Decitabine in older patients with AML: quality of life results of the EORTC-GIMEMA-GMDS-SG randomized phase 3 trial.

Autor:	Efficace F; Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy., Kicinski M; EORTC Headquarters, Brussels, Belgium., Coens C; EORTC Headquarters, Brussels, Belgium., Suciu S; EORTC Headquarters, Brussels, Belgium., van der Velden WJFM; Department of Hematology, Radboud University Medical Centre, Nijmegen, The Netherlands., Noppeney R; Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany., Chantepie S; Institut d'Hématologie de Basse Normandie, Centre Hospitalo Universitaire de Caen, Caen, France., Griskevicius L; Department of Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania., Neubauer A; Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany., Audisio E; SC Ematologia Città della Salute e della Scienza Torino, Torino, Italy., Luppi M; Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, University of Modena and Reggio Emilia, Azienda Ospedaliera Universitaria, Modena, Italy., Fuhrmann S; Department of Hematology and Oncology, Helios Hospital Berlin-Buch, Berlin, Germany., Foà R; Division of Hematology, Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy., Crysandt M; Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Aachen, Germany., Gaidano G; Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale and Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, Italy., Vrhovac R; Department of Haematology, University Hospital Centre Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia., Venditti A; Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy., Posthuma EFM; Department of Internal Medicine, Reinier de Graaf Hospital, Delft, The Netherlands.; Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands., Candoni A; Clinica Ematologica Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy., Baron F; University and CHU of Liège, Liège, Belgium., Legrand O; Service d'Hématologie Clinique et de Thérapie cellulaire, Hôpital Saint Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France., Mengarelli A; UOSD Ematologia, IRCCS Istituto Nazionale Tumori Regina Elena, Roma, Italy., Fazi P; Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy., Vignetti M; Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy., Giraut A; EORTC Headquarters, Brussels, Belgium., Wijermans PW; Department of Hematology, Haga Teaching Hospital, The Hague, The Netherlands., Huls G; University Medical Center Groningen, Groningen, The Netherlands., Lübbert M; Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg, Freiburg, Germany.
Jazyk:	angličtina
Zdroj:	Blood [Blood] 2024 Aug 01; Vol. 144 (5), pp. 541-551.
DOI:	10.1182/blood.2023023625
Abstrakt:	Abstract: We hypothesized that fit older patients with acute myeloid leukemia (AML) treated with decitabine (DEC) would report better health-related quality of life (HRQoL) outcomes than those receiving intensive chemotherapy (IC). We conducted a phase 3 randomized trial to compare DEC (10-day schedule) with IC (3+7) in older fit patients with AML. HRQoL was a secondary end point, and it was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in conjunction with its elderly module (EORTC QLQ-ELD14). The following scales were a priori selected for defining the primary end point: physical and role functioning, fatigue, pain, and burden of illness. HRQoL was assessed at baseline, at regeneration from cycle 2, and at 6 and 12 months after randomization, and also before allogeneic hematopoietic stem cell transplantation (allo-HSCT) and 100 days after transplantation. Overall, 606 patients underwent randomization. At 2 months, the risk of HRQoL deterioration was lower in the DEC arm than in the 3+7 arm; 76% (95% confidence interval [CI], 69-82) vs 88% (95% CI, 82-93); odds ratio, 0.43 (95% CI, 0.24-0.76; P = .003). No statistically significant HRQoL differences were observed between treatment arms at the long-term evaluation combining assessments at 6 and 12 months. HRQoL deteriorations between baseline and after allo-HSCT were observed in both arms. However, these deteriorations were not clinically meaningful in patients randomized to DEC, whereas this was the case for those in the 3+7 arm, in 4 of 5 primary HRQoL scales. Our HRQoL findings suggest that lower-intensity treatment with DEC may be preferable to current standard IC (3+7) in fit older patients with AML. This trial was registered at www.clinicaltrials.gov as #NCT02172872. (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)
Databáze:	MEDLINE
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