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Öğe Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: Results of real-life experience(Amer Soc Clinical Oncology, 2020) Tural, Deniz; Olmez, Omer Fatih; Sumbul, Ahmet Taner; Artac, Mehmet; Ozhan, Nail; Akar, Emre; Cakar, Burcu[Abstract Not Availabe]Öğe Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences(Elsevier, 2021) Tural, Deniz; Olmez, Omer Fatih; Sumbul, Ahmet Taner; Artac, Mehmet; Ozhan, Nail; Akar, Emre; Cakar, BurcuBackground: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum resistant urothelial carcinoma. Objective: To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Design, setting, and participants: Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. Outcome measurements and statistical analysis: The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Results and limitations: Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47-28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25-5.49) and 9.8 mo (95% CI, 6.7-12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3-4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treat-ment response based on clinical notes and local radiographic studies. Conclusions: In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Patient summary: Atezolizumab is effective and well-tolerated in patients with meta-static urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.Öğe Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab(Springer Japan Kk, 2021) Tural, Deniz; Olmez, Omer Fatih; Sumbul, Ahmet Taner; Ozhan, Nail; Cakar, Burcu; Kostek, Osman; Ekenel, MeltemBackground Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies of patients with metastatic platinum-resistant urothelial carcinoma. However, the response rate of Atezolizumab was modest. In the current study, we evaluated the pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy in the Expanded-Access Program of Atezolizumab. Patients and methods In this study, we present a retrospective analysis of 113 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. Data of the patients was obtained from patient files and hospital records. Eligible patients included metastatic urothelial carcinoma patients treated with at least one course of ATZ. Univariate analysis was used to identify clinical and laboratory factors that significantly impact OS. Variables were retained for multivariate analysis if they had a statistical relationship with OS (p < 0.1), and then included a final model of p < 0.05. Results The median follow-up duration was 23.5 months. Of the patients, 98 (86.7%) were male and 13.3% were female. The median age was 65 years of age (37-86). In univariate analysis, primary tumor location in the upper tract, increasing absolute neutrophil count (ANC), increasing absolute lymphocyte count, neutrophil-to-lymphocyte ratio (NLR) > 3, liver metastases, baseline creatinine clearance less (GFR) than 60 ml/min, Eastern Cooperative Oncology Group (ECOG) performance status (1 >=), and hemoglobin levels below 10 mg/dl were all the significantly associated with OS. Three of the five adverse prognostic factors according to the Bellmunt criteria were independent of short survival: liver metastases HR 3.105; 95% CI 1.673-5.761; p < (0.001), ECOG PS (1 >=) HR 2.184; 95% CI 1.120-4.256; p = 0.022, and Hemoglobin level below 10 mg/dl HR 2.680; 95% CI 1.558-4.608; p < (0.001). In addition, NLR > 3 hazard ratio [HR] 2.092; 95% CI 1.031-4.243; p = 0.041 and GFR less than 60 ml/min HR 1.829; 95% CI 1.1-3.041; p = 0.02, maintained a significant association with OS in multivariate analysis. Conclusions This model confirms the Bellmunt model with the addition of NLR > 3 and GFR less than 60 ml/min and can be associated with clinical trials that use immunotherapy in patients with bladder cancer.Öğe The Relationship of Red-Cell Distribution Width and Carotid Intima Media in Chronic Kidney Disease(Turk Nefroloji Diyaliz Transplantasyon Dergisi, 2016) Guclu, Aydin; Tokmak, Turgut Tursem; Kaymaz, Haci; Turkmen, Kultigin; Senol, Hande; Ozhan, Nail; Dursun, YusufOBJECTIVE: Red-cell distribution width (RDW) is a parameter routinely used for diagnosis of different anemia types. Recent studies have shown the RDW relationship with mortality in general population and patients with cardiovascular disease. However, the number of studies on RDW in chronic kidney disease (CKD) is insufficient. We evaluated the relationship between RDW and carotid intima media thickness (IMT), which is a predictor of atherosclerosis, in patients with CKD. MATERIAL and METHODS: 30 healthy controls, 30 patients with CKD, 37 hemodialysis patients were included. IMT was measured with ultrasonography. RESULTS: We identified statistically significant differences in CRP (p: 0.039), hemoglobin (p< 0.001), IMK (p< 0.001), RDW (p< 0.001), urea (p< 0.001), creatinine (p< 0.001), albumin (p< 0.001), uric acid (p< 0.001) and ferritin (p< 0.001) levels among three groups. In post hoc analysis, the IMK value was statistically significantly higher in the predialysis (p< 0.001) and hemodialysis group than healthy controls. IMK value was not statistically different in the hemodialysis group than the predialysis group (p: 0.988). The RDW value was higher in the predialysis group than controls with a trend to statistical significance (p: 0.067). RDW value showed positive correlation with IMK (r: 0.356 P: 0.012) and CRP (r: 0.361 P: 0.004). CONCLUSION: RDW is associated with inflammation and intima media thickness in patients with CKD.
