Tıp Fakültesi / Faculty of Medicine

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Author: search.filters.author.Sezer, Ahmet

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    First-Line Cemiplimab Monotherapy and Continued Cemiplimab Beyond Progression Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 50% Or More (EMPOWER-Lung 1): 35-Month Follow-Up From A Multicentre, Open-Label, Randomised, Phase 3 Trial
    (2023) Ozguroglu, Mustafa; Kilickap, Saadettin; Sezer, Ahmet; Gumus, Mahmut; Bondarenko, Igor; Gogishvili, Miranda; Nechaeva, Marina; Schenker, Michael; Cicin, Irfan; Ho, Gwo Fuang; Kulyaba, Yaroslav; Zyuhal, Kasimova; Scheusan, Roxana-Ioana; Garassino, Marina Chiara; He, Xuanyao; Kaul, Manika; Okoye, Emmanuel; Li, Yuntong; Li, Siyu; Pouliot, Jean-Francois; Seebach, Frank; Lowy, Israel; Gullo, Giuseppe; Rietschel, Petra; 37591293
    Background: Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression.Methods: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged >= 18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540.Findings: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 261 months (95% CI 221-318; 149 [52%] of 284 died) versus 133 months (105-162; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 057, 95% CI 046-071; p<00001), median progression-free survival was 81 months (95% CI 62-88; 214 events occurred) in the cemiplimab group versus 53 months (43-61; 236 events occurred) in the chemotherapy group (HR 051, 95% CI 042-062; p<00001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 66 months (61-93) and overall survival of 151 months (113-187). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signalsINTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer.Copyright (c) 2023 Elsevier Ltd. All rights reserved.
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    Patients with Distal Intestinal Gastric Cancer Have Superior Outcome with Addition of Taxanes to Combination Chemotherapy, While Proximal Intestinal and Diffuse Gastric Cancers do not: Does Biology and Location Predict Chemotherapy Benefit?
    (2015) Sedef, Ali Murat; Kose, Fatih; Sumbul, Ahmet Taner; Dogan, Ozlem; Besen, Ali Ayberk; Tatli, Ali Murat; Mertsoylu, Huseyin; Sezer, Ahmet; Muallaoglu, Sadik; Ozyilkan, Ozgur; Abali, Huseyin; 0000-0002-6445-1439; 0000-0002-6242-2802; 0000-0002-1932-9784; 0000-0002-7862-0192; 0000-0002-5573-906X; 0000-0001-8825-4918; 0000-0002-0156-5973; 25572818; AAD-2667-2020; IVU-7523-2023; -9530-2014; AAD-6910-2021; D-4793-2014; D-7660-2016; AAD-2817-2021; G-4827-2016; GZH-1913-2022
    Gastric cancer, with one million new cases observed annually, and its dismal prognosis, is one of the leading causes of cancer-related mortalities. Systemic chemotherapy is the main treatment modality in advanced gastric cancer patients. We aim to evaluate the predictive role of tumor localization and histopathology on choosing three or two-drug combination regimens. Consecutive 110 metastatic gastric adenocarcinoma patients who were admitted to the Baskent University Department of Medical Oncology and the Van Research and Training Hospital were included in the study. Data of patients were analyzed retrospectively. Median age of patients was 58 years (range 30-80). Proximal intestinal, distal intestinal, and diffuse gastric cancers were found in 35 (32 %), 64 (58 %), and 11 (10 %) patients, respectively. 5-fluoracil and platinum (PF) and PFtax were administered to 47 (43 %) and 63 (57 %) patients, respectively. Median progression-free survival (PFS) was 4.0 (95 % CI 2.5-5.6) and 7.4 months (95 % CI 6.0-8.7) for PF and PFtax groups, (p = 0.034). When we used tumor localization as strata in the PFS survival curve, PFtax produced significantly higher PFS rates only in distal intestinal-type gastric cancer, compared with PF (p = 0.03). Median overall survival (OS) was 9.0 (95 % CI 5.2-12.3) and 17.3 months (95 % CI 7.8-27) for PF and PFtax groups, (p = 0.010). When we used tumor localization as strata in the OS survival curve, PFtax produced significantly higher OS rates only in distal intestinal-type gastric cancer compared with PF (p = 0.015). Pathology and tumor location in gastric cancers may affect the outcome, the addition of taxanes as a third drug may significantly increase PFS and OS rate purely in distal intestinal-type gastric cancer but not in patients with proximal and diffuse-type gastric cancers.
