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Başlık: Frontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: Updated results with 2 years of follow-up
Yazarlar: Saydam, Güray
Haznedaroğlu, İbrahim Celalettin
Kaynar, Leylagül
Yavuz, Akif S.
Ali, Rıdvan
Güvenç, Birol
Akay, Olga M.
Başlar, Zafer
Özbek, Uğur
Sönmez, Mehmet
Aydın, Demet
Pehlivan, Mustafa
Ündar, Bülent
Dağdaş, Simten
Ayyıldız, Orhan
Akın, Gülnur
Dağ, İlkiz M.
İlhan, Osman
Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.
Ali, Rıdvan
GXD-8209-2022
7201813027
Anahtar kelimeler: Hematology
BCR-ABL1
Chronic myeloid leukemia
Molecular response
Nilotinib
Tyrosine kinase inhibitor
Treatment-free remission
Diagnosed chronic-phase
Molecular response
Imatinib
Cytarabine
Interferon
Outcomes
Yayın Tarihi: 26-Kas-2018
Yayıncı: Taylor & Francis
Atıf: Saydam, G. vd. (2017). ''Frontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: Updated results with 2 years of follow-up''. Hematology, 23(10), 771-777.
Özet: Objectives: This report presents final results (24 months of follow-up) from the first prospective, national study of frontline nilotinib in chronic myeloid leukemia (CML) patients in Turkey. Methods: Patients with newly diagnosed Philadelphia chromosome-positive CML in chronic phase (CML-CP; N = 112) received nilotinib 300 mg twice daily. The primary endpoint, which was the cumulative rate of major molecular response (MMR; BCR-ABL1 <= 0.1% on the International Scale [BCR-ABL1(IS)]) by 12 months, was previously reported (66.1% [80% CI, 59.7%-72.0%]). ClinicalTrials.gov identifier NCT01274351 Results: By 24 months, 83.0% of patients achieved MMR, and 50.9% achieved MR4.5 (BCR-ABL1(IS) <= 0.0032%). Safety results at 24 months were consistent with those at 12 months. No additional deaths or disease progressions to accelerated phase/blast crisis were observed between 12 and 24 months. Discussion: Treatment with nilotinib 300 mg twice daily for 2 years provided high MMR with a good safety/tolerability profile in newly diagnosed CML-CP patients in Turkey. Assessment of MMR across time points showed increasing rates through 18 months, after which as lower rate of increase was observed. The safety profile of nilotinib 300 mg twice daily with 24 months of follow-up was similar to that observed at 12 months, and no new safety concerns were identified. These efficacy and safety findings are consistent with the results from the 12-month analysis of this study and from previous nilotinib studies. These findings support nilotinib as an option for frontline treatment of CML-CP. Conclusion: Frontline nilotinib treatment provided sustained efficacy, with good tolerability, over 24 months in newly diagnosed CML-CP patients.
URI: https://doi.org/10.1080/10245332.2018.1498167
https://www.tandfonline.com/doi/full/10.1080/10245332.2018.1498167
http://hdl.handle.net/11452/34018
ISSN: 1024-5332
1607-8454
Koleksiyonlarda Görünür:Scopus
Web of Science

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