Research Article Open Access
Volume 3 | Issue 2 | DOI: https://doi.org/10.33696/haematology.3.051

Safety and Tolerability of Nilotinib in Patients with Chronic Myeloid Leukemia during Routine Clinical Practice: Results from the ERASER Study from Greece

  • 1University of Patras Medical School, University General Hospital “Mary the Help” 26 504, Rion of Patras University Campus, Greece
  • 2General Hospital of Thessaloniki “G. Papanikolaou,” 570 10, Exochi, Thessaloniki, Greece
  • 3University General Hospital of Heraklion, Panepistimiou, 715 00, Herakleion, Crete, Greece
  • 4University General Hospital of Thessaloniki “AHEPA,” Kiriakidi 1, 546 21, Thessaloniki, Greece
  • 5University Hospital of Ioannina, Stavros Niarchos Avenue, 455 00, Ioannina, Greece
  • 6General Hospital of Athens “Laiko,” Sevastoupoleos 16, 115 26, Athens, Greece
  • 7General Hospital of Athens “G. Gennimatas,” Mesogeion 154, 115 27, Athens, Greece
  • 8General Hospital of Athens “Evaggelismos,” Ipsilantou 45-47, 106 76, Athens, Greece
  • 9University General Hospital of “Attiko,” Rimini 1, 124 62, Chaidari, Greece
  • 10University General Hospital of Larissa, Mezourlo, 411 10, Larissa, Greece
  • 11University Hospital of Alexandroupolis, 681 00, Alexandroupolis, Greece
  • 12Novartis S.A.C.I, Oncology Medical Affairs, Athens, Greece
+ Affiliations - Affiliations

Corresponding Author

Argiris Symeonidis, argiris.symeonidis@yahoo.gr

Received Date: October 05, 2022

Accepted Date: December 05, 2022


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

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