Browsing by Author "Ölmez Ö.F."

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    Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab
    (Springer Japan, 2021) Tural D.; Ölmez Ö.F.; Sümbül A.T.; Özhan N.; Çakar B.; Köstek O.; Ekenel M.; Erman M.; Coşkun H.Ş.; Selçukbiricik F.; Keskin Ö.; Türköz F.P.; Oruç K.; Bayram S.; Bilgetekin İ.; Yıldız B.; Şendur M.A.N.; Paksoy N.; Dirican A.; Erdem D.; Selam M.; Tanrıverdi Ö.; Paydaş S.; Urakçı Z.; Atağ E.; Güncan S.; Ürün Y.; Alkan A.; Kaya A.O.; Özyükseler D.T.; Taşkaynatan H.; Yıldırım M.; Sönmez M.; Başoğlu T.; Gündüz Ş.; Kılıçkap S.; Artaç M.
    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. © 2021, Japan Society of Clinical Oncology.
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    Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences
    (Elsevier B.V., 2021) Tural D.; Ölmez Ö.F.; Sümbül A.T.; Artaç M.; Özhan N.; Akar E.; Çakar B.; Köstek O.; Ekenel M.; Erman M.; Coşkun H.Ş.; Selçukbiricik F.; Keskin Ö.; Türköz F.P.; Oruç K.; Bayram S.; Yılmaz U.; Bilgetekin İ.; Yıldız B.; Şendur M.A.N.; Paksoy N.; Dirican A.; Erdem D.; Selam M.; Tanrıverdi Ö.; Paydaş S.; Urakçı Z.; Atağ E.; Güncan S.; Ürün Y.; Alkan A.; Kaya A.O.; Özyükseler D.T.; Taşkaynatan H.; Yıldırım M.; Sönmez M.; Başoğlu T.; Gündüz Ş.; Kılıçkap S.
    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 treatment 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 metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. © 2020 European Association of Urology
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    Atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer: a real-life data of the Turkish Oncology Group
    (Springer Science and Business Media Deutschland GmbH, 2022) Gürbüz M.; Kutlu Y.; Akkuş E.; Köksoy E.B.; Köse N.; Öven B.B.; Uluç B.O.; Demiray A.G.; Erdem D.; Demir B.; Turhal N.S.; Üskent N.; Akbaş S.; Selçukbiricik F.; İnal A.; Bilici A.; Ölmez Ö.F.; Çabuk D.; Ünal Ç.; Hızal M.; Şendur M.A.N.; Korkmaz M.; Karadurmuş N.; Ertürk İ.; Göksu S.S.; Tatlı A.M.; Güven D.C.; Kılıçkap S.; Paksoy N.; Aydıner A.; Çınkır H.Y.; Özkul Ö.; Öztürk A.; Ballı S.; Kemal Y.; Erdoğan A.P.; Er Ö.; Yumuk P.F.; Demirkazık A.
    Purpose: Atezolizumab has been shown to be effective and safe in randomized trial in the first-line treatment of extensive-stage small cell lung cancer (SCLC). However, there are limited real-life data on atezolizumab. In this study, we aimed to determine the real-life efficacy and safety of atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage SCLC. Methods: This trial is a retrospective multicenter study of the Turkish Oncology Group, which included extensive-stage SCLC patients who received atezolizumab combined with chemotherapy in a first-line treatment. The characteristics of the patients, treatment and response rates, and PFS and OS are presented. Factors associated with PFS and OS were analyzed by univariate and multivariate analysis. Results: A total of 213 patients at the 30 oncology centers were included. The median number of chemotherapy cycle was 5 (1–8) and atezolizumab cycle was 7 (1–32). After median 11.9 months of follow-up, median PFS and OS was 6.8 months (95%CI 5.7–7.8), and 11.9 months (95%CI 11–12.7), respectively. The ORR was 61.9%. ECOG-PS (p = 0.002) and number of metastatic sites (p = 0.001) were associated with PFS and pack-year of smoking (p = 0.05), while ECOG-PS (p = 0.03) and number of metastatic sites (p = 0.001) were associated with OS. Hematological side effects were common and toxicities were manageable. Conclusion: This real-life data confirm the efficacy and safety of atezolizumab in combination with chemotherapy in first-line treatment of extensive-stage SCLC. © 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.