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Öğe Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: Results of real-life experiences(Elsevier, 2021) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Artaç, Mehmet; Özhan, Nail; Akar, Emre; Çakar, Burcu; Köstek, Osman; Ekenel, Meltem; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Yılmaz, Uğur; Bilgetekin, İrem; Yıldız, Birol; Şendur, Mehmet Ali Nahit; Paksoy, Nail; Dirican, Ahmet; Erdem, Dilek; Selam, Meltem; Tanrıverdi, Özgür; Paydaş, Semra; Urakçı, Zuhat; Atağ, Elif; Güncan, Sabri; Ürün, Yüksel; Alkan, Ali; Kaya, Ali Osman; Tataroğlu Özyükseler, Deniz; Taşkaynatan, Halil; Yıldırım, Mustafa; Sönmez, Müge; Başoğlu, Tuğba; Gündüz, Şeyda; Kılıçkap, SaadettinBackground: 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.Öğe Predictive factor for lymph node metastasis in non-metastatic colorectal adenocarcinomas(Kare Publishing, 2022) Karcı, Ebru; Ürün, Yüksel; Köksoy, Elif Berna; Uçar, Gökhan; Bilgin, Burak; Yekedüz, Emre; Arslan, Çağatay; Alkan, Ali; Dede, İsa; Tuncay, Gülseren; Hocazade, Cemil; Yıldırım Özdemir, Nuriye; Şendur, Mehmet Ali Nahit; Utkan, Güngör; Yalçın, Bülent; Akbulut, HakanObjectives: To evaluate the predictive factors of lymph node involvement in non-metastatic colorectal adenocarcinomas (nmCRC). Methods: A total of 453 patients diagnosed with nmCRC were analyzed regarding T stage, lymphovascular invasion status, tumor grade and proposed risk score (RS), determined by the combination of these three factors for lymph node metastasis. Results: The median age was 62 (25-90 years), M/F ratio was 1.4:1 and majority of the patients had tumors localized on the left colon (70.6%). The number of excised lymph nodes was ?12 in 77% of the cases. The postoperative pathological assessments revealed that 57.2% of patie,nts had N0 disease, 29.1% had N1 disease, and 13.7% had N2 disease. The T stages (p=0.007), grade (p<0.001), lymphovascular invasion (p=0.002), RS (p<0.001), and number of excised lymph nodes (p=0.029) were significantly different between N0, N1, and N2 patients. Higher RS was associated with lymph node metastasis (p<0.001). Conclusion: The risk score may predict lymph node metastasis in patients with nmCRC and if validated may be helpful in the decision-making of adjuvant chemotherapy, especially in the elderly and patients with inadequate lymph node dissection.Öğe Prognostic factors in patients with metastatic urothelial carcinoma who have treated with atezolizumab(Springer Japan KK, 2021) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Özhan, Nail; Çakar, Burcu; Köstek, Osman; Ekenel, Meltem; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Bilgetekin, İrem; Yıldız, Birol; Şendur, Mehmet Ali Nahit; Paksoy, Nail; Dirican, Ahmet; Erdem, Dilek; Selam, Meltem; Tanrıverdi, Özgür; Paydaş, Semra; Urakçı, Zuhat; Atağ, Elif; Güncan, Sabri; Ürün, Yüksel; Alkan, Ali; Kaya, Ali Osman; Tataroğlu Özyükseler, Deniz; Taşkaynatan, Halil; Yıldırım, Mustafa; Sönmez, Müge; Başoğlu, Tuğba; Gündüz, Şeyda; Kılıçkap, Saadettin; Artaç, MehmetBackground 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 Utilization of injectable drugs for communicable and non-communicable diseases in primary healthcare: A retrospective study in Turkey(AVES, 2023) Tulu Çolak, Selcan; Vızdıklar, Caner; Aydın, Volkan; Dönertaş Ayaz, Başak; Alkan, Ali; Akıcı, AhmetObjective: Primary care, which is often the first level of contact for patients with various communicable diseases (CDs) and noncommunicable diseases (NCDs), might exhibit patterns of injectable drug utilization different from hospitals. We aimed to examine injection prescribing to adults with CD or NCD in primary care. Methods: In this retrospective study, single- diagnosis injectable drug-containing prescription data from Family Medicine Information System comprising 32 provinces of Turkey were analysed. The prescriptions were grouped by diagnosis as "CD" (n=3848) and "NCD" (n=9338). Injectable drug utilization patterns in these groups were analysed by demographics, diagnoses, and drug subgroups. Results: Out of 13186 prescriptions, 70.8% were issued for NCDs. NCD prescriptions were mostly generated for women and elderly (p<0.05 for both). About 63.3% (n=2948) of injectable drugs in CD prescriptions were antibiotics and 12.6% were analgesics. Cefazolin (15.2%) was the most commonly prescribed antibiotic for acute pharyngitis and acute sinusitis, and benzathine benzylpenicillin (12.8%) was the top- choice for acute tonsillitis and rheumatic fever. In NCD prescriptions, 34.0% (n=4214) of injectable agents were analgesics and 16.9% were muscle relaxants. The most frequently encountered drug in NCD prescriptions was thiocolchicoside (16.3%), which was the top-choice in all seven common musculoskeletal diagnoses. Conclusion: Muscle relaxants and analgesics were the most commonly prescribed injectable drugs for NCDs, musculoskeletal diseases in particular. Antibiotics were frequently encountered in CD prescriptions, mostly as broad-spectrum for lower respiratory tract infections (RTIs) and narrow-spectrum for upper RTIs. These findings may elucidate the issues to especially focus on regarding excessive use of injections.
