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    Association of response to first-line chemotherapy with the efficacy of atezolizumab in patients with metastatic urothelial carcinoma
    (Lippincott Williams & Wilkins, 2021) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Artaç, Mehmet; Özhan, Nail; Akar, Emre; Çakar, Burcu; Köstek, Osman; Ekenel, Meltem; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Yılmaz, Uğur; Bilgetekin, İrem; Yıldız, Birol; Şendur, Mehmet Ali Nahit; Erman, Mustafa
    Background: In the current study, we evaluated whether the response first-line chemotherapy could impact atezolizumab benefit in terms of response rate and overall survival in patients with metastatic urothelial carcinoma. Methods: In this study, we present the retrospective analysis of 105 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. The association between response to first-line chemotherapy and ATZ was assessed using Fisher’s exact test. Overall survival (OS) was estimated by using the Kaplan-Meier method. 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 the final model if p?0.05. Results: Best response to first-line chemotherapy was complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in 5(4.8%), 38(36.2%), 16(15.2%), 46(43.8%) patients, respectively. Best response to atezolizumab was CR, PR, SD, PD in 9(8.6%), 22(21%), 23(21,9%), 51(48,5%). Forty (74.1%) of patients who benefited from first-line chemotherapy also benefited from atezolizumab, while only 14 (25.9%) of patients with initial PD after first-line chemotherapy subsequently experienced clinical benefit with atezolizumab (Fisher’s exact test, p=0.001). Patients with clinical benefit from first-line chemotherapy had a higher OS. The median OS of atezolizumab were 14.8 and 3.4 months for patients with clinical benefit and progressive disease in response to first-line chemotherapy, respectively (log-rank p=0.001). In univariate analysis, Patients with clinical benefit from first-line chemotherapy, 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 significantly associated with OS. Three of the adverse prognostic factors according to the Bellmunt criteria were independent factor of short survival: liver metastases (Hazard Ratio [HR]= 0.6; 95% CI 0.174-0.60; p=0.04), ECOG PS?1 (HR= 0.36; 95% CI 0.2-0.66; p=0.001), and Hemoglobin level below 10 mg/dl (HR= 0.36; 95% CI 0.2-0.66; p <0.001). In addition, Patients with clinical benefit from first-line chemotherapy (HR= 0.39; 95% CI 0.24-0.65; p <0.001) maintained a significant association with OS in multivariate analysis. Conclusions: Our study demonstrated that clinical benefit from first-line chemotherapy was independent prognostic factor on OS in patients' use of atezolizumab as second-line treatment in metastatic bladder cancer. Furthermore, these findings are important for stratification factors for future immunotherapy study design in patients with bladder cancer who have progressed after first-line chemotherapy.
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    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, Saadettin
    Background: 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.
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    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, Mehmet
    Background 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.