Long-Term Quality of Life of Acute Promyelocytic Leukemia Patients Treated with Arsenic Trioxide versus Chemotherapy.

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) versus 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 EORTC QLQ-C30, the EORTC QLQ-CIPN20 and the SF-36. The prevalence of late comorbidities and health problems was also assessed. The clinical significance of differences was evaluated based on predefined thresholds. This study was registered at ClinicalTrials.gov (NCT03096496). One hundred sixty-one out 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 two largest clinically meaningful differences in the EORTC QLQ-C30 were observed for role functioning (Δ=8.4, 95% 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 two 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.