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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, Osmanbjectives: 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.Öğe 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 DizObjective: 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.Öğe Patient characteristics and management practices in chronic myeloid leukemia in Turkey: reflections from an expert meeting(Taylor & Francis, 2022) Eskazan, Ahmet Emre; Ali, Rıdvan; Alnıgeniş, Ebru; Ayyıldız, Orhan; Haznedaroğlu, İbrahim; Kırkızlar, Onur; Kurtoğlu, Erdal; Malhan, Simten; Öksüz, Ergün; Polat, Özlem; Saydam, Güray; Sönmez, Mehmet; Toprak, Selami Koçak; Toptaş, Tayfur; Turgut, MehmetIntroduction The therapeutic landscape of chronic myeloid leukemia (CML) has evolved significantly since the introduction of imatinib. The European LeukemiaNet (ELN) recommendations serve as a guide for diagnosis, treatment, and monitorization of CML, but availability and accessibility of diagnostic tools and medications affect their applicability. Areas covered This article provides an overview of the current clinical management of CML in Turkey with reference to the key outputs of the online expert meeting held in November 2020. The applicability of the ELN 2020 recommendations for treating CML in clinical practice was also discussed. Expert opinion Imatinib is the only reimbursed and the most preferred first-line treatment in CML restricting the upfront use of second-generation tyrosine kinase inhibitors (TKIs), thereby limiting the applicability of treatment-free remission approach in Turkey. The ELN recommendations about using the EUTOS Long-Term Survival (ELTS) score for risk assessment and focusing on patient reported outcomes and quality of life can be enhanced with educational activities. The widespread availability of standardized technical infrastructure for diagnosing and monitoring CML will contribute to better disease management. Establishing a sustainable national database for CML is valuable for observing patient characteristics and disease outcomes as well as the impact of treatment patterns over time.Öğe Retrospective evaluation of patients treated with dasatinib for philadelphia positive leukemias: Turkish experience of 16 months(2009) İlhan, Osman; Altıntaş, Abdullah; Saydam, Güray; Haznedaroğlu, İbrahim C.; Yavuz, Selim; Tombuloğlu, Murat; Gülbaş, ZaferBu retrospektif çalışmada 114 KML hastasında ortalama tedavi süresi 7.94±4.53 aydı. Hastalar arasında hastalık durum dağılımı %78.1 kronik, %7.9 hızlanmış, %14 blastik faz şeklinde idi. Kronik, hızlanmış ve blastik fazlarda son imatinib dozları sırası ile 609.72±171.29, 714.29±106.90 ve 569.23±160.13 idi. Kronik ve hızlanmış fazlarda tam hematolojik cevap sırası ile %66.3 ve %44.4 olarak bulundu. Moleküler cevap RT-PCR’da bcr/abl transcript seviyeleri ile değerlenmişti. Tam moleküler cevap kronik fazda %27.0, hızlanmış fazda %11.1 ve blastik fazda %18.8 idi. Toplam 99 hastanın 77’si (%77.8) hayatta kalmıştı. Kaplan-Meier sağkalım analizinde 99 hastanın 16. ay genel sağkalım değeri %78 idi. Hastaların %69.2’sinde advers olay bildirilmezken, hastalık ilerlemesi ve evre 1-2 miyelosupresyon en sık bildirilmiş olan advers olaylardı. Hastaların çoğu tam hematolojik cevaba sahipti. Buna göre, dasatinib tedavisinin iyi tolere edildiği ve çoğunlukla hafif yan etkilerle birlikte olumlu çıktılar sağladığı söylenebilir.