Browsing by Author "Paydas, Semra"

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Castleman Disease: A Multicenter Case Series from Turkey
(2022) Gunduz, Eren; Kirkizlar, Hakki Onur; Umit, Elif Gulsum; Gulsaran, Sedanur Karaman; Ozkocaman, Vildan; Ozkalemkas, Fahir; Candar, Omer; Elverdi, Tugrul; Kucukyurt, Selin; Paydas, Semra; Ceneli, Ozcan; Karakus, Sema; Maral, Senem; Ekinci, Omer; Ipek, Yildiz; Kis, Cem; Guven, Zeynep Tugba; Akdeniz, Aydan; Celkan, Tiraje; Kucukdiler, Ayse Hilal Eroglu; Cagliyan, Gulsum Akgun; Sengoz, Ceyda Ozcelik; Karatas, Ayse; Bulduk, Tuba; Ozcan, Alper; Apak, Fatma Burcu Belen; Canbolat, Aylin; Kartal, Ibrahim; Oren, Hale; Toret, Ersin; Ozdemir, Gul Nihal; Ozturk, Sule Mine Bakanay; 35176839
Objective: Castleman disease (CD) is a rare disease also known as angiofollicular lymph node hyperplasia. The two main histological subtypes are the hyaline vascular and plasma cell variants. It is further classified as unicentric CD (UCD) or multicentric CD (MCD) according to the anatomical distribution of the disease and the number of lymph nodes involved. The aim of this multicenter study was to evaluate all cases of CD identified to date in Turkey to set up a national registry to improve the early recognition, treatment, and follow-up of CD. Materials and Methods: Both adult (n=130) and pediatric (n=10) patients with lymph node or involved field biopsy results reported as CD were included in the study. Patients' demographic information, clinical and laboratory characteristics, imaging study results, treatment strategies, and clinical outcomes were evaluated retrospectively. Results: A total of 140 patients (69 male and 71 female) with a diagnosis of UCD (n=73) or MCD (n=67) were included. The mean age was 39 years in the UCD group and 47 years in the MCD group. Female patients were more common in the UCD group. The most common histological subtype was hyaline vascular for both UCD and MCD patients. Asymptomatic patients were more common in the UCD group. Anemia, elevations of acute phase reactants, and hypoalbuminemia were more common in the MCD group. The most commonly used treatment strategies for UCD were surgical excision, rituximab, and radiotherapy, respectively. All UCD patients were alive at a median of 19.5 months of follow-up. The most commonly used treatment strategies for MCD were methyl prednisolone, R-CHOP, R-CVP, and rituximab. Thirteen MCD patients had died at a median of 34 months of follow-up. Conclusion: This study is important in presenting the patient characteristics and treatment strategies for CD from Turkey, with the potential of increasing awareness about CD. Treatment data may help in making decisions, particularly in countries that do not have access to siltuximab. However, larger prospective studies are needed to make definitive conclusions.
Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial
(2021) Sezer, Ahmet; Kilickap, Saadettin; Gumus, Mahmut; Bondarenko, Igor; Ozguroglu, Mustafa; Gogishvili, Miranda; Turk, Haci M.; Cicin, Irfan; Bentsion, Dmitry; Gladkov, Oleg; Clingan, Philip; Sriuranpong, Virote; Rizvi, Naiyer; Gao, Bo; Li, Siyu; Lee, Sue; McGuire, Kristina; Chen, Chieh I; Makharadze, Tamta; Paydas, Semra; Nechaeva, Marina; Seebach, Frank; Weinreich, David M.; Yancopoulos, George D.; Gullo, Giuseppe; Lowy, Israel; Rietschel, Petra; 33581821
Background We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%. Methods In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged >= 18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing. Findings Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17.9-not evaluable) with cemiplimab (n=283) versus 14.2 months (11.2-17.5) with chemotherapy (n=280; hazard ratio [HR] 0.57 [0.42-0.77]; p=0.0002). Median progression-free survival was 8.2 months (6.1-8.8) with cemiplimab versus 5.7 months (4.5-6.2) with chemotherapy (HR 0.54 [0.43-0.68]; p<0.0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy. Interpretation Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population. Copyright (C) 2021 Elsevier Ltd. All rights reserved.
