@article{f300a113488d47e9970f0fa719963f82,
title = "Patient-reported outcomes from the phase 3 ADMIRAL trial in patients with FLT3-mutated relapsed/refractory AML",
abstract = "Patient-reported outcomes (PROs) can inform treatment selection and assess treatment value in acute myeloid leukemia (AML). We evaluated PROs from the ADMIRAL trial (NCT02421939) in patients with FLT3-mutated relapsed/refractory (R/R) AML. PRO instruments consisted of Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu), Functional Assessment of Chronic Illness Therapy-Dyspnea Short Form (FACIT-Dys SF), EuroQoL 5-Dimension 5-Level (EQ-5D-5L), and leukemia treatment-specific symptom questionnaires. Clinically significant effects on fatigue were observed with gilteritinib during the first two treatment cycles. Shorter survival was associated with clinically significant worsening of BFI, FACT-Leu, FACIT-Dys SF, and EQ-5D-5L measures. Transplantation and transfusion independence in gilteritinib-arm patients were also associated with maintenance or improvement in PROs. Health-related quality of life remained stable in the gilteritinib arm. Hospitalization had a small but significant effect on patient-reported fatigue. Gilteritinib was associated with a favorable effect on fatigue and other PROs in patients with FLT3-mutated R/R AML.",
keywords = "Acute myeloid leukemia, fatigue, FLT3 inhibitor, health-related quality of life",
author = "Ritchie, {Ellen K.} and David Cella and Francesco Fabbiano and Arnaud Pigneux and Yoshinobu Kanda and Cristina Ivanescu and Pandya, {Bhavik J.} and Shah, {Manasee V.}",
note = "Funding Information: This study was funded by Astellas Pharma, Inc. This study was sponsored by Astellas Pharma, Inc. We acknowledge and thank the patients and their families for their participation in the ADMIRAL study. We also acknowledge and thank all the participating study sites, investigators, and research personnel for their support of the ADMIRAL trial. Medical writing support for this manuscript was provided by Kalpana Vijayan, PhD and Cheryl Casterline, MA, of Open Health Medical Communications (Chicago, IL) and was supported by the study sponsor. Funding Information: This study was sponsored by Astellas Pharma, Inc. We acknowledge and thank the patients and their families for their participation in the ADMIRAL study. We also acknowledge and thank all the participating study sites, investigators, and research personnel for their support of the ADMIRAL trial. Medical writing support for this manuscript was provided by Kalpana Vijayan, PhD and Cheryl Casterline, MA, of Open Health Medical Communications (Chicago, IL) and was supported by the study sponsor. Publisher Copyright: {\textcopyright} 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.",
year = "2023",
doi = "10.1080/10428194.2023.2186731",
language = "English (US)",
volume = "64",
pages = "938--950",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Informa Healthcare",
number = "5",
}
