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| 001 | 179738 | ||
| 005 | 20240229145552.0 | ||
| 024 | 7 | _ | |a 10.1182/bloodadvances.2022007223 |2 doi |
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| 100 | 1 | _ | |a Döhner, Hartmut |0 0000-0003-2116-5536 |b 0 |
| 245 | _ | _ | |a Midostaurin plus intensive chemotherapy for younger and older Patients with AML and FLT3 internal tandem duplications. |
| 260 | _ | _ | |a Washington, DC |c 2022 |b American Society of Hematology |
| 336 | 7 | _ | |a article |2 DRIVER |
| 336 | 7 | _ | |a Output Types/Journal article |2 DataCite |
| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1671007821_19579 |2 PUB:(DE-HGF) |
| 336 | 7 | _ | |a ARTICLE |2 BibTeX |
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| 336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
| 500 | _ | _ | |a 2022 Sep 27;6(18):5345-5355 |
| 520 | _ | _ | |a We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3 internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD. |
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| 700 | 1 | _ | |a Weber, Daniela |b 1 |
| 700 | 1 | _ | |a Krzykalla, Julia |0 P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9 |b 2 |
| 700 | 1 | _ | |a Fiedler, Walter |b 3 |
| 700 | 1 | _ | |a Wulf, Gerald Georg |b 4 |
| 700 | 1 | _ | |a Salih, Helmut R |b 5 |
| 700 | 1 | _ | |a Lübbert, Michael |b 6 |
| 700 | 1 | _ | |a Kühn, Michael |b 7 |
| 700 | 1 | _ | |a Schroeder, Thomas |b 8 |
| 700 | 1 | _ | |a Salwender, Hans |b 9 |
| 700 | 1 | _ | |a Götze, Katharina S |0 0000-0002-6276-8002 |b 10 |
| 700 | 1 | _ | |a Westermann, Jörg |b 11 |
| 700 | 1 | _ | |a Fransecky, Lars |0 0000-0002-3658-0284 |b 12 |
| 700 | 1 | _ | |a Mayer, Karin |b 13 |
| 700 | 1 | _ | |a Hertenstein, Bernd |b 14 |
| 700 | 1 | _ | |a Ringhoffer, Mark |b 15 |
| 700 | 1 | _ | |a Tischler, Hans-Joachim |b 16 |
| 700 | 1 | _ | |a Machherndl-Spandl, Sigrid |b 17 |
| 700 | 1 | _ | |a Schrade, Anika |b 18 |
| 700 | 1 | _ | |a Paschka, Peter |b 19 |
| 700 | 1 | _ | |a Gaidzik, Verena I |b 20 |
| 700 | 1 | _ | |a Theis, Frauke |b 21 |
| 700 | 1 | _ | |a Thol, Felicitas R |b 22 |
| 700 | 1 | _ | |a Heuser, Michael |b 23 |
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| 700 | 1 | _ | |a Bullinger, Lars |b 25 |
| 700 | 1 | _ | |a Saadati, Maral |b 26 |
| 700 | 1 | _ | |a Benner, Axel |0 P:(DE-He78)e15dfa1260625c69d6690a197392a994 |b 27 |
| 700 | 1 | _ | |a Larson, Richard A |0 0000-0001-9168-3203 |b 28 |
| 700 | 1 | _ | |a Stone, Richard M |b 29 |
| 700 | 1 | _ | |a Döhner, Konstanze |b 30 |
| 700 | 1 | _ | |a Ganser, Arnold |0 0000-0003-3510-4304 |b 31 |
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