Regional real-world evidence on the safety and efficacy of tyrosine kinase inhibitors in patients with chronic myeloid leukemia (CML) is limited. This multicenter, observational, prospective study, ERASER, evaluated the safety and tolerability of nilotinib in routine clinical practice in Greece.
Adult patients with newly diagnosed BCR/ABL+ chronic phase (CP) CML and those with CP CML, resistant/intolerant to prior therapy were included in this study and followed up for 36 months. Nilotinib 300 mg/400 mg twice daily was prescribed, with appropriate dose adjustment by the investigator.
The analysis population (57 patients; median age, 55 years) remained in the study for a median of 34 months. Overall, 44 (77.2%) and 13 (22.8%) patients received nilotinib as first-line treatment and owing to resistance/intolerance to prior therapy, respectively. The most common adverse events (AEs) were thrombocytopenia in 8 (14%), neutropenia in 6 (10.5%), and blood bilirubin increased/hyperbilirubinemia in 10 (17.5%) patients. Permanent treatment discontinuation, including deaths and progression, occurred in 13 (22.8%) patients. Of 52 patients with available molecular response (MR), 30 achieved MR4.5 by end of the study.
The study affirms the long-term safety of nilotinib in real-world setting in Greece, in patients with newly diagnosed CML, and in those with resistance/intolerance to prior therapy.
Ph+ CML, Nilotinib, Observational study, Real world evidence, Tyrosine kinase inhibitors