This is a multicenter, national, non-interventional observational study with both retrospective and prospective components. The study aims to assess the incidence and characteristics of erectile dysfunction (ED) in male patients with chronic-phase chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) - imatinib, dasatinib, nilotinib, bosutinib, or ponatinib - as frontline therapy.
Eligible patients are adult males (aged 18-75) who initiated TKI treatment between January 1, 2015, and January 31, 2022. Data will be collected from medical records (retrospective phase) and through a 24-month follow-up (prospective phase). The retrospective data include ED onset, clinical assessments, BCR-ABL levels, ECG, and laboratory results. The prospective phase monitors ED development, cardiovascular events, and potential ED resolution in patients achieving treatment-free remission.
The primary objective is to estimate the cumulative incidence of ED from the start of TKI therapy. Secondary objectives include evaluating potential associations between TKI type and ED, the link between ED and cardiovascular toxicity, and the reversibility of ED in patients discontinuing therapy.
Approximately 350 patients are expected to be enrolled. No additional diagnostic procedures are planned beyond standard clinical care.
