Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy
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Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy. / Efficace, Fabio; Platzbecker, Uwe; Breccia, Massimo; Cottone, Francesco; Carluccio, Paola; Salutari, Prassede; Di Bona, Eros; Borlenghi, Erika; Autore, Francesco; Levato, Luciano; Finizio, Olimpia; Mancini, Valentina; D'Ardia, Stefano; Schlenk, Richard F; Melillo, Lorella; Fumagalli, Monica; Fiedler, Walter; Beltrami, Germana; Fracchiolla, Nicola Stefano; Bernardi, Massimo; Fazi, Paola; Annibali, Ombretta; Mayer, Karin; Voso, Maria Teresa; Vignetti, Marco.
In: BLOOD ADV, Vol. 5, No. 21, 09.11.2021, p. 4370-4379.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy
AU - Efficace, Fabio
AU - Platzbecker, Uwe
AU - Breccia, Massimo
AU - Cottone, Francesco
AU - Carluccio, Paola
AU - Salutari, Prassede
AU - Di Bona, Eros
AU - Borlenghi, Erika
AU - Autore, Francesco
AU - Levato, Luciano
AU - Finizio, Olimpia
AU - Mancini, Valentina
AU - D'Ardia, Stefano
AU - Schlenk, Richard F
AU - Melillo, Lorella
AU - Fumagalli, Monica
AU - Fiedler, Walter
AU - Beltrami, Germana
AU - Fracchiolla, Nicola Stefano
AU - Bernardi, Massimo
AU - Fazi, Paola
AU - Annibali, Ombretta
AU - Mayer, Karin
AU - Voso, Maria Teresa
AU - Vignetti, Marco
N1 - Copyright © 2021 American Society of Hematology.
PY - 2021/11/9
Y1 - 2021/11/9
N2 - 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.
AB - 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.
U2 - 10.1182/bloodadvances.2021004649
DO - 10.1182/bloodadvances.2021004649
M3 - SCORING: Journal article
C2 - 34529768
VL - 5
SP - 4370
EP - 4379
JO - BLOOD ADV
JF - BLOOD ADV
SN - 2473-9529
IS - 21
ER -
