Saydam, GürayHaznedaroğlu, İbrahim C.Kaynar, LeylagülYavuz, Akif S.Ali, RıdvanGüvenç, BirolAkay, Olga M.Başlar, ZaferÖzbek, UğurSönmez, MehmetAydın, DemetPehlivan, MustafaUndar, BülentDağdaş, SimtenAyyıldız, OrhanAkkaynak, Diyar Z.Akın, Gülnurİlhan, Osman2024-12-032024-12-032018-10-211024-5332https://doi.org/10.1080/10245332.2018.1444919https://www.tandfonline.com/doi/abs/10.1080/10245332.2018.1444919https://hdl.handle.net/11452/48830Objectives: Nilotinib is a BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of patients with chronic myeloid leukemia in chronic phase (CML-CP). This study was the first prospective evaluation of the efficacy and safety of nilotinib in Turkish patients with newly diagnosed CML-CP. The primary endpoint of the study was the rate of major molecular response (MMR; BCR-ABL1 <= 0.1% on the International Scale [BCR-ABL1(IS)]) by 12 months.Methods: Patients with newly diagnosed CML-CP were treated with nilotinib 300 mg twice daily. This analysis was based on the first 12 months of follow-up in a 24-month study. This study is registered with ClinicalTrials.gov (NCT01274351).Results: Of 112 patients enrolled, 66.1% (80% CI, 59.7-72.0%) achieved MMR and 22.3% achieved a deep molecular response of MR4.5 (BCR-ABL1(IS) <= 0.0032%) by 12 months. During the first year of treatment, one patient progressed to blast crisis and two patients died. Safety results were consistent with previous studies. Most adverse events (AEs) were grade 1/2. Most frequently reported nonhematologic AEs of any grade were elevations in bilirubin, alanine aminotransferase, and triglycerides.Conclusion: These results support the use of nilotinib 300 mg twice daily as a standard-of-care treatment option for patients with newly diagnosed CML-CP with low and intermediate risk.eninfo:eu-repo/semantics/openAccessEarly molecular responseAlpha plus cytarabineFollow-upImatinib-resistantInterferonInhibitorAmn107Bcr-abl1Chronic myeloid leukemiaMolecular responseNilotinibTyrosine kinase inhibitorScience & technologyLife sciences & biomedicineHematologyHematologyRetraction00070660000000123910.1080/10245332.2018.14449191607-8454