Fakülteler / Faculties
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Item Efficacy and Safety of the Proposed Bevacizumab Biosimilar BAT1706 Compared with Reference Bevacizumab In Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study(2023) Chen, Likun; Rangel, Jose David Gomez; Cil, Timucin; Li, Xingya; Cicin, Irfan; Shen, Yihong; Liu, Zhihua; Ozyilkan, Ozgur; Igor, Bondarenko; Chen, Jun; Oleksandr, Kostiuk; Chen, Zhendong; Zhang, Helong; Fu, Ziyi; Dong, Qingfeng; Song, Shuqiang; Yu, Jin-Chen; Zhang, Li; 37935428Background: BAT1706 is a proposed biosimilar of bevacizumab (Avastin (R)). We aimed to compare the efficacy and safety of BAT1706 with that of EU-sourced reference bevacizumab (EU-bevacizumab) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).Methods: Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU-bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75-1.33 (China National Medical Products Administration requirements), or 0.73-1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of -0.12 to 0.15 (EMA requirements).Results: In total, 649 randomized patients (BAT1706, n = 325; EU-bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). The ORR(18 )risk ratio of 1.08 (90% CI: 0.94-1.24) and the ORR(18 )risk difference of 0.03 (95% CI: -0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU-bevacizumab. The safety profile of BAT1706 was consistent with that of EU-bevacizumab and no new safety signals were observed.Conclusion: In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU-bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.Item 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-1913-2022Gastric 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.Item 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-2817-2021Item Epidemiology of Colorectal Cancer in Turkey: A Cross-Sectional Disease Registry Study (A Turkish Oncology Group Trial)(2015) Aykan, Nuri Faruk; Yalcin, Suayib; Turhal, N. Serdar; Ozdogan, Mustafa; Demir, Gokhan; Ozkan, Metin; Yaren, Arzu; Camci, Celalettin; Akbulut, Hakan; Artac, Mehmet; Meydan, Nezih; Uygun, Kazim; Isikdogan, Abdurrahman; Unsal, Diclehan; Ozyilkan, Ozgur; Arican, Ali; Seyrek, Ertugrul; Tekin, Salim Basol; Manavoglu, Osman; Ozet, Ahmet; Elkiran, Tamer; Disci, Rian; 0000-0001-8825-4918; 25835113; AAD-2817-2021Background/Aims: This study aimed to determine the epidemiological characteristics of colorectal cancer in Turkey. Materials and Methods: In this multicenter, prospective, and cross-sectional registry study, data for 968 patients with colorectal cancer from 21 centers in 7 geographic regions were analyzed. Results: Diagnosis was colon cancer in 662 (68.4%) and rectum cancer in 306 (31.6%) patients. In total, 60.9% of patients was male; mean age was 58.9 +/- 12.6 years. Among patients, 15.0% was drinking alcohol, 17.5% was smoking, 1.5% had familial history of polyposis, 15.0% had diabetes mellitus, 1.0% had inflammatory bowel disease. Fruit and vegetable consumption was low (<3 times/week) in 35.5% and red meat consumption was high (>= 3 times/week) in 47.4% of the patients. Median time-to diagnosis was 3.0 months and 4.0 months for patients with colon and rectum cancer, respectively. Mean body mass index was >25 in all group of patients. Distal rectum (61.3%) and sigmoid colon (36.8%) were the most common locations of cancer, for rectum and colon respectively. In total, 85.6% of patients were operated; 25.8% had emergency surgery. Low anterior resection rate was 64.2% in rectum cancer. In majority (89.8%) of the patients with rectum cancer who received preoperative treatment, conventional chemo-radiotherapy regimen was given. pTNM staging at diagnosis showed that stage III and IV patients were in majority (35.9% and 29.7%, respectively). Conclusion: Colon cancer is more frequent than rectum cancer in Turkey. Colorectal cancer patients are diagnosed at later stages. Most of the cases were operated. Interregional differences for risk factors are worthwhile for evaluation in future trials.Item Perspectives and Practical Applications of Medical Oncologists on Defensive Medicine (SYSIPHUS study): A Study of the Palliative Care Working Committee of the Turkish Oncology Group (TOG)(2015) Tanriverdi, Ozgur; Cay-Senler, Filiz; Yavuzsen, Tugba; Turhal, Serdar; Akman, Tulay; Komurcu, Seref; Cehreli, Ruksan; Ozyilkan, Ozgur; 0000-0001-8825-4918; 25750041; AAD-2817-2021Defensive medicine occasionally indulges unnecessary treatment requests to defend against lawsuits for medical errors and the use of unapproved medical applications. This study determines the attitudes and orientations of medical oncologists on defensive medicine. A cross-sectional survey was sent by e-mail to medical oncologists. The survey was designed to determine the participants' demographic characteristics and defensive medicine practices. The survey measured the attitudes about defensive medicine practices of the oncologists based on a five-point Likert scale (never, rarely, sometimes, often, and always). One hundred and forty-six of a total of 402 physicians serving in oncology were fully filled, and the rate of return invitation was 36 %. The majority of participants were male, with a duration of between 7 and 9 years of work as university hospital officials, and the mean age was 46 +/- 9 (years). International guidelines were followed in the most common is NCCN, and the majority of respondents felt that the application of these guidelines improves their defensive medicine. All participants of defensive medicine who stand on the basis of the definition were found to be more afraid of complaints by patients' relatives. Physicians of 45 % was noted that applying defensive medicine. Among the participants were the most frequent checkups of positive defensive approach is defined as