A phase 2 study incorporating sorafenib into the chemotherapy for older adults with FLT3-mutated acute myeloid leukemia: CALGB 11001

Geoffrey L. Uy, Sumithra J. Mandrekar, Kristina Laumann, Guido Marcucci, Weiqiang Zhao, Mark J. Levis, Heidi D. Klepin, Maria R. Baer, Bayard L. Powell, Peter Westervelt, Daniel J. DeAngelo, Wendy Stock, Ben Sanford, William G. Blum, Clara D. Bloomfield, Richard M. Stone, Richard A. Larson

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30 Scopus citations

Abstract

The Cancer and Leukemia Group B (CALGB), now part of the Alliance for Clinical Trials in Oncology, conducted a multicenter, single-arm, phase 2 study in patients $60 years with FMS-like tyrosine kinase 3 (FLT3)–mutated acute myeloid leukemia (AML). In this study, sorafenib was added to daunorubicin and cytarabine-based induction and consolidation chemotherapy and was also continued for 12 months of maintenance therapy. The primary end point of the study was overall survival (OS) at 1 year in the FLT3 internal tandem duplication (FLT3-ITD) cohort. Fifty-four patients with a median age of 67 years (range, 60.3-82.7 years) were enrolled; 39 were FLT3-ITD patients (71%) and 15 were FLT3-TKD (29%) patients. The observed 1-year OS (95% confidence interval [CI]) was 62% (45%-78%) for the FLT3-ITD patients (meeting the primary end point 62% vs 30% for a historical control group, P, .0001) and 71% (42%-92%) for the FLT3-TKD patients. The median disease-free survival and OS were 12.2 months (95% CI, 5-16.9) and 15.0 months (95% CI, 10.4-20.1), respectively, in the FLT3-ITD group and 9.6 (95% CI, 1.9 to not available [NA]) and 16.2 months (95% CI, 5.0 to NA) for the FLT3-TKD group. This study suggests that the addition of sorafenib to chemotherapy for FLT3-ITD AML is feasible and may improve the survival of older adults with FLT3-mutated AML. This trial was registered at www.clinicaltrials.gov as #NCT01253070.

Original languageEnglish (US)
Pages (from-to)331-340
Number of pages10
JournalBlood Advances
Volume1
Issue number5
DOIs
StatePublished - Jan 24 2017

ASJC Scopus subject areas

  • Hematology

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    Uy, G. L., Mandrekar, S. J., Laumann, K., Marcucci, G., Zhao, W., Levis, M. J., Klepin, H. D., Baer, M. R., Powell, B. L., Westervelt, P., DeAngelo, D. J., Stock, W., Sanford, B., Blum, W. G., Bloomfield, C. D., Stone, R. M., & Larson, R. A. (2017). A phase 2 study incorporating sorafenib into the chemotherapy for older adults with FLT3-mutated acute myeloid leukemia: CALGB 11001. Blood Advances, 1(5), 331-340. https://doi.org/10.1182/bloodadvances.2016003053