New England Journal of Medicine· 2019Q1
Gilteritinib or Chemotherapy for Relapsed or Refractory <i>FLT3</i> -Mutated AML
- 1,254citations
- Q1SCImago
- 2019year
Short summary
Gilteritinib significantly improved overall survival (9.3 vs. 5.6 months) and complete remission rates (34.0% vs. 15.3%) compared to salvage chemotherapy in patients with relapsed or refractory FLT3-mutated AML.
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Key points
- Gilteritinib extended median overall survival to 9.3 months versus 5.6 months for salvage chemotherapy (HR 0.64, P<0.001).
- Complete remission with hematologic recovery was achieved by 34.0% of patients on gilteritinib, compared to 15.3% on chemotherapy (risk difference 18.6 pp).
- Median event-free survival was 2.8 months for gilteritinib and 0.7 months for chemotherapy.
- Grade 3+ adverse events were less frequent with gilteritinib, with common events including febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: -mutated AML. METHODS: -mutated AML in a 2:1 ratio to receive either gilteritinib (at a dose of 120 mg per day) or salvage chemotherapy. The two primary end points were overall survival and the percentage of patients who had complete remission with full or partial hematologic recovery. Secondary end points included event-free survival (freedom from treatment failure [i.e., relapse or lack of remission] or death) and the percentage of patients who had complete remission. RESULTS: Of 371 eligible patients, 247 were randomly assigned to the gilteritinib group and 124 to the salvage chemotherapy group. The median overall survival in the gilteritinib group was significantly longer than that in the chemotherapy group (9.3 months vs. 5.6 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.49 to 0.83; P<0.001). The median event-free survival was 2.8 months in the gilteritinib group and 0.7 months in the chemotherapy group (hazard ratio for treatment failure or death, 0.79; 95% CI, 0.58 to 1.09). The percentage of patients who had complete remission with full or partial hematologic recovery was 34.0% in the gilteritinib group and 15.3% in the chemotherapy group (risk difference, 18.6 percentage points; 95% CI, 9.8 to 27.4); the percentages with complete remission were 21.1% and 10.5%, respectively (risk difference, 10.6 percentage points; 95% CI, 2.8 to 18.4). In an analysis that was adjusted for therapy duration, adverse events of grade 3 or higher and serious adverse events occurred less frequently in the gilteritinib group than in the chemotherapy group; the most common adverse events of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%). CONCLUSIONS: -mutated AML. (Funded by Astellas Pharma; ADMIRAL ClinicalTrials.gov number, NCT02421939.).
The authors' abstract, as published at the source. New England Journal of Medicine, 2019 · DOI ↗
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Field: Hematology
HematologyMedicine