Crizotinib Efficacy and Safety in Patients with Advanced NSCLC Harboring MET Alterations: A Real-Life Data of Turkish Oncology Group
(2022) Gurbuz, Mustafa; Kilickap, Saadettin; Bilici, Ahmet; Karadurmus, Nuri; Sezer, Ahmet; Sendur, Mehmet Ali Nahit; Paydas, Semra; Artac, Mehmet; Fulden Yumuk, Perran; Gursoy, Pinar; Uysal, Mukremin; Senol Coskun, Hasan; Tatli, Ali Murat; Selcukbiricik, Fatih; Disel, Umut; Koksoy, Elif Berna; Guven, Deniz Can; Ugrakli, Muzaffer; Akkus, Erman; Yucel, Sebnem; Erol, Cihan; Karakaya, Serdar; Sakalar, Teoman; Khanmammadov, Nijat; Paksoy, Nail; Demirkazik, Ahmet; 36550824
Crizotinib is a multikinase inhibitor, effective in non-small cell lung cancer (NSCLC) harboring mesenchymal-epidermal transition (MET) alterations. Although small prospective studies showed efficacy and safety of crizotinib in NSCLC with MET alterations, there is limited real-life data. Aim of this study is to investigate real-life efficacy and safety of crizotinib in patients with advanced NSCLC harboring MET alterations. This was a retrospective, multicenter (17 centers) study of Turkish Oncology Group. Patients' demographic, histological data, treatment, response rates, survival outcomes, and toxicity data were collected. Outcomes were presented for the study population and compared between MET alteration types. Total of 62 patients were included with a median age of 58.5 (range, 26-78). Major histological type was adenocarcinoma, and 3 patients (4.8%) had sarcomatoid component. The most common MET analyzing method was next generation sequencing (90.3%). MET amplification and mutation frequencies were 53.2% (n = 33) and 46.8% (n = 29), respectively. Overall response rate and disease control rate were 56.5% and 74.2% in whole study population, respectively. Median progression free survival (PFS) was 7.2 months (95% confidence interval [CI]: 3.8-10.5), and median overall survival (OS) was 18.7 months (95% CI: 13.7-23.7), regardless of treatment line. Median PFS was 6.1 months (95% CI: 5.6-6.4) for patients with MET amplification, whereas 14.3 months (95% CI: 6.7-21.7) for patients with MET mutation (P = .217). Median PFS was significantly longer in patients who have never smoked (P = .040), have good performance score (P < .001), and responded to the treatment (P < .001). OS was significantly longer in patients with MET mutation (25.6 months, 95% CI: 15.9-35.3) compared to the patients with MET amplification (11.0 months; 95% CI: 5.2-16.8) (P = .049). In never-smokers, median OS was longer than smoker patients (25.6 months [95% CI: 11.8-39.3] vs 16.5 months [95% CI: 9.3-23.6]; P = .049). The most common adverse effects were fatigue (50%), peripheral edema (21%), nausea (29%) and diarrhea (19.4%). Grade 3 or 4 adverse effects were observed in 6.5% of the patients. This real-life data confirms efficacy and safety of crizotinib in the treatment of advanced NSCLC harboring MET alteration.
Effectiveness of Bendamustine in Relapse or Refractory Lymphoma Cases: A Report From Turkey-The Turkish Oncology Group (TOG) Study.
