Publication:
Frontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: Updated results with 2 years of follow-up

dc.contributor.authorSaydam, Güray
dc.contributor.authorHaznedaroğlu, İbrahim Celalettin
dc.contributor.authorKaynar, Leylagül
dc.contributor.authorYavuz, Akif S.
dc.contributor.authorAli, Rıdvan
dc.contributor.authorGüvenç, Birol
dc.contributor.authorAkay, Olga M.
dc.contributor.authorBaşlar, Zafer
dc.contributor.authorÖzbek, Uğur
dc.contributor.authorSönmez, Mehmet
dc.contributor.authorAydın, Demet
dc.contributor.authorPehlivan, Mustafa
dc.contributor.authorÜndar, Bülent
dc.contributor.authorDağdaş, Simten
dc.contributor.authorAyyıldız, Orhan
dc.contributor.authorAkın, Gülnur
dc.contributor.authorDağ, İlkiz M.
dc.contributor.authorİlhan, Osman
dc.contributor.buuauthorAli, Rıdvan
dc.contributor.departmentTıp Fakültesi
dc.contributor.departmentİç Hastalıkları Ana Bilim Dalı
dc.contributor.researcheridGXD-8209-2022
dc.contributor.scopusid7201813027
dc.date.accessioned2023-09-25T10:52:17Z
dc.date.available2023-09-25T10:52:17Z
dc.date.issued2018-11-26
dc.description.abstractObjectives: 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.
dc.description.sponsorshipNovartis
dc.identifier.citationSaydam, 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.
dc.identifier.endpage777
dc.identifier.issn1024-5332
dc.identifier.issn1607-8454
dc.identifier.issue10
dc.identifier.pubmed29996726
dc.identifier.scopus2-s2.0-85049789573
dc.identifier.startpage771
dc.identifier.urihttps://doi.org/10.1080/10245332.2018.1498167
dc.identifier.urihttps://www.tandfonline.com/doi/full/10.1080/10245332.2018.1498167
dc.identifier.urihttp://hdl.handle.net/11452/34018
dc.identifier.volume23
dc.identifier.wos000448137100007
dc.indexed.wosSCIE
dc.language.isoen
dc.publisherTaylor & Francis
dc.relation.collaborationYurt içi
dc.relation.collaborationSanayi
dc.relation.journalHematology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectHematology
dc.subjectBCR-ABL1
dc.subjectChronic myeloid leukemia
dc.subjectMolecular response
dc.subjectNilotinib
dc.subjectTyrosine kinase inhibitor
dc.subjectTreatment-free remission
dc.subjectDiagnosed chronic-phase
dc.subjectMolecular response
dc.subjectImatinib
dc.subjectCytarabine
dc.subjectInterferon
dc.subjectOutcomes
dc.subject.emtreeNilotinib
dc.subject.emtree4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
dc.subject.emtreePyrimidine derivative
dc.subject.emtreeAcute pancreatitis
dc.subject.emtreeAdult
dc.subject.emtreeAged
dc.subject.emtreeArticle
dc.subject.emtreeBone marrow biopsy
dc.subject.emtreeBrain tumor
dc.subject.emtreeCancer growth
dc.subject.emtreeChronic myeloid leukemia
dc.subject.emtreeClinical assessment
dc.subject.emtreeDrug efficacy
dc.subject.emtreeDrug safety
dc.subject.emtreeDrug tolerability
dc.subject.emtreeEvent free survival
dc.subject.emtreeFemale
dc.subject.emtreeHuman
dc.subject.emtreeHuman tissue
dc.subject.emtreeMajor clinical study
dc.subject.emtreeMale
dc.subject.emtreeMulticenter study
dc.subject.emtreeNeutropenia
dc.subject.emtreePhase 2 clinical trial
dc.subject.emtreePhiladelphia 1 chromosome
dc.subject.emtreePriority journal
dc.subject.emtreeProgression free survival
dc.subject.emtreeReal time polymerase chain reaction
dc.subject.emtreeScoring system
dc.subject.emtreeThorax pain
dc.subject.emtreeThrombocytopenia
dc.subject.emtreeYoung adult
dc.subject.emtreeChronic myeloid leukemia
dc.subject.emtreeClinical trial
dc.subject.emtreeFollow up
dc.subject.emtreeGenetics
dc.subject.emtreeMetabolism
dc.subject.emtreeMiddle aged
dc.subject.emtreePathology
dc.subject.emtreeTurkey (bird)
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshFemale
dc.subject.meshFollow-up studies
dc.subject.meshHumans
dc.subject.meshLeukemia, myelogenous, chronic, BCR-ABL positive
dc.subject.meshMale
dc.subject.meshMiddle aged
dc.subject.meshPhiladelphia chromosome
dc.subject.meshPyrimidines
dc.subject.meshTurkey
dc.subject.scopusChronic Myeloid Leukemia; Imatinib; Protein Tyrosine Kinase Inhibitor
dc.subject.wosHematology
dc.titleFrontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: Updated results with 2 years of follow-up
dc.typeArticle
dc.wos.quartileQ4
dspace.entity.typePublication
local.contributor.departmentTıp Fakültesi/İç Hastalıkları Ana Bilim Dalı
local.indexed.atPubMed
local.indexed.atWOS

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