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    Investigational Tests and Treatments Performed in Terminal-Stage Cancer Patients in Two Weeks Before Death: Supportive Care Study Group in Turkish Oncology Association
    (2014) Turker, Ibrahim; Komurcu, Seref; Arican, Ali; Senier, Filiz Cay; Coskun, Hasan Senol; Colak, Dilsen; Ucgul, Emel; Ata, Alper; Sezer, Ahmet; Ozyilkan, Ozgur; Cinkir, Havva Yesli; Arpaci, Fikrot; https://orcid.org/0000-0001-8825-4918; AAD-2817-2021
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    Association of Microrna 211 Expression with Prognosis in Colorectal Cancer: A Case-Control Study
    (2014) Sumbul, Ahmet Taner; Gogebakan, Bulent; Oztuzcu, Serdar; Yengil, Erhan; Sezer, Ahmet; Aball, Huseyin
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    Low Serum Levels of Vitamin D in Metastatic Cancer Patients: A Case-Control Study
    (2014) Sumbul, Ahmet Taner; Sezer, Ahmet; Kavvasoglu, Gamze; Batmaci, Celal Yucel; Yengil, Erhan; Yagiz, Abdullah Erman; Gultepe, Ihami; Abali, Huseyin; Ustun, Ihsan; Gokce, Cumali; https://orcid.org/0000-0002-6445-1439; https://orcid.org/0000-0001-5596-0920; 24493144; AAD-2667-2020; D-7660-2016
    Accompanying comorbidities observed during the cancer treatment usually affect the course and outcome of the therapy. Hypovitaminosis D, which is one of these conditions, is a resolvable problem, if recognized. In this study, we investigated whether the serum 25(OH) D levels of the patients who were presented to our outpatient clinic were different from the serum levels of the healthy population living in the same area. Our study included 90 patients who were presented to the Medical Oncology outpatient clinic and 90 age, gender, body mass index and ethnic origin matched controls without a known disease, who were presented to the outpatient clinics of the Departments of Internal Diseases and Family Medicine for routine controls. Blood count tests, detailed biochemistry tests (including serum levels of Cr, Ca and P), measurement of serum 25(OH) D levels and C-reactive protein were performed in serum samples of all of the patients and controls. Mean serum levels of 25(OH) D were 13.5 ng/ml (SD 5.1) in all cancer patients, 13.1 ng/ml (SD 4.2) in the patients who were presented for adjuvant therapy, 13.8 ng/ml (SD 5.5) in the patients who were presented at metastatic stage and 18.4 ng/ml (SD 12.5) in the controls. Mean serum CRP levels were 5.4 mg/dl (SD 1.2) in the control group, 8.4 mg/dl (SD 4.3) in the adjuvant therapy group and 20.3 (SD 16.8) in the patients with metastatic disease. Generally, all cancer patients (p 0.003) and the patients with metastatic cancer (p 0.004) had lower serum 25(OH) D levels compared to controls, and there was an inverse correlation between serum 25(OH) D and CRP levels in patients with metastatic cancer (p 0.036). In metastatic cancer patients, hypovitaminosis D may be a comorbidity and it is recommended to consider during initial evaluation and follow-up. Because it might improve these patients quality of life and chemotherapy adherence.
