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Öğe Bevacizumab plus Capecitabine as Maintenance Therapy after Initial Bevacizumab plus XELOX Treatment in Previously Untreated Patients with Metastatic Colorectal Cancer: Phase Ill 'Stop and Go' Study Results - A Turkish Oncology Group Trial(Karger, 2013) Yalcin, Suayib; Uslu, Ruchan; Dane, Faysal; Yilmaz, Ugur; Zengin, Nurullah; Buyukunal, Evin; Buyukberber, Suleyman; Camci, Celalettin; Sencan, Orhan; Kilickap, Sadettin; Ozdener, Fatih; Cevik, DuyguObjective: It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin (XELOX) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer (mCRC). Methods: Patients received either bevacizumab (7.5 mg/kg) + XELOX (capecitabine 1,000 mg/m(2) twice daily on days 1-14 + oxaliplatin 130 mg/m2 on day 1 every 3 weeks) until disease progression (arm A) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression (arm B). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR) and safety. Results: One hundred and twenty-three patients were randomized. Treatment compliance was similar in both groups. Median PFS was significantly longer for arm B than for arm A (11.0 vs. 8.3 months; p = 0.002). There was no significant difference between the two arms for ORR (66.7 vs. 59.0%; p = 0.861) or median OS (23.8 vs. 20.2 months; p = 0.100). Tolerability was acceptable in both treatment arms; the most frequent grade 3/4 treatment-related adverse events (arm B vs. arm A) were fatigue (6.6 vs. 16.1%), diarrhoea (3.3 vs. 11.3%), anorexia (3.3 vs. 11.3%), and neuropathy (1.6 vs. 8.1%). Conclusions: Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizunnab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX. (C) 2013 S. Karger AG, BaselÖğe Gastroenteropancreatic neuroendocrine tumors: recommendations of Turkish multidisciplinary neuroendocrine tumor study group on diagnosis, treatment and follow-up(Termedia Publishing House Ltd, 2017) Yalcin, Suayib; Bayram, Fahri; Erdamar, Sibel; Kucuk, Oztem; Oruc, Nevin; Coker, AhmetGastroenteropancreatic neuroendocrine tumors (GEPNETs) are a relatively rare, heterogeneous group of diseases in which important advances have been observed in the diagnosis and treatment as well as in our understanding of the biology and genetics of the disease in recent years. Given the insufficient scientific data available on evidence-based management of GEPNETs and the differences in circumstances in individual countries, a multidisciplinary study group was established to provide guidelines for the management of GEPNETS. This study group consisted of a medical oncologist, endocrinologist, surgeon, pathologist, gastroenterologist, and a nuclear medicine specialist, who aimed to prepare a practical guide in the light of existing scientific data and international guidelines, to be used in common clinical practice.Öğe Impact of Adjuvant Chemoradiotherapy for Rectal Cancer on the Long-Term Quality of Life and Late Side Effects: A Multicentric Clinical Evaluation by the Turkish Oncology Group(Asian Pacific Organization Cancer Prevention, 2012) Kilic, Diclehan; Yalman, Deniz; Aksu, Gorkem; Atasoy, Beste M.; Igdem, Sefik; Dincbas, Fazilet O.; Yalcin, SuayibAim: Although preoperative chemoradiatherapy (CRT) has proven its benefits in terms of decreased toxicity, there is still a considerable amount of cases that do not receive postoperative CRT. Oncologists at different geographic locations still need to know the long-term effects of this treatment in order to manage patients successfully. The current paper reports on long-term quality of life (QOL) and late side effects after adjuvant CRT in rectal cancer patients from 5 centers in Anatolia. Methods: Rectal cancer patients treated with postoperative CRT with minimum 1-year follow-up and were in complete remission, were evaluated according to RTOG and LENT-SOMA scales. They were also asked to complete Turkish version of EORTC QLQ-C30 questionnaire and the CR-38 module. Each center participated with the required clinical data. Results: Two hundred and thirty patients with median age of 55 years participated and completed the