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

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dc.contributor.authorSaydam, Güray
dc.contributor.authorHaznedaroglu, Ibrahim Celalettin
dc.contributor.authorKaynar, Leylagul
dc.contributor.authorYavuz, Akif S.
dc.contributor.authorAli, Ridvan
dc.contributor.authorGuvenc, Birol
dc.contributor.authorAkay, Olga M.
dc.contributor.authorBaslar, Zafer
dc.contributor.authorOzbek, Ugur
dc.contributor.authorSonmez, Mehmet
dc.contributor.authorAydin, Demet
dc.contributor.authorPehlivan, Mustafa
dc.contributor.authorUndar, Bulent
dc.contributor.authorDagdas, Simten
dc.contributor.authorAyyildiz, Orhan
dc.contributor.authorAkin, Gulnur
dc.contributor.authorDag, Ilkiz M.
dc.contributor.authorIlhan, Osman
dc.date.accessioned2019-10-27T10:00:40Z
dc.date.available2019-10-27T10:00:40Z
dc.date.issued2018
dc.departmentEge Üniversitesien_US
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.en_US
dc.description.sponsorshipNovartis Pharmaceuticals CorporationNovartisen_US
dc.description.sponsorshipThis work was supported by the Novartis Pharmaceuticals Corporation.en_US
dc.identifier.doi10.1080/10245332.2018.1498167en_US
dc.identifier.endpage777en_US
dc.identifier.issn1024-5332
dc.identifier.issn1607-8454
dc.identifier.issue10en_US
dc.identifier.pmid29486663en_US
dc.identifier.startpage771en_US
dc.identifier.urihttps://doi.org/10.1080/10245332.2018.1498167
dc.identifier.urihttps://hdl.handle.net/11454/29748
dc.identifier.volume23en_US
dc.identifier.wosWOS:000448137100007en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherTaylor & Francis Ltden_US
dc.relation.ispartofHematologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectBCR-ABL1en_US
dc.subjectchronic myeloid leukemiaen_US
dc.subjectmolecular responseen_US
dc.subjectnilotiniben_US
dc.subjecttyrosine kinase inhibitoren_US
dc.titleFrontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: updated results with 2 years of follow-upen_US
dc.typeArticleen_US

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