Safety and Tolerability of Nilotinib in Patients with Chronic Myeloid Leukemia during Routine Clinical Practice: Results from the ERASER Study from Greece-Reference-Cited by-同舟云学术

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

Published:2022-12-13 Issue:2 Volume:3 Page:66-76
ISSN:
Container-title:Journal of Clinical Haematology
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Author:

Symeonidis Argiris¹,Anagnostopoulos Achilles²,Ximeri Maria³,Kaiafa Georgia⁴,Kapsali Eleni⁵,Viniou Nora Athina⁶,Marinakis Theodoros⁷,Karakasis Dimitrios⁸,Pappa Vasiliki⁹,Vassilopoulos George¹⁰,Margaritis Dimitrios¹¹,Tabitsika Maria¹²,Dimou Maria⁶

Affiliation:

1. University of Patras Medical School, University General Hospital “Mary the Help” 26 504, Rion of Patras University Campus, Greece

2. General Hospital of Thessaloniki “G. Papanikolaou,” 570 10, Exochi, Thessaloniki, Greece

3. University General Hospital of Heraklion, Panepistimiou, 715 00, Herakleion, Crete, Greece

4. University General Hospital of Thessaloniki “AHEPA,” Kiriakidi 1, 546 21, Thessaloniki, Greece

5. University Hospital of Ioannina, Stavros Niarchos Avenue, 455 00, Ioannina, Greece

6. General Hospital of Athens “Laiko,” Sevastoupoleos 16, 115 26, Athens, Greece

7. General Hospital of Athens “G. Gennimatas,” Mesogeion 154, 115 27, Athens, Greece

8. General Hospital of Athens “Evaggelismos,” Ipsilantou 45-47, 106 76, Athens, Greece

9. University General Hospital of “Attiko,” Rimini 1, 124 62, Chaidari, Greece

10. University General Hospital of Larissa, Mezourlo, 411 10, Larissa, Greece

11. University Hospital of Alexandroupolis, 681 00, Alexandroupolis, Greece

12. Novartis S.A.C.I, Oncology Medical Affairs, Athens, Greece

Abstract

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.

Publisher

Scientific Archives LLC

Subject

History,History and Philosophy of Science,Multidisciplinary,Social Sciences (miscellaneous),Geography, Planning and Development,Marketing,Strategy and Management,Industrial relations,Business and International Management,Business, Management and Accounting (miscellaneous),Management of Technology and Innovation,Management Science and Operations Research,Information Systems and Management,Organizational Behavior and Human Resource Management,Electrical and Electronic Engineering,Computer Science Applications,Mechanical Engineering,Transportation,Computational Mechanics,Management Science and Operations Research,Computer Science Applications,Theoretical Computer Science,Computer Science Applications,General Mathematics,Software,Political Science and International Relations,Sociology and Political Science,Mechanical Engineering,Mechanics of Materials,Algebra and Number Theory

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