study. Median follow-up time was 5 years. All patients received RT concomitant with chemotherapy. Common parameters that both increased functional health scales and yielded better symptom scores were long term interval after treatment and sphincter-saving surgery. In addition, surgery type and follow-up time were determined to be predictors of QOL scores and late toxicity grade. Conclusion: Postoperative CRT was found to have a great impact on the long term QOL and side effects in rectal cancer survivors. The factors that adversely affect these are abdominoperineal resection and shorter interval. The findings may encourage life-long follow-up and cooperation with patients, which should be mentioned during the initial counseling.Öğe Modified IPCW model: A method for adjusting for bias in the estimation of overall survival due to the use of second and third line therapies in locally advanced or metastatic pancreatic cancer patients.(Amer Soc Clinical Oncology, 2017) Escobar, N. E. Iznaga; Luaces, Patricia Lorenzo; Valdes, Lizet Sanchez; Silva, Carmen Valenzuela; Ramos, Tania Crombet; Strumberg, Dirk; Schultheis, Beate; Ebert, Matthias Philip; Kerkhoff, Andrea; Hofheinz, Ralf; Behringer, Dirk M.; Schmidt, Wolfgang E.; Goker, Erdem; De Doss, Sara; Kneba, Michael; Yalcin, Suayib; Overkamp, Friedrich; Schlegel, Frank; MarkusÖğe A national, multicenter, non-interventional, observational study on treatment patterns in patients with metastatic renal cell carcinoma in Turkey - NOTES study(Dove Medical Press Ltd, 2018) Yalcin, Suayib; Yildiz, Ramazan; Dane, Faysal; Karaoglu, Aziz; Oksuzoglu, Berna; Ozyilkan, Ozgur; Sevinc, Alper; Ozdemir, Feyyaz; Turna, Hande; Uslu, Ruchan; Ulay, EsatIntroduction: The introduction of targeted therapies in renal cell carcinoma has significantly improved its prognosis and treatment outcomes in recent years. Such treatment options are targeted therapies of the vascular endothelial growth factor (VEGF) pathway and the mammalian target of the rapamycin pathway. With the use of tyrosine kinase inhibitors (TKIs) and mammalian target of the rapamycin inhibitors, overall survival has increased up to 2 years. In Turkey, due to applicable reimbursement conditions for patients with metastatic renal cell carcinoma (mRCC), interferon use is mandated as a first-line treatment, thus providing information on the use of everolimus only after initial interferon and second-line VEGF-targeted treatments such as VEGF-TKI. Patients and methods: To provide a first real-life data set in Turkey, we conducted a prospective, non-interventional, observational study and assessed the efficacy and safety of everolimus after two lines of treatment including interferon. A total of 100 patients with histologically confirmed mRCC were enrolled in the study from 11 centers between June 2012 and March 2014 (70 males and 30 females). Efficacy was assessed on the basis of progression-free survival and overall survival; safety of everolimus was assessed on the basis of adverse event occurrence. Results: The study results showed that the median progression-free survival with everolimus treatment was 8.1 months (95% CI: 5.1-11.1) and the median overall survival was 17.6 months (95% CI: 10.1-25.1), thus indicating a better overall response based on survival durations than those from the randomized Phase III REnal Cell cancer treatment with Oral RAD001 given Daily study results (4.9 and 14.8 months, respectively). Conclusion: The study showed that everolimus treatment is a safe and effective treatment option in the treatment of mRCC after VEGF-TKI, with an acceptable safety and tolerability profile in real-life settings.