Browsing by Author "Saydam, Güray"
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Publication Efficacy and safety of ibrutinib therapy in patients with chronic lymphocytic leukemia: Retrospective analysis of real-life data(Galenos Yayıncılık, 2021-08-16) Tombak, Anıl; Tanrıkulu, Funda Pepedil; Durusoy, Salih Sertaç; Dinçyürek, Hüseyin Derya; Kaya, Emin; Ümit, Elif Gülsüm; Yavaşoğlu, İrfan; Mehtap, Özgür; Deveci, Burak; Özcan, Mehmet Ali; Terzi, Hatice; Okay, Müfide; Sayınalp, Nilgün; Yılmaz, Mehmet; Okan, Vahap; Kızıklı, Alperen; Özcan, Ömer; Çetin, Güven; Demircioğlu, Sinan; Aydoğdu, İsmet; Saydam, Güray; Davulcu, Eren Arslan; İlhan, Gül; Uçar, Mehmet Ali; Özet, Gülsüm; Akpınar, Seval; Turgut, Burhan; Berber, İlhami; Kurtoğlu, Erdal; Sönmez, Mehmet; Batur, Derya Selim; Yıldırım, Rahşan; Özkocamaz, Vildan; Güneş, Ahmet Kürşad; Sahip, Birsen; Ertop, Şehmus; Akay, Olga Meltem; Baştürk, Abdulkadir; Doğu, Mehmet Hilmi; Akdeniz, Aydan; Ünal, Ali; Seyhanlı, Ahmet; Gürkan, Emel; Çekdemir, Demet; Ferhanoğlu, Burhan; Özkocamaz, Vildan; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı.; 0000-0003-0014-7398; DLC-4894-2022Objective: This study aimed to retrospectively evaluate the efficacy, safety, and survival outcome of single-agent ibrutinib therapy in chronic lymphocytic leukemia patients. Materials and Methods: A total of 136 patients (mean age +/- standard deviation: 64.6 +/- 10.3 years, 66.9% males) who had received at least one dose of ibrutinib were included in this retrospective multicenter, noninterventional hospital-registry study conducted at 33 centers across Turkey. Data on patient demographics, baseline characteristics, laboratory findings, and leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome including overall survival (OS) and progression-free survival (PFS), and safety data were analyzed. Results: Overall, 36.7% of patients were categorized as Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment response (complete or partial response), PFS time, and OS time were better with 0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and p=0.002, respectively). No significant difference was noted in treatment response rates or survival outcome with respect to the presence of comorbidity, bulky disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5). Conclusion: This real-life analysis confirms the favorable efficacy and safety profile of long-term ibrutinib treatment while emphasizing the potential adverse impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, and advanced Rai stage on patient compliance, treatment response, and survival outcomes.Item 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, 2018-11-26) 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, Bülent; Dağdaş, Simten; Ayyıldız, Orhan; Akın, Gülnur; Dağ, İlkiz M.; İlhan, Osman; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.; GXD-8209-2022; 7201813027Objectives: 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.Item 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; Haznedaroğlu, İbrahim Celalettin; Kaynar, Leylagül; Yavuz, Akif S.; Güvenç, Birol; Akay, Olga M.; Baslar, Zafer; Özbek, Uğur; Sönmez, Mehmet; Aydın, Demet; Pehlivan, Mustafa; Undar, Bülent; Dağdaş, Simten; Ayyıldız, Orhan M.; Akkaynak, Diyar Z.; Dağ, İlkiz M.; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.Item Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase(Taylor & Francis, 2016-07-28) Saydam, Güray; Haznedaroğlu, İbrahim Celalettin; Kaynar, Leylagül; Yavuz, Akif S.; Güvenç, Birol; Akay, Olga M.; Başlar, Zafer; Özbek, Uğur; Sönmez, Mehmet; Aydın, Demet; Pehlivan, Mustafa; Ündar, Bülent; Dağdaş, Simten; Ayyıldız, Orhan; Akkaynak, Diyar Z.; Dağ, İlkız M.; İlhan, Osman; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/Dahiliye Anabilim Dalı.; 7201813027Objective: 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.Publication Patterns of hydroxyurea prescription and use in routine clinical management of polycythemia vera: A multicenter chart review study(Galenos Yayincilik, 2020-01-01) Büyükaşık, Yahya; Turgut, Mehmet; Saydam, Güray; Yavuz, Selim; Ünal, Ali; Ar, Muhlis Cem; Ayyıldız, Orhan; Altuntaş, Fevzi; Okay, Mufide; Çiftçiler, Rafiye; Meletli, Özgür; Soyer, Nur; Mastanzade, Metban; Güven, Zeynep; Soysal, Teoman; Karakuş, Abdullah; Yiğenoğlu, Tuğce Nur; Uçar, Barış; Gökçen, Ece; Tuğlular, Tülin; Ali, Rıdvan; ALİ, RIDVAN; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı.; GXD-8209-2022Objective: This study aimed to evaluate real-life data on patterns of hydroxyurea prescription/use in polycythemia vera (PV).Materials and Methods: This retrospective chart review study included PV patients who had received hydroxyurea therapy for at least 2 months after PV diagnosis. Data were collected from 10 representative academic medical centers.Results: Of 657 patients, 50.9% were in the high-risk group (age 60 years and/or history of thromboembolic event). The median duration of hydroxyurea therapy was 43.40 months for all patients; 70.2% of the patients had ongoing hydroxyurea therapy at last followup. Hydroxyurea was discontinued in 22.4% of the patients; the most common reason was death (38.5%). The predicted time until hydroxyurea