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
• FLT3 inhibitor
• fatigue
• health-related quality of life

Acknowledgements

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.

Author contributions

ER contributed to data collection and analysis, as well as the development of the manuscript. BP and MS contributed to the study design, data analysis, and the development of the manuscript. DC and CI were involved in data analysis and in the development of the manuscript. FF, AP, and YK were involved in data collection and the development of the manuscript.

Disclosure statement

ER: Pfizer, Celgene, Agios, Tolero, Incyte Pharmaceuticals, Genentech – non-financial support and/or advisory board honoraria and grant funding from Jazz Pharmaceuticals; DC: no conflicts to disclose; FF: no conflicts to disclose; AP: Amgen, Novartis, Roche, AbbVie, Astellas, Daichi, Jazz Pharmaceuticals – honoraria; YK: Astellas Pharma, Inc. – grants and personal fees; CI: IQVIA – employment; BP: Astellas Pharma, Inc. – employment; MS: Astellas Pharma, Inc. – employment.

Data availability statement

Researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials at www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing, see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx

Additional information

Funding

This study was funded by Astellas Pharma, Inc.