Browsing by Author "Kaya, Emin"
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Item Addition of thalidomide (t) to oral melphalan/prednisone (mp) in patients with multiple myeloma: Initial results of a randomized trial from the Turkish myeloma study group.(Amer Soc Hematology, 2009-11-20) Beksaç, Mehmet Sinan; Haznedar, Rauf; Fıratlı, Tülin Tuğlular; Özdoğu, Hakan; Aydoğdu, İsmet; Konuk, Nahide; Sucak, Gulşan Ayhan; Kaygusuz, Işık; Karakuş, Savaş; Kaya, Emin; Gülbaş, Zafer; Özet, Gülsüm; Göker, Hakan; Ündar, Levent; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Hematoloji Anabilim Dalı.Item Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: Results of a randomized trial from the Turkish Myeloma Study Group(Wiley, 2011-01) Beksaç, Meral; Haznedar, Rauf; Tuğlular, Tulin Fıratlı; Özdoğu, Hakan; Aydoğdu, İsmet; Konuk, Nahide; Sucak, Gülşan; Kaygusuz, Işık; Karakuş, Sema; Kaya, Emin; Gülbaş, Zafer; Özet, Gülsüm; Göker, Hakan; Ündar, Levent; Ali, Rıdvan; Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı; 7201813027The combination of melphalan-prednisone-thalidomide (MPT) has been investigated in several clinical studies that differed significantly with regard to patient characteristics and treatment schedules. This prospective trial differs from previous melphalan-prednisone (MP) vs. MPT trials by treatment dosing, duration, routine anticoagulation, and permission for a crossover. Newly diagnosed patients with multiple myeloma (MM) (n = 122) aged greater than 55 yr, not eligible for transplantation were randomized to receive 8 cycles of M (9 mg/m2/d) and P (60 mg/m2/d) for 4 d every 6 wk (n = 62) or MP and thalidomide (100 mg/d) continuously (n = 60). Primary endpoint was treatment response and toxicities following 4 and 8 cycles of therapy. Secondary endpoints were disease-free (DFS) and overall survival (OS). Overall, MPT-treated patients were younger (median 69 yr vs. 72 yr; P = 0.016) and had a higher incidence of renal impairment (RI, 19% vs. 7%, respectively; P = 0.057). After 4 cycles of treatment (n = 115), there were more partial responses or better in the MPT arm than in the MP arm (57.9% vs. 37.5%; P = 0.030). However, DFS and OS were not significantly different between the arms after a median of 23 months follow-up (median OS 26.0 vs. 28.0 months, P = 0.655; DFS 21.0 vs. 14.0 months, P = 0.342, respectively). Crossover to MPT was required in 11 patients, 57% of whom responded to treatment. A higher rate of grade 3-4 infections was observed in the MPT arm compared with the MP arm (22.4% vs. 7.0%; P = 0.033). However, none of these infections were associated with febrile neutropenia. Death within the first 3 months was observed more frequently in the MP arm (n = 8, 14.0%) than in the MPT arm (n = 2, 3.4%; P = 0.053). Long-term discontinuation and dose reduction rates were also analyzed (MPT: 15.5% vs. MP: 5.3%; P = 0.072). Although patients treated with MPT were relatively younger and had more frequent RI, better responses and less early mortality were observed in all age groups despite more frequent discontinuation.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.Publication Efficacy and safety of ruxolitinib in patients with myelofibrosis: A retrospective and multicenter experience in Turkey(Tubitak Scientific & Technological Research Council Turkey, 2021-01-01) Soyer, Nur; Ali, Ridvan; Turgut, Mehmet; Haznedaroglu, Ibrahim C.; Yilmaz, Fergun; Aydogdu, Ismet; Karakus, Volkan; Ozgur, Gokhan; Kis, Cem; Ceran, Funda; Ilhan, Gul; Ozkan, Melda; Aslaner, Muzeyyen; Ince, Idris; Yavasoglu, Irfan; Gediz, Fusun; Sonmez, Mehmet; Guvenc, Birol; Ozet, Gulsum; Kaya, Emin; Vural, Filiz; Tobu, Mahmut; Durusoy, Raika; Pir, Ali; KAYA, PİR ALİ; Vural, Filiz; Şahin, Fahri; Saydam, Guray; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı.; 0000-0001-5118-6894; 0000-0001-9178-2850; 0000-0001-7423-7180; 0000-0002-7798-4349; 0000-0001-6621-3138; 0000-0002-2176-4371; 0000-0001-8605-8497; 0000-0003-1041-8462; W-3827-2017; ABH-5764-2020; AAB-7711-2022; JYO-9281-2024; W-2951-2017; HRC-6282-2023; W-7916-2019; B-7408-2009; A-4238-2018Background/aim: The aim of this study is to assess the efficacy and safety of ruxolitinib in patients with myelofibrosis. Materials and methods: From 15 centers, 176 patients (53.4% male, 46.6% female) were retrospectively evaluated. Results: The median age at ruxolitinib initiation was 62 (28-87) and 100 (56.8%) of all were diagnosed as PMF. Constitutional symptoms were observed in 84.7%. The median initiation dose of ruxolitinib was 30 mg (10-40). Dose change was made in 69 (39.2%) patients. Forty seven (35.6%) and 20 (15.2%) of 132 