Abstract
BACKGROUND: The objective of this study was to assess patient-reported outcomes (PROs), including health-related quality of life (HRQoL) and anxiety and depression symptoms, and to identify associated variables in patients with tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia (CML) in chronic-phase (CP) or accelerated-phase (AP) who were receiving olverembatinib. METHODS: Patients in multicenter studies were invited to complete the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 Questionnaire, the Self-Rating Anxiety Scale, and the Self-Rating Depression Scale at baseline and regularly during olverembatinib therapy. The time trends in PROs were estimated with a linear model using a generalized estimating equation based on an independent working correlation matrix. A generalized estimating equation model was used to assess the variables associated with PROs. RESULTS: In total, 146 patients with CML-CP or CML-AP were included in this study. Scores on seven items from the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 Questionnaire, including global health, physical functioning, emotional functioning, fatigue, dyspnea, diarrhea, and financial difficulties, improved significantly over time during olverembatinib therapy. In multivariate analysis, age younger than 40 years was significantly associated with greater improvement in social functioning (p = .033), and CML-CP (vs. CML-AP) was associated with greater improvements in dyspnea (p = .031) and diarrhea (p = .031) over time. Scores on the Self-Rating Anxiety Scale and the Self-Rating Depression Scale decreased significantly over time during olverembatinib treatment (p < .001). CONCLUSIONS: The authors concluded that HRQoL significantly improved over time during olverembatinib therapy in heavily treated patients with TKI-resistant CML, especially among those who were younger and those who had CML-CP. Anxiety symptoms also significantly decreased over time.