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Öğe 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, MustafaBackground: 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.Öğe Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: Results of real-life experience(American Society of Clinical Oncology, 2020) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Artaç, Mehmet; Özhan, Nail; Akar, Emre; Çakar, Burcu; Köstek, Osman; Paksoy, Nail; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Yılmaz, Uğur; Bilgetekin, İrem; Yıldız, Birol; Kılıçkap, Saadettin[Abstract Not Available]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 Comparison of objective response rate and long-term overall survival in patients with treated immune checkpoint inhibitors in metastatic urothelial carcinoma.(Lippincott Williams & Wilkins, 2023) Tural, Deniz; Arslan, Çağatay; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Akar, Emre; Erman, Mustafa; Ürün, Yüksel; Erdem, Dilek; Kılıçkap, Saadettin[Abstract Not Available]Öğe Five-year outcome and safety in patients treated with immune checkpoint blockade therapies for urothelial carcinoma: Experience from real-world clinical practice(CIG Media Group, 2023) Tural, Deniz; Arslan, Çağatay; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Akar, Emre; Erman, Mustafa; Ürün, Yüksel; Erdem, Dilek; Karadurmuş, Nuri; Kılıçkap, SaadettinThis 5-year analysis of real-world data confirms the durable response and long-term survival with ICTs in a broader range of patients with metastatic urothelial carcinoma. After 24 months, PFS and OS curves remained nearly flat. The safety profile was consistent with previous reports, and no new safety signals were observed. Background: In this study, we report real-world results from the 5-year follow-up data of urothelial carcinoma patients treated with immune checkpoint blockade therapies (ICTs). Patients and Methods: Metastatic urothelial carcinoma patients treated with at least one course of ICT were included in the study. The primary endpoint was overall response rate (ORR), and secondary endpoints were overall survival (OS), progression-free survival (PFS), duration of treatment with ICT, and safety. Median follow-up, PFS, and OS were estimated by using the Kaplan-Meier method. Results: Data of 201 eligible patients were analyzed. The median age of the patients was 66 (37-86) years, and 156 (84.3%) were male. The majority of patients (94.6%) had Eastern Cooperative Oncology Group (ECOG) PS scores of 0 to 1 and primary tumor in the bladder was predominant (87.5%). The median follow-up time was 54 (1.15-65) months. The rate of complete response (CR) to ICT, partial response (PR) rate, and ORR were 10.4% (n = 21), 22.4% (n = 45), and 32.4% (n = 66), respectively. The median duration of response (DOR) was 34.8 months (95% confidence interval [CI], 29.2-42.1). Of the 66 patients who responded to treatment, 28 (42%) had an ongoing response at the time of the analysis. Median PFS and OS were 3.8 (2.6-5.8) months and 9.4 (7.4-11.4) months, respectively. The 5-year PFS and OS rates were 9.8% and 12.8%, respectively. Fifty-eight percent of patients experienced a treatment-related adverse event of any grade, and 33 (16.4%) patients had a grade 3 to 4 adverse event. Conclusion: This 5-year analysis of real-world data confirms the durable response and long-term survival with ICT in metastatic urothelial carcinoma patients.Öğe Late relapse of testicular cancer: Recurrence after 24 years and treatment with chemotherapy alone(Medknow Publications, 2015) Akar, Emre; Tural, Deniz; Arslan, Deniz; Başsorgun, Cumhur İbrahim; Yıldız, ÖzcanLate relapse of testicular cancer, defined as >2 years interval between initial treatment and recurrence, is a rare disease with the incidence rate of 2.6%. Due to its chemoresistant features, treatment options of late relapses are controversial while surgical approach and cisplatin-based chemotherapies can be considered. We report here a patient with nonseminomatous germ cell tumor who experienced relapse 24 years after his first diagnosis. After detecting left supraclavicular lymphadenopathy and absence of any other malignant lesion in positron emission tomography-computerized tomography, patient was treated with three cycles of VeIP regimen (vinblastine/ifosfamide/cisplatin). Second complete response to this treatment was achieved with chemotherapy alone.