Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy.

Autor:	Efficace F; Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy., Platzbecker U; Medical Clinic and Polyclinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany., Breccia M; Hematology, Department of Translational and Precision Medicine, University Sapienza Rome, Roma, Italy., Cottone F; Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy., Carluccio P; Hematology and Bone Marrow Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy., Salutari P; Haematology, Pescara Hospital, Pescara, Italy., Di Bona E; Division of Hematology, San Bortolo Hospital, Vicenza, Italy., Borlenghi E; Hematology, ASST-Spedali Civili, Brescia, Italy., Autore F; Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Levato L; Department of Hematology-Oncology, Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy., Finizio O; Division of Hematology, Cardarelli General Hospital, Naples, Italy., Mancini V; Department of Hematology and Oncology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy., D'Ardia S; Division of Hematology, Department of Oncology, Presidio Molinette, AOU Città della Salute e della Scienza di Torino, Turin, Italy., Schlenk RF; Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.; NCT-Trial Center, German Cancer Research Center, Heidelberg, Germany., Melillo L; Division of Hematology, IRCCS 'Casa Sollievo della Sofferenza' Hospital, San Giovanni Rotondo, Italy., Fumagalli M; Hematology, San Gerardo Hospital, Monza, Italy., Fiedler W; University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Beltrami G; Hematology and Bone Marrow Transplantation Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy., Fracchiolla NS; Hematology, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy., Bernardi M; Hematology and Bone Marrow Transplantation Unit, San Raffaele Scientific, Milano, Italy., Fazi P; Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy., Annibali O; Hematology and Stem Cell Transplantation Unit, Campus Bio-Medico University, Roma, Italy., Mayer K; Department of Internal Medicine III, University Hospital of Bonn, Bonn, Germany; and., Voso MT; Department of Biomedicine and Prevention, Università di Roma 'Tor Vergata', Rome, Italy., Vignetti M; Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
Jazyk:	angličtina
Zdroj:	Blood advances [Blood Adv] 2021 Nov 09; Vol. 5 (21), pp. 4370-4379.
DOI:	10.1182/bloodadvances.2021004649
Abstrakt:	The main objective of this study was to compare the long-term health-related quality of life of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) vs ATRA plus standard chemotherapy. Patients previously enrolled in the randomized controlled trial APL0406 were considered eligible for this follow-up study. The following patient-reported outcome measures were used: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30), the EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20), and the Short Form Health Survey 36 (SF-36). The prevalence of late comorbidities and health problems was also assessed. The clinical significance of differences was evaluated based on predefined thresholds. A total of 161 of 232 potentially eligible patients were analyzed, of whom 83 were treated with ATRA-ATO and 78 were treated with ATRA chemotherapy. The median time since diagnosis of the study sample was 8 years. The 2 largest clinically meaningful differences in the EORTC QLQ-C30 were observed for role functioning (Δ = 8.4; 95% confidence interval [CI], 0.5 to 16.3) and dyspnea (Δ = -8.5; 95% CI, -16.4 to -0.7), favoring patients treated with ATRA-ATO. With regard to the SF-36 results, a clinically relevant better physical component score (Δ = 4.6; 95% CI, 1.3 to 7.8) was observed in patients treated with ATRA-ATO, but this was not the case for the mental component score. The 2 groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities. Overall, our findings suggest that the greater and more sustained antileukemic efficacy of ATRA-ATO is also associated with better long-term patient-reported outcomes than ATRA chemotherapy. This study was registered at www.clinicaltrials.gov as #NCT03096496. (© 2021 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
Databáze:	MEDLINE
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