Öğe Nutritional Aspect of Cancer Care in Medical Oncology Patients(Elsevier, 2019) Yalcin, Suayib; Gumus, Mahmut; Oksuzoglu, Berna; Ozdemir, Feyyaz; Evrensel, Turkkan; Sarioglu, Aysugul Alptekin; Goker, ErdemPurpose: Awareness of advances in the nutritional aspects of cancer care and translation of this information into clinical practice are important for oncology practitioners to effectively couple oncologic and nutritional approaches throughout the cancer journey. the goal of this consensus statement by a panel of medical oncologists was to provide practical and implementable guidance addressing nutritional aspects of cancer care from the perspective of the medical oncologist. Methods: A panel of medical oncologists agreed on a series of statements supported by scientific evidence and expert clinical opinion. Findings: Participating experts emphasized that both poor nutritional intake and metabolic alterations underlie cancer-related malnutrition. the use of liquid and high energy-dense oral nutritional supplements may enable better patient compliance, whereas higher efficacy is more likely with the use of pharmaconutrient-enriched oral nutritional supplements in terms of improved weight, lean body mass, functional status, and quality of life, as well as better tolerance to antineoplastic treatment. A multimodal approach is currently believed to be the best option to counteract the catabolism leading to cancer-related malnutrition; this treatment is scheduled in parallel with anticancer therapies and includes nutritional interventions, multitarget drug therapies, and exercise and rehabilitation programs. Participating experts emphasized the role of the oncologist as a reference professional figure in the coordination of nutritional care for patients with cancer within the context of complex and different clinical scenarios, particularly for permissive-adjunctive nutritional support. (C) 2019 the Authors. Published by Elsevier Inc.Öğe A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study) A Turkish Oncology Group Study(Lippincott Williams & Wilkins, 2021) Abali, Huseyin; Yalcin, Suayib; Onal, Huseyin C.; Dane, Faysal; Oksuzoglu, Berna; Ozdemir, Nuriye; Mertsoylu, HuseyinBackground: Trastuzumab prolonged the overall survival in patients with advanced gastric cancer with human epidermal growth factor receptor 2 (HER2) overexpression in combination with chemotherapy. In this phase II open-label prospective study, the tolerability and safety of trastuzumab with chemotherapy, and chemoradiotherapy for curatively resected patients with HER2-positive gastric carcinoma was investigated. Methods: The patients with HER2-positive gastric, or gastroesophageal junction adenocarcinoma, after gastrectomy plus D2 dissection, were included. They received 3 cycles of oxaliplatin (100 mg/m(2) intravenously day 1) plus capecitabine (850 mg/m(2) orally days 1 to 14), trastuzumab (8 mg/kg intravenously day 1 in cycle 1, 6 mg/kg thereafter) every 21 days, followed by chemoradiotherapy. Trastuzumab was given for 1 year. Results: Of the 212 patients screened, 35 were eligible, and 34 were treated. The median age was 56 years (minimum to maximum: 35 to 75 y), male patients constituted 73.5% (n=25), and 33 (97.1%) had gastric adenocarcinoma. R0 resection was performed in 30 (88.2%). The majority (26, 61.7%) were in stage III disease. Most of the adverse events were grade I/II, the most frequent grade III side effects were nausea (3, 8.8%), vomiting (3, 8.8%), diarrhea (2, 5.9%), and weight loss (n=2, 5.9%). Two patients died during the first 3 cycles of chemotherapy and chemoradiotherapy; 1 secondary to pulmonary thromboembolism, and the other due to cerebral ischemia. After excluding 2 with early progression and 1 consent withdrawal, of the remaining 31 patients, 28 (90.3%) were able to complete the chemotherapy and chemoradiotherapy part of the trial. After the 25 months follow-up period, 21 patients (61.8%) were alive. Overall survival at 12 and 24 months was 75.0% and 58.0%, while disease-free survival at 12 and 24 months was 65.7% and 55.0%, respectively. Conclusions: Trastuzumab in combination with capecitabine, oxaliplatin following chemoradiotherapy as the adjuvant therapy for gastric or gastroesophageal junction adenocarcinoma was considered as safe and tolerable. The frequency of HER2 overexpression in curatively resected patients is comparable to that in patients with metastatic diseaseÖğe Phase II, randomized, double-blind placebo-controlled trial of nimotuzumab plus gemcitabine compared with gemcitabine alone in