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    Being A Medical Oncologist Near the War Area
    (2014) Sumbul, Ahmet Taner; Sezer, Ahmet; Tonyali, Onder; Ozturk, Mehmet Akif; Abali, Huseyin; Ozyilkan, Ozgur; https://orcid.org/0000-0002-6445-1439; https://orcid.org/0000-0001-5596-0920; https://orcid.org/0000-0001-8825-4918; 24965429; AAD-2667-2020; D-7660-2016; AAD-2817-2021
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    The Clinicopathological and Survival Differences Between Never and Ever Smokers with Non-Small Cell Lung Cancer
    (2014) Muallaoglu, Sadik; Karadeniz, Cemile; Mertsoylu, Huseyin; Besen, Ali Ayberk; Sezer, Ahmet; Sedef, Ali Murat; Kose, Fatih; Ozyilkan, Ozgur; https://orcid.org/0000-0002-6242-2802; https://orcid.org/0000-0002-1932-9784; https://orcid.org/0000-0002-6445-1439; https://orcid.org/0000-0002-0156-5973; https://orcid.org/0000-0001-8825-4918; 24965406; IVU-7523-2023; M-9530-2014; AAD-2667-2020; G-4827-2016; AAD-2817-2021
    Purpose: Cigarette smoking was regarded as the most important carcinogenic factor of lung cancer, yet in recent years lung cancer in never-smokers is an increasingly prominent public health issue. The aim of this study was to assess the epidemiological and clinicopathological characteristics of never-smoker patients with non small cell lung cancer (NSCLC), focusing on clinical risk factors and survival. Methods: We retrospectively analyzed 290 NSCLC patients who presented between 2006 and 2011. Differences in clinical features and survival between never- and ever-smoker patients were analyzed. Student's t-test and Mann-Whitney U-test were used to assess the significance of the variables between the groups. Survival curves were calculated using Kaplan-Meier method. Hazard ratio (HR) for death and its 95% confidence interval (CI) were calculated by Cox regression analysis. Results: There were 243 (83.8%) ever-smokers and 47 (16.2%) never-smokers. In never-smokers females predominated (80.9%) as well as patients with adenocarcinomas (78.7%). At the time of analysis 143 (49.3%) patients had died. The 5-year overall survival (OS) rates were not significantly different between never- and ever-smokers (p=0.410). The median OS of all patients was 26 months (95% CI: 16.8-35.2). The median OS was 23 months (95% CI: 11.8-34.2)for never-smokers and 30 months (95% CI: 19.7-40.3) forever-smokers (p=0.410). Never-smokers tended to present with more advanced disease than ever-smokers (p<0.004) and also with more advanced age (p<0.001). The HR for death increased with poorer Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG 2-3), advanced stage (stage 3-4) and untreated patients. Slightly lower risk for death was registered in patients with adenocarcinoma vs those with squamous cell carcinoma (S CC). Conclusion: Although no difference in survival was seen, definite epidemiologic differences do exist between never-smokers and ever-smokers patients with NSCLC. Future efforts should focus on the underlying biological differences, and on identifying potential non-tobacco related risk factors in order to improve treatment strategies for these two groups of NSCLC patients.
