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Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Retraction of vol 17, pg 1851, 2016)

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2018-10-21

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Saydam, Güray
Haznedaroğlu, İbrahim C.
Kaynar, Leylagül
Yavuz, Akif S.
Ali, Rıdvan
Güvenç, Birol
Akay, Olga M.
Başlar, Zafer
Özbek, Uğur
Sönmez, Mehmet

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Abstract

Objectives: 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.

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Early molecular response, Alpha plus cytarabine, Follow-up, Imatinib-resistant, Interferon, Inhibitor, Amn107, Bcr-abl1, Chronic myeloid leukemia, Molecular response, Nilotinib, Tyrosine kinase inhibitor, Science & technology, Life sciences & biomedicine, Hematology, Hematology

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