patients (pts) with advanced pancreatic cancer (PC)(Amer Soc Clinical Oncology, 2013) Strumberg, Dirk; Schultheis, Beate; Ebert, Matthias Philip; Kerkhoff, A.; Hofheinz, Ralf Dieter; Behringer, Dirk M.; Schmidt, Wolfgang E.; Goker, Erdem; De Dosso, Sara; Kneba, Michael; Yalcin, Suayib; Overkamp, Friedrich; Schlegel, Frank; Dommach, M.; Rohrberg, Robert; Steinmetz, Tilman; Reuter, Dirk; Bach, FerdinandÖğe Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial(Springer, 2009) Curran, Desmond; Pozzo, Carmelo; Zaluski, Jerzy; Dank, Magdalena; Barone, Carlo; Valvere, Vahur; Yalcin, Suayib; Peschel, Christian; Wenczl, Miklos; Goker, Erdem; Bugat, RolandThe quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented. Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling. A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm. There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.Öğe Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial(Springer, 2009) Curran, Desmond; Pozzo, Carmelo; Zaluski, Jerzy; Dank, Magdalena; Barone, Carlo; Valvere, Vahur; Yalcin, Suayib; Peschel, Christian; Wenczl, Miklos; Goker, Erdem; Bugat, RolandThe quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented. Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling. A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm. There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.Öğe Quality of life study in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel versus gemcitabine alone:ax-panc-sy001: A phase II randomized study.(Amer Soc Clinical Oncology, 2018) Yalcin, Suayib; Dane, Faysal; Oksuzoglu, Berna; Yildirim, Nuriye; Isikdogan, Abdurrahman; Ozkan, Metin; Demirag, Guzin; Coskun, Hasan Senol; Karabulut, Bulent; Evrensel, Turkkan; Ustaoglu, Mehmet Ali; Ozdemir, Feyyaz; Turna, Hande; Yavuzsen, Tugba; Aykan, Faruk; Sevinc, Alper; Akbulut, Hakan; Yuce, Deniz; Hayran, Mutlu; Kilickap, SaadettinÖğe Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine plus nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study(Bmc, 2020) Yalcin, Suayib; Dane, Faysal; Oksuzoglu, Berna; Ozdemir, Nuriye Yildirim; Isikdogan, Abdurrahman; Ozkan, Metin; Kilickap, SaadettinBackgroundCombination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown.MethodsA total of 125 patients were randomized to combination therapy (1000mg/m2 gemcitabine +125mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000mg/m2) arms to take treatment weekly for 7 of 8weeks, and following 3 of 4weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.ResultsOverall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p=0.018). These proportions were 27.3 and 36.6% in 6(th) month assessments, respectively (p=0.357). Median overall survivals in combination and single-agent arms were 9.92months and 5.95months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p=0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p=0.008). Median time-to-deterioration were 5.36 vs 3.68months, and objective response rates were 37.1% vs 23.7% (p=0.009), respectively in combination and single-agent arms.ConclusionsCombination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer.Trial registrationThis study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).Öğe Renal cell cancer: overview of the current therapeutic landscape(Taylor & Francis Ltd, 2016) Erman, Mustafa; Benekli, Mustafa; Basaran, Mert; Bavbek, Sevil; Buyukberber, Suleyman; Coskun, Ugur; Demir, Gokhan; Karabulut, Bulent; Oksuzoglu, Berna; Ozkan, Metin; Sevinc, Alper; Yalcin, SuayibIntroduction: The last decade has witnessed dramatic improvements in the diagnosis, classification and treatment of renal cell cancer (RCC). Besides improvements in surgical techniques in early stages, introduction of novel targeted agents has resulted in improved outcomes in advanced RCC for which no effective treatment existed until recently.Areas covered: This article reviews epidemiology, pathology and pathogenesis, diagnosis, clinical staging, prognostic factors and treatment modalities of early stage and advanced RCC.Expert commentary: Although treatment options are expanding rapidly, practicing physicians face considerable challenges in the decision-making process. Therapeutic agents may have unique side effects and unexpected drug interactions. RCC represents one of the major success stories of clinical oncology in recent years and the progress appears to be far from having reached a plateau. We aim to present a comprehensive in-depth review of RCC in an attempt to provide evidence-based recommendations and future perspectives for practicing oncologists.