(2017) Karadurmus, Nuri; Paydas, Semra; Ocal, Ramazan; Yildiz, Birol; Nayir, Erdinc; Dogan, Mutlu; Sumbul, Ahmet Taner; Surmeli, Zeki; Barista, Ibrahim; Ferhanoglu, Burhan; Ozgur, Gokhan; Erturk, Ismail; Ozaydin, Sukru; Petekkaya, Halil Ibrahim; Uskent, Necdet
Effectiveness of bendamustine in relapsed or refractory lymphoma cases: a Turkish Oncology Group study
(2021) Karadurmus, Nuri; Paydas, Semra; Esin, Ece; Surmeli, Zeki Gokhan; Yildiz, Birol; Erturk, Ismail; Nayir, Erdinc; Dogan, Mutlu; Sumbul, Ahmet Taner; Barista, Ibrahim; Gurkan, Emel; Ocal, Ramazan; Ferhanoglu, Burhan; Ozgur, Gokhan; Karakas, Yusuf; Lacin, Sahin; Ozaydin, Sukru; Petekkaya, Halil İbrahim; Uskent, Necdet; 34336021
Introduction: We aimed to investigate the efficacy and side effects of bendamustine in relapsed/refractory lymphoma patients in Turkey. Material and methods: In this retrospective study, we included relapsed/refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) patients who underwent multiple lines of chemotherapy. The primary endpoint was to determine the objective response and toxicity. Results: Ninety-nine patients with a median age of 59.8 years were included in the study. Eighty-one patients had NHL (follicular lymphoma: 10, diffuse large B- cell lymphoma: 27, mantle-cell lymphoma: 18, marginal zone lymphoma: 9, small lymphocytic lymphoma/chronic lymphocytic leukemia: 17) and 18 patients had HL. The patients had previously received a median of three lines of chemotherapy (range: 2-8) except autologous stem cell transplantation (ASCT); 19 patients (HL: 11, NHL: 8) had undergone ASCT. The objective response rate (ORR) was 74.3%, the complete response rate was 57% (= 53), and the partial response rate was 16.6% (= 19). The overall survival (OS) rate at 1 year was 74.6%. The progression-free survival (PFS) rate at 1 year was 62.5%. The most common side effects were lymphopenia, anemia and neutropenia. Side effects which were observed as grade 3 and higher levels were lymphopenia (14.1%), neutropenia (10.1%) and fatigue (7.1%). Conclusions: Objective response rate of bendamustine was found to be 74.3% in relapsed/refractory HL and NHL patients. It appears to be an effective option as a salvage treatment for patients who have previously received multiple lines of therapy.
Elotuzumab Plus Pomalidomide or Lenalidomide is Able to Achieve Durable >= Vgpr Responses Among Immunomodulatory/Proteasome Inhibitor Refractory Myeloma Patients: A Report on Multicenter Experience From Turkey
(2019) Beksac, Meral; Seval, Guldane Cengiz; Paydas, Semra; Tuglular, Tulin Firatli; Arslan, Onder; Goker, Hakan; Kaynar, Leylagul; Altuntas, Fevzi; Atalay, Figen; Teke, Havva Uskudar; Bolaman, Ali Zahit; Pehlivan, Mustafa; Sonmez, Mehmet; Demir, Ahmet Muzaffer; Topcuoglu, Pervin; Yilmaz, Mehmet; Kabukcu, Sibel Hacioglu; Albayrak, Murat; Yurttas, Nurgul Ozer; Salihoglu, Ayse; Cakar, Merih Kizil; Gurman, Gunhan
Perspective of Turkish Medicine Students on Cancer, Cancer Treatments, Palliative Care, and Oncologists (ARES Study): a Study of the Palliative Care Working Committee of the Turkish Oncology Group (TOG)
(2020) Oktay, Esin; Levent, Mustafa; Gelincik, Hakan; Aktas, Gizem; Yumuk, Fulden; Koral, Lokman; Arpaci, Erkan; Keser, Murat; Akan, Ali; Kaci, Ebru; Karadurmus, Nuri; Degirmencioglu, Serkan; Turan, Merve; Uyeturk, Ummugul; Cabuk, Devrim; Avci, Nilufer; Toprak, Omer; Ergen, Arzu; Urvay, Semiha; Bayram, Evrim; Petekkaya, Emine; Nayir, Erdinc; Paydas, Semra; Yavuzsen, Tugba; Senler, Filiz Cay; Yaren, Arzu; Barutca, Sabri; Sahinler, Ismet; Ozyilkan, Ozgur; Tanrıverdi, Ozgur; 0000-0001-8825-4918; 30446981; AAD-2817-2021
