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| 001 | 143062 | ||
| 005 | 20240229112541.0 | ||
| 024 | 7 | _ | |a 10.1182/blood-2018-08-869453 |2 doi |
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| 100 | 1 | _ | |a Schlenk, Richard |0 P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc |b 0 |
| 245 | _ | _ | |a Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD. |
| 260 | _ | _ | |a Stanford, Calif. |c 2019 |b HighWire Press |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 520 | _ | _ | |a Patients with acute myeloid leukemia (AML) and a FLT3 internal tandem duplication (ITD) have poor outcomes to current treatment. A phase 2 hypothesis-generating trial was conducted to determine whether the addition of the multitargeted kinase inhibitor midostaurin to intensive chemotherapy followed by allogeneic hematopoietic cell transplantation (alloHCT) and single-agent maintenance therapy of 12 months is feasible and favorably influences event-free survival (EFS) compared with historical controls. Patients 18 to 70 years of age with newly diagnosed AML and centrally confirmed FLT3-ITD were eligible: 284 patients were treated, including 198 younger (18-60 years) and 86 older (61-70 years) patients. Complete remission (CR) rate, including CR with incomplete hematological recovery (CRi) after induction therapy, was 76.4% (younger, 75.8%; older, 77.9%). The majority of patients in CR/CRi proceeded to alloHCT (72.4%). Maintenance therapy was started in 97 patients (34%): 75 after alloHCT and 22 after consolidation with high-dose cytarabine (HiDAC). Median time receiving maintenance therapy was 9 months after alloHCT and 10.5 months after HiDAC; premature termination was mainly a result of nonrelapse causes (gastrointestinal toxicity and infections). EFS and overall survival at 2 years were 39% (95% confidence interval [CI], 33%-47%) and 34% (95% CI, 24%-47%) and 53% (95% CI, 46%-61%) and 46% (95% CI, 35%-59%) in younger and older patients, respectively. EFS was evaluated in comparison with 415 historical controls treated within 5 prospective trials. Propensity score-weighted analysis revealed a significant improvement of EFS by midostaurin (hazard ratio [HR], 0.58; 95% CI, 0.48-0.70; P < .001) overall and in older patients (HR, 0.42; 95% CI, 0.29-0.61). The study was registered at www.clinicaltrials.gov as #NCT01477606. |
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| 700 | 1 | _ | |a Weber, Daniela |b 1 |
| 700 | 1 | _ | |a Fiedler, Walter |b 2 |
| 700 | 1 | _ | |a Salih, Helmut R |b 3 |
| 700 | 1 | _ | |a Wulf, Gerald |b 4 |
| 700 | 1 | _ | |a Salwender, Hans |b 5 |
| 700 | 1 | _ | |a Schroeder, Thomas |b 6 |
| 700 | 1 | _ | |a Kindler, Thomas |b 7 |
| 700 | 1 | _ | |a Lübbert, Michael |b 8 |
| 700 | 1 | _ | |a Wolf, Dominik |b 9 |
| 700 | 1 | _ | |a Westermann, Jörg |b 10 |
| 700 | 1 | _ | |a Kraemer, Doris |b 11 |
| 700 | 1 | _ | |a Götze, Katharina S |0 0000-0002-6276-8002 |b 12 |
| 700 | 1 | _ | |a Horst, Heinz-August |b 13 |
| 700 | 1 | _ | |a Krauter, Jürgen |b 14 |
| 700 | 1 | _ | |a Girschikofsky, Michael |b 15 |
| 700 | 1 | _ | |a Ringhoffer, Mark |b 16 |
| 700 | 1 | _ | |a Südhoff, Thomas |b 17 |
| 700 | 1 | _ | |a Held, Gerhard |b 18 |
| 700 | 1 | _ | |a Derigs, Hans-Günter |b 19 |
| 700 | 1 | _ | |a Schroers, Roland |b 20 |
| 700 | 1 | _ | |a Greil, Richard |b 21 |
| 700 | 1 | _ | |a Grießhammer, Martin |b 22 |
| 700 | 1 | _ | |a Lange, Elisabeth |b 23 |
| 700 | 1 | _ | |a Burchardt, Alexander |b 24 |
| 700 | 1 | _ | |a Martens, Uwe |b 25 |
| 700 | 1 | _ | |a Hertenstein, Bernd |b 26 |
| 700 | 1 | _ | |a Marretta, Lore |b 27 |
| 700 | 1 | _ | |a Heuser, Michael |b 28 |
| 700 | 1 | _ | |a Thol, Felicitas |b 29 |
| 700 | 1 | _ | |a Gaidzik, Verena I |b 30 |
| 700 | 1 | _ | |a Herr, Wolfgang |b 31 |
| 700 | 1 | _ | |a Krzykalla, Julia |0 P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9 |b 32 |
| 700 | 1 | _ | |a Benner, Axel |0 P:(DE-He78)e15dfa1260625c69d6690a197392a994 |b 33 |
| 700 | 1 | _ | |a Döhner, Konstanze |b 34 |
| 700 | 1 | _ | |a Ganser, Arnold |b 35 |
| 700 | 1 | _ | |a Paschka, Peter |b 36 |
| 700 | 1 | _ | |a Döhner, Hartmut |b 37 |
| 700 | 1 | _ | |a Group, German-Austrian AML Study |b 38 |e Collaboration Author |
| 773 | _ | _ | |a 10.1182/blood-2018-08-869453 |g Vol. 133, no. 8, p. 840 - 851 |0 PERI:(DE-600)1468538-3 |n 8 |p 840 - 851 |t Blood |v 133 |y 2019 |x 0006-4971 |
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