Öğe Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study(Bmj Publishing Group, 2020) Dane, Faysal; Ozgurdal, Kirhan; Yalcin, Suayib; Benekli, Mustafa; Aykan, Nuri Faruk; Yucel, Idris; Yumuk, Perran FuldenObjectives Regorafenib improved overall survival in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies in two randomised, phase III trials, but has not been evaluated in Turkey. REGARD evaluated the safety and efficacy of regorafenib in Turkish patients with treatment-refractory mCRC. Design Open-label, single-arm, phase IIIb study conducted between July 2013 and April 2015. Setting 11 tertiary centres in Turkey. Participants Eligible patients were adults with mCRC who had disease progression within 3 months after receiving their last dose of approved standard therapies and who had an Eastern Cooperative Oncology Group performance status <= 1. Patients were excluded if they had previously received regorafenib. of 139 patients screened, 100 were treated and completed the study, and all 100 were analysed. Fifty-eight per cent were male. Interventions Patients received oral regorafenib, 160 mg once daily, for the first 3 weeks of each 4-week cycle until disease progression, death or unacceptable toxicity. Primary and secondary outcome measures the primary endpoint was safety, assessed by incidence of treatment-emergent adverse events (TEAEs). Progression-free survival (PFS) per investigator was the primary efficacy endpoint. There were no secondary endpoints. Results the median treatment duration was 2.5 months (range 0.1 to 20.6). Ninety-six per cent of patients had at least one TEAE and 77% had a grade >= 3 TEAE. the most common grade >= 3 regorafenib-related TEAEs were hypophosphataemia (11%), fatigue (8%), hyperbilirubinaemia (6%), hand-foot skin reaction (5%), hypertension (5%), anorexia (5%) and increased alanine aminotransferase (5%). TEAEs led to dose reduction in 30% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 17% of patients. Median PFS was 3.1 months (95% CI 2.9 to 3.8). Conclusion the regorafenib safety profile and PFS in REGARD were consistent with the results of previous trials of regorafenib in mCRC. Regorafenib is an option for patients in Turkey with treatment-refractory mCRC.Öğe A study of the combination of oxaliplatin, capecitabine, and herceptin (trastuzumab) and chemoradiotherapy in the adjuvant setting in operated patients with HER2+gastric or gastro-esophageal junction cancer (TOXAG study).(Amer Soc Clinical Oncology, 2016) Abali, Huseyin; Yalcin, Suayib; Onal, Huseyin Cem; Dane, Faysal; Oksuzoglu, Berna; Ozdemir, Nuriye; Mertsoylu, Huseyin; Artac, Mehmet; Camci, Celalettin; Karabulut, Bulent; Basal, Fatma Bugdayci; Budakoglu, Burcin; Sendur, Mehmet Ali Nahit; Goktas, Burce; Ozdener, Fatih; Calisgan, ArzuÖğe A study of the combination of oxaliplatin, capecitabine, and trastuzumab and chemo-radiotherapy in the adjuvant setting in operated patients with HER2+gastric or gastroesophageal junction cancer (TOXAG study).(Amer Soc Clinical Oncology, 2018) Abali, Huseyin; Yalcin, Suayib; Onal, Cem; Dane, Faysal; Oksuzoglu, Berna; Ozdemir, Nuriye; Mertsoylu, Huseyin; Artac, Mehmet; Camci, Celaletdin; Karabulut, Bulent; Basal, Fatma Bugdayci; Budakoglu, Burcin; Sendur, Mehmet Ali Nahit; Goktas, Burce; Ozdener, Fatih; Baygul, ArzuÖğe Surgical, pathological and clinical features of advanced collorectal cancers with metastasectomy. Onco-Colon Turkey Registry real-life data(Lippincott Williams & Wilkins, 2022) Karadurmus, Nuri; Yildirim, Emre; Yalcin, Suayib; Gumus, Mahmut; Bilir, Cemil; Cubukcu, Erdem; Simsek, Eda Tanrikulu[No Abstract Available]
