Journal
BLOOD ADVANCES
Volume 1, Issue 5, Pages 331-340Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/bloodadvances.2016003053
Keywords
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Categories
Funding
- Dana-Farber/Partners CancerCare Lead Academic Participating Site (LAPS) (Boston, MA)
- Dartmouth College
- Norris Cotton Cancer Center LAPS (Lebanon, NH)
- Delaware/Christiana Care NCI Community Oncology Research Program (Newark, DE) [U10CA045418, UG1CA189819]
- Eastern Maine Medical Center Cancer Care (Brewer, ME)
- Northwell Health NCORP (Manhasset, NY)
- Ohio State University Comprehensive Cancer Center LAPS (Columbus, OH)
- Southeast Clinical Oncology Research Consortium NCORP (Winston-Salem, NC)
- University of Chicago Comprehensive Cancer Center LAPS (Chicago, IL)
- University of Maryland/Greenebaum Cancer Center (Baltimore, MD)
- University of Vermont College of Medicine (Burlington, VT)
- VCU Massey Cancer Center Minority Underserved NCORP (Richmond, VA)
- Wake Forest University Health Sciences (Winston-Salem, NC)
- Washington University
- Siteman Cancer Center LAPS (Saint Louis, MO)
- Weill Medical College
- National Cancer Institute of the National Institutes of Health [U10CA180867, U10CA180850, U10CA180836, U10CA180833, U10CA180821, U10CA180882, K23CA140707, P50CA100632]
- National Cancer Institute [U10CA032291, U10CA041287, U10CA031983, U10CA003927, U10CA077440, U10CA033601]
- [U10CA004326]
- [U10CA180854]
- [U10CA035279]
- [UG1CA189850]
- [U10CA077658]
- [U10CA045808]
- [UG1CA189858]
- [10CA077406]
- [U10CA052784]
- [UG1CA189869]
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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.
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