increasing or shortening the follow-up period, while avoiding high-risk patients were detected as described in the definition of negative defensive medicine. Both professional groups in both the positive and negative defensive medicine approach defensive medicine approach, academic tasks, work experience and job time, there was a significant correlation between the location. Made in single-and multivariable analyses, positions were identified both positive and negative defensive medicine is an independent risk factor for direction. Improving the working conditions of young physicians to protect against medical error may require additional educational opportunities.Item Geographic Variations of Clinical Characteristics in Breast Cancer: Analysis of Turkish National Breast Cancer Registry(2015) Kilickap, Saadettin; Altundag, Kadri; Dumanli, Esra; Gumus, Mahmut; Uslu, Ruchan; Ozyilkan, Ozgur; Yalcin, Bulent; Kara, Oguz; Dogu, Gamze Gokoz; Ozturk, Banu; Kaya, Ali Osman; Aliustaoglu, Mehmet; Uncu, Dogan; Ozdemir, Feyyaz; Cicin, Irfan; Ozkan, Metin; Kocer, Murat; Turna, Hande; Buyukberber, Suleyman; Benekli, Mustafa; Coskun, Ugur; Karaoglu, Aziz; Tekin, Salim Basol; Dane, Faysal; Avci, Nilufer; Ulas, Arife; Oksuzoglu, Berna; Sevinc, Alper; Boruban, Melih CemItem Association of Age with Breast Cancer Clinical and Pathological Factors: Analysis of Turkish National Breast Cancer Registry(2015) Benekli, Mustafa; Altundag, Kadri; Dumanli, Esra; Isikdogan, Abdurrahman; Karaoglu, Aziz; Tekin, Salim Basol; Oksuzoglu, Berna; Kocer, Murat; Sevinc, Alper; Boruban, Melih Cem; Turna, Hande; Uslu, Ruchan; Ozyilkan, Ozgur; Yalcin, Bulent; Coskun, Ugur; Kilickap, Saadettin; Dogu, Gamze Gokoz; Ozturk, Banu; Gumus, Mahmut; Buyukberber, Suleyman; Uncu, Dogan; Kara, Oguz; Aliustaoglu, Mehmet; Ozkan, Metin; Cicin, Irfan; Elkiran, E. Tamer; Dane, Faysal; Avci, Nilufer; Ulas, Arife; Ozdemir, Feyyaz; Kaya, Ali OsmanItem The Perspective of Non-oncologist Physicians on Patients with Metastatic Cancer and Palliative Care (ALONE Study): A Study of the Palliative Care Working Committee of the Turkish Oncology Group (TOG)(2015) Tanriverdi, Ozgur; Yavuzsen, Tugba; Akman, Tulay; Senler, Filiz Cay; Taskoylu, Burcu Yapar; Turhal, Serdar; Komurcu, Seref; Cehreli, Ruksan; Yaren, Arzu; Ozyilkan, Ozgur; 0000-0001-8825-4918; 0000-0001-9375-8133; 0000-0002-7714-5385; 0000-0002-0598-7284; 25631655; AAD-2817-2021; Q-1628-2019; F-1577-2019; M-2172-2015; AAB-7092-2022; AAI-1824-2019The aim of our study was to determine the perspective of non-oncologist physicians regarding their attitudes and beliefs associated with palliative care for patients with metastatic cancer. The study was planned as a cross-sectional survey, and non-oncologist physicians were reached via e-mail and social networking sites. The first part of the questionnaire involved demographic properties, the second part inquired as to the perspectives of participants regarding metastatic disease, and the third part was used to determine beliefs and attitudes about palliative care. All of the questions were five-point Likert-type questions. A total of 1734 physicians completed the questionnaire. The majority of participants were general surgeons or internal medicine specialists (21 and 18 %, respectively), were male (61 %), were younger than 50 years of age (54 %), worked in the town center (67 %), had more than 11 years of professional experience (57 %), and worked in a hospital without an active oncology service (86 %). A total of 71 % of participants identified all patients with metastatic cancer as being terminal stage, 62 % were unaware of palliative care techniques, 64 % did not know about common supportive care options, 59 % were against hospice, and 63 % had no opinion on resuscitation. We determined that non-oncologist physicians believed that all patients with metastatic cancer are at the terminal stage and that palliative/supportive care is the oncologist's task. These data suggest that non-oncologist physicians would benefit from additional graduate and postgraduate courses on these topics.Item Procalcitonin as A Biomarker for Infection-Related Mortality in Cancer Patients(2015) Sedef, Ali M.; Kose, Fatih; Mertsoylu, Huseyin; Ozyilkan, Ozgur; 0000-0002-0156-5973; 0000-0002-1932-9784; 0000-0001-8825-4918; 25872114; G-4827-2016; M-9530-2014; AAD-2817-2021Purpose of review Infectious diseases are the second leading cause of death following direct cancer-related complications in the field of oncology. Clinical studies using the classic inflammatory biomarkers, C-reactive protein, erythrocyte sedimentation rate, leukocytosis, and thrombocytosis fail to show a significant correlation between these biomarkers and infection-related mortality. It is therefore crucial to define new biomarkers that are not affected by the primary cancer and precisely show the severity of the infection to help in the decision-making process. Recent findings A significant increase in the number of cancer patients in the past decades has created an exponential increase in the number of immunocompromised patients. Preemptive and typically unnecessary usage of broad-spectrum antibiotics is common during the treatment of these patients and may result in an increase in multidrug-resistant microbial strains. Recent clinical studies suggest that a significant reduction in antibiotic consumption may be achieved by procalcitonin-guided algorithms without sacrificing the outcome of patients with severe infection. Summary In this article, we focus on procalcitonin and its potential role in differentiating cancer and infection-induced inflammation. Using this strategy may significantly reduce the usage of empirical broad-spectrum antibiotics and result in earlier discharge of patients.Item 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