patients had hematological and nonhematological adverse events, respectively. The mean spleen sizes before and after ruxolitinib treatment were 219.67 +/- 46.79 mm versus 199.49 +/- 40.95 mm, respectively (p < 0.001). There was no correlation between baseline features and subsequent spleen response. Overall survival at 1-year was 89.5% and the median follow up was 10 (1-55) months. We could not show any relationship between survival and reduction in spleen size (p = 0.73). Conclusion: We found ruxolitinib to be safe, well tolerated, and effective in real-life clinical practice in Turkey. Ruxolitinib dose titration can provide better responses in terms of not only clinical benefit but also for long term of ruxolitinib treatment.Publication Evaluation of patients with pnh treated by eculizumab: Real world data from turkey(Amer Soc Hematology, 2019-11-13) Karadag, Fatma Keklik; Yenerel, Mustafa Nuri; Mehmet, Yilmaz; Teke, Hava Uskudar; Özkocaman, Vildan; Tuglular, Tulin; Erdem, Fuat; Unal, Ali; Ayyildiz, Orhan; Ozet, Gulsum; Ozkan, Melda; Kaya, Emin; Ayer, Mesut; Salim, Ozan; Guvenc, Birol; Ozdogu, Hakan; Mehtap, Ozgur; Sonmez, Mehmet; Guler, Nil; Hacioglu, Sibel Kabukcu; Aydogdu, Ismet; Bektas, Ozlen; Toprak, Selami Kocak; Kaynar, Lale; Yagci, Munci; Aksu, Salih; Tombak, Anil; Karakus, Volkan; Yavasoglu, Irfan; Onec, Birgul; Ozcan, Mehmet Ali; Undar, Levent; Ali, Ridvan; Ustun, Celalettin; Ilhan, Osman; Saydam, Guray; Sahin, Fahri; ÖZKOCAMAN, VİLDAN; ALİ, RIDVAN; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Hematoloji Anabilim Dalı.; AAH-1854-2021; GXD-8209-2022Publication Evolution of clinical characteristics of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab in Turkey: A multicenter retrospective analysis.(E-century Publishing Corp, 2021-01-01) Karadag, Fatma Keklik; Yenerel, Mustafa Nuri; Yilmaz, Mehmet; Uskudar, Hava; Tuglular, Tulin Firatli; Erdem, Fuat; Unal, Ali; Ayyildiz, Orhan; Ozet, Gulsum; Comert, Melda; Kaya, Emin; Ayer, Mesut; Salim, Ozan; Guvenc, Birol; Ozdogu, Hakan; Mehtap, Ozgur; Sonmez, Mehmet; Guler, Nil; Hacioglu, Sibel; Aydogdu, Ismet; Bektas, Ozlen; Toprak, Selami Kocak; Kaynar, Lale; Yagci, Munci; Aksu, Salih; Tombak, Anil; Karakus, Volkan; Yavasoglu, Irfan; Onec, Birgul; Ozcan, Mehmet Ali; Undar, Levent; Ilhan, Osman; Saydam, Guray; Sahin, Fahri; Ozkocaman, Vildan; ÖZKOCAMAN, VİLDAN; Ali, Ridvan; ALİ, RIDVAN; Bursa Uludağ Üniversitesi/Tıp Fakültesi; 0000-0003-2687-9167; 0000-0002-7798-4349; 0000-0001-8605-8497; 0000-0003-1977-0104; 0000-0002-8902-1283; 0000-0002-2176-4371; 0000-0003-0604-6475; 0000-0003-0757-9206; 0000-0001-7717-5827; 0000-0002-7195-1845; 0000-0001-9178-2850; 0000-0003-2824-1044; 0000-0001-7842-9702; AAA-2012-2021; S-4300-2019; GLU-6163-2022; HRC-6282-2023; ABH-5764-2020; W-2951-2017; ABE-4485-2021; ITT-2117-2023; IZQ-0529-2023; W-3827-2017; GLQ-6094-2022; HKM-4739-2023; ABC-8182-2021Paroxysmal nocturnal hemoglobinuria (PNH) is a rare X-linked genetic disorder. On the contrary to its name, it is a multisystemic disease and various symptoms other than hemoglobinuria could be occurred. It could be life threatening especially because of thromboembolic events. In the last decade, a terminal complement inhibition with eculizumab approved with promising results for PNH patients. We conducted this study to evaluate the long term experience of eculizumab therapy from Turkey for the first time. Our cohort included 138 patients with PNH treated with eculizumab between January 2008 and December 2018 at 28 centers in Turkey. Laboratory and clinical findings at the time of diagnosis and after eculizumab therapy were recorded retrospectively. The median age was 39 (range 18-84) years and median granulocyte PNH clone size was 74% (range 3.06-99.84%) at the time of diagnosis. PNH with bone marrow failure syndrome was detected in 49 patients and the rest of 89 patients had classical PNH. Overall 45 patients (32.6%) had a history of any prior thrombotic event before eculizumab therapy and only 2 thrombotic events were reported during the study period. Most common symptoms are fatigue (75.3%), hemoglobinuria (18.1%), abdominal pain (15.2%) and dysphagia (7.9%). Although PNH is commonly related with coombs negativity, we detected coombs positivity in 2.17% of patients. Seven months after the therapy, increased hemoglobin level was seen and remarkably improvement of lactate dehydrogenase level during the treatment was occurred. In addition to previous studies, our real life data support that eculizumab is well tolerated with no serious adverse events and improves the PNH related findings.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.