluding APL) 		Quizartinib 20–60 mg as appropriate, once daily in continuous 28-day cycles
N = 245 		Salvage chemo
N = 122 		Median age (range):
55.0 (46.0–65.0);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		Median age (range):
57.5 (44.0–66.0);
de novo AML: NR;
2° AML: NR;
High-risk MDS: NR 		1°: OS
2°: EFS, CR, early death (30- and 60-day mortality)
FU: 23.5 mths
  1. Abbreviations: AML acute myeloid leukaemia, APL acute promyelocytic leukaemia, chemo chemotherapy, cons consolidation therapy, CR complete remission, CRi CR with incomplete haematologic recovery, CRp CR with incomplete platelet recovery, DFS disease-free survival, EFS event-free survival, FAB French-American British (classification system), FLT3 fms-like tyrosine kinase 3, FU follow-up, HCT haematopoietic cell transplant, ind induction therapy, main maintenance therapy, MDS myelodysplastic syndrome, mths months, NR not reported, NZ New Zealand, OS overall survival, PR partial remission, RFS relapse-free survival, tox toxicity, yrs years, 1° primary, 2° secondary
  2. aN includes patients who were randomised and untreated and/or not included in the individual trial analyses
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Systematic Reviews

ISSN: 2046-4053