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

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

Research output: Contribution to journalArticle

180 Scopus citations

Abstract

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).

Original languageEnglish (US)
Pages (from-to)2061-2068
Number of pages8
JournalLeukemia
Volume26
Issue number9
DOIs
StatePublished - Sep 2012

Keywords

  • FMS-like tyrosine kinase 3 receptor
  • PKC412
  • acute myeloid leukemia
  • midostaurin
  • newly diagnosed

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Stone, R. M., Fischer, T., Paquette, R., Schiller, G., Schiffer, C. A., Ehninger, G., Cortes, J., Kantarjian, H. M., Deangelo, D. J., Huntsman-Labed, A., Dutreix, C., Del Corral, A., & Giles, F. (2012). Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia. Leukemia, 26(9), 2061-2068. https://doi.org/10.1038/leu.2012.115