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    Neutrophil-to-lymphocyte Ratio Predicts PSA Response, but not Outcomes in Patients with Castration-Resistant Prostate Cancer Treated with Docetaxel
    (2014) Sumbul, Ahmet Taner; Sezer, Ahmet; Abali, Huseyin; Kose, Fatih; Gultepe, Ilhami; Mertsoylu, Huseyin; Muallaoglu, Sadik; Ozyilkan, Ozgur; https://orcid.org/0000-0002-6445-1439; https://orcid.org/0000-0001-5596-0920; https://orcid.org/0000-0002-0156-5973; https://orcid.org/0000-0002-1932-9784; https://orcid.org/0000-0002-6242-2802; https://orcid.org/0000-0001-8825-4918; 24526335; AAD-2667-2020; D-7660-2016; G-4827-2016; M-9530-2014; IVU-7523-2023; AAD-2817-2021
    The neutrophil-to-lymphocyte ratio (NLR) is a marker of systemic inflammatory response and evidences for the relationship between NLR and the response to treatment gradually increases in cancer patients. In this study, we aimed to investigate the effect of the pretreatment NLR and other factors related to the patient on predicting the outcome of docetaxel + prednisone chemotherapy in prostate cancer patients who become castration resistant. Thirty-three metastatic castration-resistant prostate cancer patients those who were treated between 2009 and 2013 were included in our study. All data of the patients, including pathological, clinical, radiological, biochemical and hematological data, were assessed retrospectively using our database system. The median progression-free survival (PFS) was determined as 23.9 months (range 0.36-118.7) with androgen suppression therapy and 9.5 months (range 1.7-39.4) with docetaxel + prednisone therapy. NLR was found to be correlated with only posttreatment psa levels. In the NLR a parts per thousand currency sign3 group, the PSA levels were statistically significantly lower than the other group (r = 0.002). Furthermore, the relationships between the clinical response and PFS and the other pretreatment parameters of the patients were evaluated in order to predict which group would respond better to docetaxel + prednisone therapy after becoming androgen resistant. No relationship was found between any of the parameters and the response to therapy. Although NLR was found effective in predicting the PSA response in docetaxel + prednisone therapy, neither NLR nor any other clinical parameter was found effective in predicting the outcome and the role of NLR in the future of CRPC is questionable.
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    Cutaneous Melanoma in Turkey: Analysis of 1157 Patients in the Melanoma Turkish Study
    (2015) Abali, Huseyin; Celik, Ismail; Karaca, Burcak; Turna, Hande; Saglam, Esra Kaytan; Akman, Tulay; Oztop, Ilhan; Coskun, Hasan Senol; Turhal, Nazim Serdar; Sezer, Ahmet; Nayir, Erdinc; Demir, Gokhan; Budakoglu, Burcin; Issikdogan, Abdurrahman; Engin, Huseyin; Kilickap, Saadettin; Coskun, Ugur; Oyan, Basak; Harputluoglu, Hakan; Er, Ozlem; Kavgaci, Halil; Elkiran, Tamer; 26416068
    Purpose: To develop a large Turkish National Melanoma registry in order to define demographic and clinicopathologic characteristics of patients with melanoma. Methods: The data was collected from 1635 patients with melanoma through a web-based registry system in 22 centers. Herein we present the results of 1157 patients with cutaneous melanoma. Results: The patient median age was 56.4 years and 646 (55.8%) were males. The commonest subtype was superficial spreading type (357, 30.9%). The commonest primary site was the lower extremities (N=353, 30.5%). The most common Breslow thickness was 1-2 mm (361 patients, 43.5%). Only 104 (12.5%) patients had a thickness <1mm. Among 694 patients with available data, 136 (19.6%) presented with stage 4 disease while the most frequent stage was stage 3, encountered in 393 (56.6% patients). Conclusion: Our melanoma registry is the largest in our country providing a snapshot view of cutaneous melanoma and its care. Our patients presented with more advanced stages and they had worse prognosis compared to SEER database.
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    High Pretreatment Neutrophil-Lymphocyte Ratio: A Poor Prognostic Factor for Stage III Non-Small Cell Lung Cancer Patients
    (2015) Sumbul, Ahmet T.; Batmaci, Celal; Ucar, Edip; Kose, Fatih; Sedef, Ali M.; Yildirim, Berna; Mertsoylu, Huseyin; Sezer, Ahmet; Ozyilkan, Ozgur; 0000-0002-1932-9784; 0000-0001-8825-4918; 0000-0001-6661-4185; 0000-0002-5573-906X; M-9530-2014; AAD-2817-2021; V-5717-2017; D-4793-2014