discontinuation was 187.8 months (standard error: +/- 21.7) for all patients. This duration was shorter in females (140.3 +/- 37.7 vs. 187.8 +/- 29.7) (p=0.08). This trend was also observed in surviving patients aged >= 50 years at hydroxyurea initiation (122.2 +/- 12.4 vs. 187.8 +/- 30.7, p=0.03). Among the patients who were still on hydroxyurea therapy, 40.3% had a hematocrit concentration of >= 45% at their last followup visit, and the rate of patients with at least one elevated blood cell count was 67.8%.Conclusion: Hydroxyurea prescription patterns and treatment aims are frequently not in accordance with the guideline recommendations. Its discontinuation rate is higher in females.Item Polycythemia vera: Diagnosis, clinical course, and current management(TÜBİTAK, 2018-08-09) Büyükaşık, Yahya; Ar, Cem; Turgut, Mehmet; Yavuz, Selim; Saydam, Güray; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Hematoloji Anabilim Dalı.; 7201813027Very important developments related to polycythemia vera (PV) have occurred during the last two decades. The discovery of Janus kinase (JAK) 2 mutations has changed both the diagnosis and clinical management of PV. Currently JAK2 molecular testing is essential in the diagnostic work-up and JAK2 mutation positivity is a major diagnostic criterion. The discovery of JAK2 mutations suggested that abnormal JAK-STAT signaling was a pivotal feature in the pathogenesis of Philadelphia-negative myeloproliferative neoplasms. This idea led to the development of JAK inhibitors. Currently ruxolitinib, a JAK1/JAK2 inhibitor, is also approved for PV patients with hydroxyurea resistance or intolerance. International collaborations have made it possible to describe disease characteristics and evolution better. Presently it is possible to quantify the symptomatic burden of the disease and to estimate prognosis. In spite of these developments, management of PV still largely depends on estimation of thromboembolic risk and trying to decrease the risk with or without cytoreductive medications. Different approaches have been proposed by international disease experts for the diagnosis, thromboembolic risk estimation, and drug selection. This paper aims to review clinical aspects of PV and propose a management algorithm. The authors also point to still unresolved questions and unmet needs in diagnosis and management.Publication Study for the diagnostic screening of paroxysmal nocturnal hemoglobinuria in older patients with unexplained anemia and/or cytopenia(Clin Lab Publ, 2020-01-01) Ozdemir, Zehra N.; Ilhan, Osman; Özet, Gülsüm; Falay, Mesude; Yenerel, Mustafa; Tuğlular, Tulin; Turgut, Mehmet; Güvenç, Birol; Unal, Ali; Ayyıldız, Orhan; Andıç, Neslihan; Hacihanefioğlu, Abdullah; Şahin, Fahri; Şencan, Mehmet; Özsan, Güner H.; Yıldırım, Rahşan; Tiftik, Eyüp N.; Tombak, Anil; Salim, Ozan; Kaya, Emin; Akay, Olga M.; Okan, Vahap; Pehlivan, Mustafa; Saydam, Güray; Ali, Ridvan; ALİ, RIDVAN; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı.; GXD-8209-2022Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired hematopoietic stem cell disease that may lead to weakness and death of patients, if unrecognized and untreated. Although consensus guidelines were reviewed recently for the diagnostic screening of PNH with multi-parameter flow cytometry (FCM), until now, no study has investigated the efficiency of such clinical indications in older patients.Methods: Overall, 20 centers participated in the study and a total of 1,689 patients were included, 313 of whom were at geriatric age and 1,376 were aged 18 - 64 years. We evaluated the efficiency of consensus clinical indications for PNH testing using FCM in peripheral blood samples and compared the results of older patients and patients aged 18 - 64 years.Results: PNH clones were detected positive in 7/313 (2.2%) of the older patients. Five (74.4%) of the patients with PNH clones had aplastic anemia, 1 had unexplained cytopenia, and 1 patient had myelodysplastic syndrome (MDS) with refractory anemia. PNH clones were not detected in any older patients who were screened for unexplained thrombosis, Coombs (-) hemolytic anemia, hemoglobinuria, and others (e.g., elevated lactate dehydrogenase (LDH), splenomegaly). We detected PNH clones in 55/1376 (4%) samples of the patients aged under 65 years. Forty-two (76.4%) patients with PNH clones had aplastic anemia, 2 patients had Coombs (-) hemolytic anemia, 3 patients had unexplained cytopenia, 1 patient had MDS with refractory anemia, 1 patient had hemoglobinuria, and 6 (10.9%) had others (e.g., elevated LDH, splenomegaly). PNH clones were not detected in any patients who were screened for unexplained thrombosis. There was no statistical difference between the geriatric population and patients aged 18 - 64 years in terms of clinical indications for PNH screening with FCM (p = 0.49).Conclusions: Our results showed that the current clinical indications for PNH screening with FCM were also efficient in older patients. We suggest that older patients with unexplained anemia, myelodysplastic syndrome with refractory anemia, and unexplained cytopenia should be screened for PNH with FCM to identify patients who would benefit from treatment.