The experience of patients with acute myeloid leukemia in remission post-transplant

Abstract

The symptoms of acute myeloid leukemia (AML) and its treatment can negatively impact patient functioning and quality of life. Through concept elicitation interviews, we sought to evaluate the experience of patients with AML in remission following hematopoietic stem cell transplant (HSCT). Thirty patients with AML in remission post-HSCT, and eight clinicians with experience treating such patients, were asked to identify symptoms and impacts associated with AML and/or its treatment. The findings were used to develop an AML conceptual disease model to reflect the experience of these patients. We identified five symptoms and six impacts that were salient to patients with AML in remission post-HSCT. Although clinician and patient perspectives largely aligned, emotional and cognitive impacts were most important to patients, whereas clinicians focused on physical impacts. This model could be used to ensure patient-reported outcome measures included in clinical trials are reflective of the post-HSCT AML patient experience.

Keywords:

• Leukemic progenitor cells
• clinical results
• transplant toxicity
• myeloid leukemias and dysplasias

Ethical approval

Interviews were approved by the WIRB-Copernicus Group® Institutional Review Board (Review #: 20204118). Each patient provided informed consent online for screening and study participation prior to the interviews.

Author contributions

All authors met the International Committee of Medical Journal Editors criteria for authorship. All authors substantially contributed to at least one of the following: study design (DC, KK, AdlM, FT, and MVS), acquisition (DC, KK, AdlM, FT, and MVS), analysis (BJP, DC, KK, AdlM, MVS, and TWL), or interpretation of study data (BJP, DC, KK, AdlM, MVS, and TWL). All authors have seen and contributed to the revision of the manuscript. All authors read and approved the final manuscript for publication and agree to be accountable for all aspects of the work.

Disclosure statement

All authors report non-financial support from Astellas during the conduct of the study. KK and FT are employees of IQVIA, a CRO contracted to generate data on behalf of Astellas. AdlM was an employee of IQVIA during the conduct of the study. BJP is an employee of Astellas. MVS was an employee of Astellas during the conduct of the study. TWL received grants from AstraZeneca, CareVive, GSK, Janssen, Bristol Myers Squibb, and Jazz Pharmaceuticals; royalties from UpToDate; consulting fees from AbbVie, Astellas, Agios/Servier, Bristol Myers Squibb/Celgene, Flatiron, GSK, Genentech, Pfizer, BlueNote Therapeutics, Novartis, and AstraZeneca; and honoraria and support for attending meetings from AbbVie, Agios/Servier, and Bristol Myers Squibb/Celgene.

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 initiated and funded by Astellas Pharma Global Development, Inc. Medical writing support was provided by Eden Shaw, BSc, of Lumanity, and funded by Astellas Pharma Global Development, Inc. TWL is supported by a ‘Scholar in Clinical Research’ grant from the Leukemia and Lymphoma Society.