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    Frontline nilotinib treatment in Turkish patients with Philadelphia chromosome-positive chronic Myeloid Leukemia in chronic phase: updated results with 2 years of follow-up
    (Taylor & Francis Ltd, 2018) Saydam, Güray; Haznedaroglu, Ibrahim Celalettin; Kaynar, Leylagul; Yavuz, Akif S.; Ali, Ridvan; Guvenc, Birol; Akay, Olga M.; Baslar, Zafer; Ozbek, Ugur; Sonmez, Mehmet; Aydin, Demet; Pehlivan, Mustafa; Undar, Bulent; Dagdas, Simten; Ayyildiz, Orhan; Akin, Gulnur; Dag, Ilkiz M.; Ilhan, Osman
    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.
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    Nilotinib Results in Improved Rates of Molecular Response in Turkish Newly Diagnosed CML-CP Patients: A 24-Month Update
    (Amer Soc Hematology, 2014) Saydam, Güray; Haznedaroglu, Ibrahim Celalettin; Kaynar, Leylagul; Yavuz, Akif S.; Ali, Ridvan; Guvenc, Birol; Akay, Olga M.; Baslar, Zafer; Ozbek, Ugur; Sonmez, Mehmet; Aydin, Demet; Pehlivan, Mustafa; Undar, Bulent; Dagdas, Simten; Ayyildiz, Orhan M.; Akkaynak, Diyar Z.; Dag, Ilkiz M.; Ilhan, Osman
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    Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase
    (Taylor & Francis Ltd, 2016) Saydam, Güray; Haznedaroglu, Ibrahim Celalettin; Kaynar, Leylagul; Yavuz, Akif S.; Ali, Ridvan; Guvenc, Birol; Akay, Olga M.; Baslar, Zafer; Ozbek, Ugur; Sonmez, Mehmet; Aydin, Demet; Pehlivan, Mustafa; Undar, Bulent; Dagdas, Simten; Ayyildiz, Orhan; Akkaynak, Diyar Z.; Dag, Ilkiz M.; Ilhan, Osman
    Objective: 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-ABL10.1% on the International Scale [BCR-ABL1(IS)]) by 12months.Methods: Patients with newly diagnosed CML-CP were treated with nilotinib 300mg twice daily. This analysis was based on the first 12months of follow-up in a 24-month study.Results and Conclusions: 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 12months. During the first year of treatment, 1 patient progressed to blast crisis and 2 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. These results support the use of nilotinib 300mg twice daily as a standard-of-care treatment option for patients with newly diagnosed CML-CP.
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    A Polymorphism in the IL-5 Gene is Associated with Inhibitor Development in Severe Hemophilia A Patients
    (Galenos Yayincilik, 2014) Fidanci, Inanc Deger; Zulfikar, Bulent; Kavakli, Kaan; Ar, M. Cem; Kilinc, Yurdanur; Baslar, Zafer; Caglayan, Server Hande
    Objective: A severe complication in the replacement therapy of hemophilia A (HA) patients is the development of alloantibodies (inhibitors) against factor VIII, which neutralizes the substituted factor. The primary genetic risk factors influencing the development of inhibitors are F8 gene mutations. Interleukins and cytokines that are involved in the regulation of B-lymphocyte development are other possible targets as genetic risk factors. This study assesses the possible involvement of 9 selected single nucleotide gene polymorphisms (SNPs) with interleukins (IL-4, IL-5, and IL-10), transforming growth factor beta 1 (TGF-beta 1), and interferon gamma (IFN-gamma) in inhibitor development in severely affected HA patients carrying a null mutation in the F8 gene. Materials and Methods: A total of 173 HA patients were screened for intron 22 inversion and null mutations (nonsense and deletions). Genotyping of a total of 9 SNPs in genes IL-4, IL-5, 1L-10, TGF-beta 1, and IFN-gamma in 103 patients and 100 healthy individuals was carried out. Results: An association analysis between 42 inhibitor (+) and 61 inhibitor (-) patients showed a significant association with the T allele of rs2069812 in the IL-5 gene promoter and patients with inhibitors (p=0.0251). The TT genotype was also significantly associated with this group with a p-value of 0.0082, odds ratio of about 7, and confidence interval of over 90%, suggesting that it is the recessive susceptibility allele and that the C allele is the dominant protective allele. Conclusion: The lack of other variants in the IL-5 gene of patients and controls suggests that rs2069812 may be a regulatory SNP and may have a role in B-lymphocyte development, constituting a genetic risk factor in antibody development.
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    Turkish Chronic Myeloid Leukemia Study: Retrospective Sectional Analysis of CML Patients
    (Galenos Yayincilik, 2013) Sahin, Fahri; Saydam, Güray; Comert, Melda; Uz, Burak; Yavuz, Akif Selim; Turan, Esra; Yonal, Ipek; Atay, Hilmi; Keltikli, Engin; Turgut, Mehmet; Pehlivan, Mustafa; Akay, Meltem Olga; Gurkan, Emel; Paydas, Semra; Kahraman, Selda; Demirkan, Fatih; Kirkizlar, Onur; Akpinar, Seval; Pamuk, Gulsum Emel; Demir, Muzaffer; Ozbas, Hasan Mucahit; Sonmez, Mehmet; Gulturk, Mine; Salihoglu, Ayse; Eskazan, Ahmet Emre; Ar, Cem; Sahin, Handan Haydaroglu; Ongoren, Seniz; Baslar, Zafer; Aydin, Yildiz; Yenere, Mustafa Nuri; Tuzuner, Nukhet; Ferhanoglu, Burhan; Haznedaroglu, Ibrahim C.; Ilhan, Osman; Soysal, Teoman
    Objective: here have been tremendous changes in treatment and follow-up of patients with chronic myeloid leukemia (CML) in the last decade. Especially, regular publication and updating of NCCN and ELN guidelines have provided enermous rationale and base for close monitorization of patients with CML. But, it is stil needed to have registry results retrospectively to evaluate daily CML practices. Materials and Methods: In this article, we have evaluated 1133 patients' results with CML in terms of demographical features, disease status, response, resistance and use of second-generation TKIs. Results: The response rate has been found relatively high in comparison with previously published articles, and we detected that there was a lack of appropriate and adequate molecular response assessment. Conclusion: We concluded that we need to improve registry systems and increase the availability of molecular response assessment to provide high-quality patient care.