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  • Küçük Resim
    Öğe
    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 and Francis Ltd., 2018) 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, Bulent; Dağdaş, Simten; Ayyıldız, Mehmet Orhan; Akın, Gülnur; Dağ, İlkiz M.; İlhan, Osman
    bjectives: 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-ABL1IS]) 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-ABL1IS ≤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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    A multi-center study on the efficacy of eltrombopag in management of refractory chronic immune thrombocytopenia: A real-life experience
    (Turkish Society of Hematology, 2019) Çekdemir, Demet; Güvenç, Serkan; Özdemirkıran, Füsun Gediz; Eser, Ali; Toptaş, Tayfur; Özkocaman, Vildan; Şahin, Handan Haydaroǧlu; Turak, Esra Ermiş; Esen, Ramazan; Cömert, Melda; Sadri, Sevil; Aslaner, Müzeyyen; Uncu Ulu, Bahar; Bapur, Derya Selim; Alacacıoğlu, İnci; Aydın, Demet; Tekinalp, Atakan; Namdaroǧlu, Sinem; Ceran, Funda; Tarkun, Pınar; Kiper, Demet; Çetiner, Mustafa; Yenerel, Mustafa Nuri; Demir, Ahmet Muzaffer; Yılmaz, Güven; Terzi, Hatice; Atilla, Erden; Malkan, Ümit Yavuz; Acar, Kadir; Öztürk, Erman; Tombak, Anıl; Sunu, Cenk; Salim, Ozan; Alayvaz, Nevin; Sayan, Özkan; Ozan, Ülkü; Ayer, Mesut; Gökgöz, Zafer; Andıç, Neslihan; Kızılkılıç, Ebru; Noyan, Figen; Özen, Mehmet; Tanrıkulu, Funda Pepedil; Alanoǧlu, Gü̧chan; Özkan, Hasan Atilla; Aslan, Vahap; Çetin, Güven; Erikçi, Alev Akyol; Deveci, Burak; Dursun, Fadime Ersoy; Dermenci, Hasan; Aytan, Pelin; Gündüz, Mehmet; Karakuş, Volkan; Özlü, Can; Demircioğlu, Sinan; Yanar, Olga Meltem Akay; Özatlı, Düzgün; Ündar, Levent; Tiftik, Eyüp Naci; Sucak, Ayhan Gülsan Türköz; Haznedaroğlu, İbrahim Celalettin; Özcan, Muhit; Şencan, Mehmet; Tombuloğu, Murat; Özet, Gülsüm Gulistan; Bilgir, Oktay; Turgut, Burhan; Özcan, Mehmet Ali; Payzın, Kadriye Bahriye; Sönmez, Mehmet; Ayyıldız, Orhan; Dal, Mehmet Sinan; Ertop, Şehmus; Turgut, Mehmet; Soysal, Teoman; Kaya, Emin; Ünal, Ali Ekrem; Pehlivan, Mustafa; Atagündüz, Işık Kaygusuz; Fıratlı, Tülin Tuğlular; Saydam, Güray; Küçükkaya, Reyhan Diz
    Objective: The aim of the present study was to evaluate the efficacy and safety of eltrombopag, an oral thrombopoietin receptor agonist, in patients with chronic immune thrombocytopenia (ITP). Materials and Methods: A total of 285 chronic ITP patients (187 women, 65.6%; 98 men, 34.4%) followed in 55 centers were enrolled in this retrospective cohort. Response to treatment was assessed according to platelet count (/mm3) and defined as complete (platelet count of >100,000/mm3), partial (30,000-100,000/mm3 or doubling of platelet count after treatment), or unresponsive (<30,000/mm3). Clinical findings, descriptive features, response to treatment, and side effects were recorded. Correlations between descriptive, clinical, and hematological parameters were analyzed. Results: The median age at diagnosis was 43.9±20.6 (range: 3-95) years and the duration of follow-up was 18.0±6.4 (range: 6-28.2) months. Overall response rate was 86.7% (n=247). Complete and partial responses were observed in 182 (63.8%) and 65 (22.8%) patients, respectively. Thirty-eight patients (13.4%) did not respond to eltrombopag treatment. For patients above 60 years old (n=68), overall response rate was 89.7% (n=61), and for those above 80 years old (n=12), overall response rate was 83% (n=10). Considering thrombocyte count before treatment, eltrombopag significantly increased platelet count at the 1st, 2nd, 3rd, 4th, and 8th weeks of treatment. As the time required for partial or complete response increased, response to treatment was significantly reduced. The time to reach the maximum platelet levels after treatment was quite variable (1-202 weeks). Notably, the higher the maximum platelet count after eltrombopag treatment, the more likely that side effects would occur. The most common side effects were headache (21.6%), weakness (13.7%), hepatotoxicity (11.8%), and thrombosis (5.9%). Conclusion: Results of the current study imply that eltrombopag is an effective therapeutic option even in elderly patients with chronic ITP. However, patients must be closely monitored for response and side effects during treatment. Since both response and side effects may be variable throughout the follow-up period, patients should be evaluated dynamically, especially in terms of thrombotic risk factors.