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Item Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab(2021) Sumbul, Ahmet Taner; 34023933Background 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.Item Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences(2021) Sumbul, Ahmet Taner; 0000-0002-5573-906X; 33008789; D-4793-2014Background: 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.Item Concurrent versus sandwich treatment in adjuvant treatment in high risk operated gastric cancer: A single center experience(2020) Sezer, Ahmet; Akkus, Berna; Guler, Ozan Cem; Onal, Huseyin Cem; Sumbul, Ahmet Taner; 0000-0001-6908-3412; 0000-0002-2742-9021; 33277854; AAC-5654-2020; D-5195-2014Purpose: In this study we compared postoperative early vs sandwich chemoradiotherapy in operated stage IIA-IIIC gastric cancer patients in terms of effectiveness and outcome. Methods: The data of 201 gastric cancer patients treated in the same center between December 2006 and June 2017 were retrospectively evaluated. One hundred forty nine patients who were eligible for the study criteria were divided into two groups according to the postoperative treatment modality. The first group included 85 patients who were given chemoradiotherapy simultaneously (ETG) and the second group icluded 64 patients who received sandwich (chemotherapychemoradiotherapy-chemotherapy) (STG) treatment. Overall survival (OS) and disease-free survival (DFS) were evaluated as primary endpoints. Results: The median follow-up time for all patient groups was 26.7 months (1.3-136.5 months). Adjuvant chemotherapy and radiotherapy were initiated concurrently in patients receiving concomitant therapy. Half of the planned chemotherapy, then chemoradiotherapy and then the remaining chemotherapy treatments were given to the sandwich treatment group. A total of 50.4 Gy radiotherapy was given to the concurrent chemoradiotherapy group and a total of 45 Gy radiotherapy to the group receiving the sandwich treatment. OS was 30.6 months (23.7-37.5) in all groups, 30.4 months (23.7-35.0) in concurrent therapy (ETG) and 35.6 months (26.3-45) in sandwich therapy (STG) (p=0.73). DFS was 26.6 months (21.3-32.0) in all groups and 24.5 months (18.1-31.0) in the group receiving ETG, 32.5 months (22.242.8) in STG. (p=0.46). The most common grade 3 and above toxicities were; acute upper gastrointestinal toxicity (19.1% in ETG vs. 9.0% in STG, p=0.01) and hematological toxicity (31.8% in ETG vs. 13.9% in STG; p=0.002). Early cessation of treatment was similar in both groups. In multivariate analysis, female gender (p=0.01), stage III disease, grade III disease were seen as negative predictive factors for overall survival. In DFS multivariate analysis, there was no difference between the groups in terms of gender, T stage, N stage, and AJCC stage. Conclusion: In this study, superiority of sandwich treatment over concurrent treatment was observed in patients with operated stage IIB-IIIC gastric cancer, but the difference was not statistically significant. If this study is performed in larger patient series, the difference of sandwich treatment may become meaningful.Item The hematologic parameters in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate(2019) Onal, Cem; Sedef, Ali Murat; Kose, Fatih; Oymak, Ezgi; Guler, Ozan Cem; Sumbul, Ahmet Taner; Aksoy, Sercan; Yildirim, Berna Akkus; Besen, Ali Ayberk; Muallaoglu, Sadik; Mertsoylu, Huseyin; Ozyigit, Gokhan; 0000-0001-6908-3412; 0000-0002-5573-906X; 0000-0002-0156-5973; 30977383; D-4793-2014; AAC-5654-2020Currently, there are no predictive markers of response to abiraterone. We calculated neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) at baseline and at 4 and 12 weeks after initiation of abiraterone, and we evaluated prostate-specific antigen (PSA) response every 4 weeks in 102 metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone either pre-or postchemotherapy. With a median follow-up was 24.0 months (range: 0.3-54.9), median overall survival (OS) was 20.8 months. High-NLR patients who remained high or who returned to low NLR after 4 and 12 weeks showed significantly worse OS than patients with low baseline NLR. NLR and prostate-specific antigen response to abiraterone was a significant predictor of OS and progression-free survival (PFS) in metastatic castration-resistant prostate cancer patients treated with abiraterone delivered either pre-or postchemotherapy.Item The outcome of loco-regional radiotherapy in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate.(2019) Yildirim, Berna; Cem, Onal; Kose, Fatih; Oymak, Ezgi; Sedef, Ali Murat; Besen, Ali Ayberk; Aksoy, Sercan; Guler, Ozan Cem; Sumbul, Ahmet Taner; Mertsoylu, Huseyin; Ozyigit, Gokhan; 0000-0001-6908-3412; D-4793-2014; AAC-5654-2020Item The hematologic parameters in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate.(2019) Cem, Onal; Sedef, Ali Murat; Kose, Fatih; Oymak, Ezgi; Guler, Ozan Cem; Sumbul, Ahmet Taner; Aksoy, Sercan; Yildirim, Berna Akkus; Besen, Ali Ayberk; Mullaoglu, Sadik; Mertsoylu, Huseyin; Ozyigit, Gokhan; 0000-0001-6908-3412; D-4793-2014; AAC-5654-2020Item Outcome of loco-regional radiotherapy in metastatic castration-resistant prostate cancer patients treated with abiraterone acetate(2019) Yildirim, Berna Akkus; Onal, Cem; Kose, Fatih; Oymak, Ezgi; Sedef, Ali Murat; Besen, Ali Ayberk; Aksoy, Sercan; Guler, Ozan Cem; Sumbul, Ahmet Taner; Mualloglu, Sadik; Mertsoylu, Huseyin; Ozyigit, Gokhan; 30701292Purpose To evaluate the potential benefit of curative radiotherapy (RT) to the primary tumor in metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone. Materials and methods The clinical parameters of 106 mCRPC patients treated with abiraterone were retrospectively evaluated. Patients were either oligometastatic (<= 5 metastases) at diagnosis or became oligometastatic after the systemic treatment was analyzed. Local RT to the primary tumor and pelvic lymphatics was delivered in 44 patients (41%), and 62 patients (59%) did not have RT to the primary tumor. After propensity match analysis, a total of 92 patients were analyzed. Resultsn Median follow-up time was 14.2 months (range: 2.3-54.9 months). Median overall survival (OS) was higher in patients treated with local RT to the primary tumor than in those treated without local RT with borderline significance (24.1 vs. 21.4 months; p=0.08). Local RT to the prostate and pelvic lymphatics significantly diminished the local recurrence rate (16 patients, 31% vs. 2 patients, 5%; p=0.003). In multivariate analysis, the prostate specific antigen (PSA) response >= 50% of the baseline obtained 3 weeks after abiraterone therapy was the only significant prognostic factor for better OS and progression-free survival (PFS). Patients treated with primary RT to the prostate had significantly less progression under abiraterone and a longer abiraterone period than those treated without local prostate RT. Conclusions Local prostate RT significantly improved OS and local control in mCRPC patients treated with abiraterone. The patients treated with primary RT had significantly less progression under abiraterone and a longer abiraterone period than those treated without local prostate RT.