Cancer is one of the most common causes of death all over the World (Rahib et al. in Cancer Res 74(11):2913-2921, 2014; Silbermann et al. in Ann Oncol 23(Suppl 3):iii15-iii28, 2012). It is crucial to diagnose this disease early by effective screening methods and also it is very important to acknowledge the community on various aspects of this disease such as the treatment methods and palliative care. Not only the oncologists but every medical doctor should be educated well in dealing with cancer patients. Previous studies suggested various opinions on the level of oncology education in medical schools (Pavlidis et al. in Ann Oncol 16(5):840-841, 2005). In this study, the perspectives of medical students on cancer, its treatment, palliative care, and the oncologists were analyzed in relation to their educational status. A multicenter survey analysis was performed on a total of 4224 medical school students that accepted to enter this study in Turkey. After the questions about the demographical characteristics of the students, their perspectives on the definition, diagnosis, screening, and treatment methods of cancer and their way of understanding metastatic disease as well as palliative care were analyzed. The questionnaire includes questions with answers and a scoring system of Likert type 5 (absolutely disagree = 1, completely agree = 5). In the last part of the questionnaire, there were some words to detect what the words "cancer" and "oncologist" meant for the students. The participant students were analyzed in two study groups; "group 1" (n = 1.255) were phases I and II students that had never attended an oncology lesson, and "group 2" (n = 2.969) were phases III to VI students that had attended oncology lessons in the medical school. SPSS v17 was used for the database and statistical analyses. A value of p < 0.05 was noted as statistically significant. Group 1 defined cancer as a contagious disease (p = 0.00025), they believed that early diagnosis was never possible (p = 0.042), all people with a diagnosis of cancer would certainly die (p = 0.044), and chemotherapy was not successful in a metastatic disease (p = 0.003) as compared to group 2. The rate of the students that believed gastric cancer screening was a part of the national screening policy was significantly more in group 1 than in group 2 (p = 0.00014). Group 2 had a higher anxiety level for themselves or their family members to become a cancer patient. Most of the students in both groups defined medical oncologists as warriors (57% in group 1 and 40% in group 2; p = 0.097), and cancer was reminding them of "death" (54% in group 1 and 48% in group 2; p = 0.102). This study suggested that oncology education was useful for the students' understanding of cancer and related issues; however, the level of oncology education should be improved in medical schools in Turkey. This would be helpful for medical doctors to cope with many aspects of cancer as a major health care problem in this country.
The real-life efficacy and safety of osimertinib in pretreated advanced non-small cell lung cancer patients with T790M mutation: a Turkish Oncology Group Study
(2021) Hizal, Mutlu; Bilgin, Burak; Paksoy, Nail; Acikgoz, Ozgur; Sezer, Ahmet; Gurbuz, Mustafa; Ak, Naziye; Yucel, Sebnem; Ayhan, Murat; Erol, Cihan; Demirkiran, Aykut; Mandel, Nil Molinas; Shbair, Abdallah; Gokmen, Ivo; Basoglu, Tugba; Paydas, Semra; Demiray, Atike Gokcen; Iriagac, Yakup; Sakalar, Teoman; Zeynelgil, Esra; Tatli, Ali Murat; Bahceci, Aykut; Guven, Deniz Can; Caner, Burcu; Can, Alper; Gulmez, Ahmet; Karakas, Yusuf; Yalcin, Bulent; Demirkazik, Ahmet; Bilici, Ahmet; Aydiner, Adnan; Yumuk, Perran Fulden; Sendur, Mehmet Ali Nahit; 34331582
Introduction Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose disease progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation. Materials and methods This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety. Results Of 163 patients, 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13-month follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion Osimertinib is a highly effective option in second- or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.