Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+ acute myeloid leukemia.

Autor:	Hamilton BK; Blood and Marrow Transplant Program, Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH., Pandya BJ; Astellas, Northbrook, IL., Ivanescu C; IQVIA, Amsterdam, The Netherlands., Elsouda D; Astellas, Northbrook, IL., Hamadani M; Division of Hematology and Oncology, Department of Medicine, Medical College of Wisoncsin, Milwaukee, WI., Chen YB; Hematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital, Boston, MA., Levis MJ; Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD., Ueda Oshima M; Cancer Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA., Litzow MR; Division of Hematology and Transplant Center, Mayo Clinic, Rochester, MN., Soiffer RJ; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Ustun C; Division of Hematology Oncology and Cell Therapy, Rush University Medical Center, Chicago, IL., Perl AE; Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, PA., Singh AK; Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS., Geller N; Office of Biostatistics Research, National Heart, Lung, and Bood Institute, National Institutes of Health, Bethesda, MD., Hasabou N; Astellas, Northbrook, IL., Rosales M; Astellas, Northbrook, IL., Cella D; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL., Corredoira L; IQVIA, Barcelona, Spain., Pestana C; IQVIA, Barcelona, Spain., Horowitz MM; Division of Hematology and Oncology, Department of Medicine, Medical College of Wisoncsin, Milwaukee, WI., Logan B; Division of Hematology and Oncology, Department of Medicine, Medical College of Wisoncsin, Milwaukee, WI.
Jazyk:	angličtina
Zdroj:	Blood advances [Blood Adv] 2024 Oct 08; Vol. 8 (19), pp. 5091-5099.
DOI:	10.1182/bloodadvances.2024013746
Abstrakt:	Abstract: The Blood and Marrow Transplant (BMT) Clinical Trials Network conducted a phase 3 randomized trial comparing gilteritinib with placebo after allogeneic hematopoietic cell transplantation (HCT) for FLT3-ITD+ acute myeloid leukemia (AML). The primary analysis demonstrated no statistically significant difference in relapse-free survival (RFS); however, patients with FLT3-ITD measurable residual disease (MRD) peri-HCT had significantly longer RFS with gilteritinib. This analysis investigates the effect of post-HCT gilteritinib vs placebo on health-related quality of life (HRQOL). HRQOL was measured with Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), FACT-Leukemia (FACT-Leu), and EuroQOL-5 Dimensions (EQ-5D-5L) at post-HCT randomization; day 29; months 3, 6, 12, 18, 24; and/or end of therapy. HRQOL and clinically meaningful differences were summarized using descriptive statistics and compared using mixed model repeated measures to evaluate longitudinal change from baseline and stratified Cox model to evaluate time to improvement. HRQOL completion rate was acceptable (>70%) across all time points and measures. There were no differences in HRQOL scores at any time point between cohorts. Clinically meaningful and time to improvement in HRQOL were similar in both arms. Despite higher treatment-emergent adverse effects with gilteritinib, response to the question of being "bothered by side effects of treatment" did not differ between groups. Subgroup analysis of MRD-positive and negative patients demonstrated no differences in HRQOL between arms. For patients with FLT3-ITD+ AML undergoing HCT, gilteritinib maintenance was not associated with any difference in HRQOL or patient-reported impact of side effects. This trial was registered at www.ClinicalTrials.gov as #NCT02997202. (Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution.)
Databáze:	MEDLINE
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