Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey
Deniz Tural , Omer Fatih Olmez , Ahmet Taner Sumbul , Mehmet Artac , Nail Ozhan , Emre Akar , Burcu Cakar , Osman Kostek , Nail Paksoy , Mustafa Erman , Hasan Senol Coskun , Fatih Selcukbiricik , Özge Keskin , Fatma Paksoy Turkoz , Kerem Oruc , Selami Bayram , Ugur Yilmaz , Irem Bilgetekin , Birol Yildiz , Saadettin Kilickap
Background: Anti-tumor activity and manageable safety profile of atezolizumab (ATZ) has been demonstrated in the previous clinical trials in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma. In this study, we reported the results of real-life data of urothelial carcinoma patients in Turkey who were treated with ATZ. Methods: Data of the patients with metastatic urothelial carcinoma registered to ATZ Expanded-Access Program and treated with at least one course of ATZ from 36 oncology centers in Turkey were collected. The primary endpoint was the overall response rate (ORR); secondary endpoints were overall survival (OS), progression-free survival (PFS), duration of the ATZ treatment and safety. Results: Data of 115 eligible patients were analyzed. Of the patients, 100 (87%) were male and 13% were female. The median age was 65.3 years (37-86). Most of the patients (92.3%) had received only one chemotherapy regimen prior to ATZ. The median follow-up time was 23.5 months. The complete response rate to ATZ, 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 months (95% CI 6.47–28.8). Of the thirty-three patients who responded to treatment, 20 (60%) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 months (95% 2.25–5.49) and 9.8 months (95% 6.7–12.9), respectively. The 12-month PFS rate was 22.3% and the 24-month PFS rate was 16.9%. The 12-month OS rate was 42.2% and the 24-month OS rate was 23.5%, respectively. Sixty-four percent of patients experienced a treatment-related adverse event of any grade, and 24 (20%) of patients had a grade 3–4 treatment-related adverse event. Because of treatment-related side effects, dose reduction was performed in 9 (7.8%) patients and ATZ was discontinued in 8 patients (7.0%). Adverse event that required systemic steroid use was reported in only 7 (6.1%) patients. Four patients (3.5%) died due to treatment-related causes. Conclusions: ATZ is an effective and tolerable treatment for patients with metastatic platinum-resistant urothelial carcinoma.
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Abstract Disclosures
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