Öğe Long-term outcome and safety in patients treated with immune checkpoint blockade therapies for urothelial carcinoma: Experience from real-world clinical practice(Lippincott Williams & Wilkins, 2022) Tural, Deniz; Arslan, Çağatay; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Erman, Mustafa; Ürün, Yüksel; Karadurmuş, Nuri; Akar, Emre; Kılıçkap, SaadettinBackground: Anti-tumor activity and manageable safety profile of immune checkpoint blockade therapies (ICT) have been demonstrated in previous clinical trials in patients with metastatic urothelial carcinoma. To the best of our knowledge, very limited real-life data is available with the long follow-up time that confirms the durable antitumor activity and safety of ICT. In this study, we reported the real-life results of 56 months follow-up data of urothelial carcinoma patients who were treated with ICT. Methods: Metastatic urothelial carcinoma patients treated with at least one course of ICT included in the study. The primary endpoint was the overall response rate (ORR); secondary endpoints were overall survival (OS), progression-free survival (PFS), duration of the ICT treatment, and safety. Median follow-up, PFS, and OS were estimated by using the Kaplan-Meier method. Results: Data of 185 eligible patients were analyzed, 11.9% of these patients received the ICT as the first line, 76.8 % as the second line, and 11.3 % as the third or more line of treatment. The median age of the patients was 66 years, and 156 (84.3%) were male (37-86). The majority of patients (93.5%) had ECOG PS scores of 0–1 and primary tumor in the bladder was predominant (86.7%). The median follow-up time was 47(1.15-56) months. The complete response rate to ICT, partial response rate, and ORR were 10.3% (n = 19), 19.5% (n = 36), and 29.8% (n = 55), respectively. The median duration of response was 33.1 months (95% CI, 16.5–49.7). Of the fifty-five patients who responded to treatment, 28 (51%) had an ongoing response at the time of the analysis. Median PFS and OS was 3.8 (2.6–5.1) months and 8.9 (6.8–11.1) months, respectively. 56-month PFS and OS rate was 9.2% and 11.4%, respectively. 56-month PFS and OS rate for CR and PR was 56.2% and 20%, respectively. Fifty-nine percent of patients experienced a treatment-related adverse event of any grade, and 32 (17.3%) of patients had a grade 3–4 treatment-related adverse event. Because of treatment-related side effects, treatment was discontinued in 8 (4.3%) patients and adverse event that required systemic steroid use was reported in only 13 (7%) patients. Four patients (2.2%) died due to treatment-related causes. Conclusions: This 56-month analysis of real-world data confirms the durable response and long-term survival with ICT in metastatic urothelial carcinoma patients. The safety profile was consistent with prior reports, and no new safety signals emerged.Öğe PET-CT changes the management and improves outcome in patients with recurrent colorectal cancer(Medknow Publications, 2014) Tural, Deniz; Selçukbiricik, Fatih; Sağer, Sait; Akar, Emre; Yıldız, Özcan; Serdengeçti, SüheylaBackground: The present study aims to analyze the impact of positron emission tomography/computed tomography (PET/CT) on management change in patients with suspected or proven colorectal cancer recurrence, and to assess the effect of this management change on progression-free survival (PFS) and overall survival (OS). Materials and Methods: We retrospectively evaluated 122 patients with suspected potentially resectable recurrent colorectal cancer who underwent PET/CT scan. We determined management plans for these patients before and after the PET/CT examination. Results: While previous conventional imaging studies had revealed solitary metastases, additional sites of disease were determined by PET/CT scan in 52/122 (42%) patients. PET/CT examination results changed the treatment plan to curative intent in 35 (37%) patients. While the median PFS was 22 months (95% CI, 11.2-32.6 months) among the patients planned to receive curative treatment after the PET/CT scan, it was 11 months (95% CI, 8.1-13.9 months) in patients planned to receive curative treatment before the PET/CT examination, and the difference between median PFS durations was statistically significant (HR, 0.51 [95% CI, 0.32 - 0.88], P = 0.004). Furthermore, OS was significantly longer in patients planned to receive curative treatment after the PET/CT scan (27 months [95% CI, 22.1-31.9]) compared with those who received curative treatment before the PET/CT scan (21 months [95% CI, 15.6 - 26.4]), and the difference was statistically significant (HR, 0.63 [95% CI, 0.42 - 0.89], P = 0.045). Conclusion: The present study demonstrates the significant impact of PET/CT on the management and outcome in patients with recurrent colorectal cancer.
