Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia

被引：0
作者：
R M Stone
T Fischer
R Paquette
G Schiller
C A Schiffer
G Ehninger
J Cortes
H M Kantarjian
D J DeAngelo
A Huntsman-Labed
C Dutreix
A del Corral
F Giles
机构：
[1] Medical Oncology,Department of Hematology/Oncology
[2] Dana-Farber Cancer Institute,undefined
[3] Medical Center,undefined
[4] Otto-von-Guericke-University,undefined
[5] UCLA Medical Center,undefined
[6] Karmanos Cancer Institute,undefined
[7] Technische Universität,undefined
[8] MD Anderson Cancer Center,undefined
[9] Novartis Pharma AG,undefined
[10] Novartis Oncology,undefined
[11] HRB Clinical Research Facility,undefined
[12] National University of Ireland,undefined
[13] Galway and Trinity College,undefined
来源：
Leukemia | 2012年 / 26卷
关键词：
FMS-like tyrosine kinase 3 receptor; acute myeloid leukemia; midostaurin; PKC412; newly diagnosed;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
This phase 1b trial investigated several doses and schedules of midostaurin in combination with daunorubicin and cytarabine induction and high-dose cytarabine post-remission therapy in newly diagnosed patients with acute myeloid leukemia (AML). The discontinuation rate on the 50-mg twice-daily dose schedule was lower than 100 mg twice daily, and no grade 3/4 nausea or vomiting was seen. The complete remission rate for the midostaurin 50-mg twice-daily dose schedule was 80% (FMS-like tyrosine kinase 3 receptor (FLT3)–wild-type: 20 of 27 (74%), FLT3-mutant: 12 of 13 (92%)). Overall survival (OS) probabilities of patients with FLT3-mutant AML at 1 and 2 years (0.85 and 0.62, respectively) were similar to the FLT3–wild-type population (0.78 and 0.52, respectively). Midostaurin in combination with standard chemotherapy demonstrated high complete response and OS rates in newly diagnosed younger adults with AML, and was generally well tolerated at 50 mg twice daily for 14 days. A phase III prospective trial is ongoing (CALGB 10603, NCT00651261).
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页码：2061 / 2068
页数：7
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