Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma.
To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma.
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.
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.
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.
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.
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.
European urology focus. 2020 Sep 30 [Epub ahead of print]
Deniz Tural, Ömer Fatih Ölmez, Ahmet Taner Sümbül, Mehmet Artaç, Nail Özhan, Emre Akar, Burcu Çakar, Osman Köstek, Meltem Ekenel, Mustafa Erman, Hasan Şenol Coşkun, Fatih Selçukbiricik, Özge Keskin, Fatma Paksoy Türköz, Kerem Oruç, Selami Bayram, Uğur Yılmaz, İrem Bilgetekin, Birol Yıldız, Mehmet Ali Nahit Şendur, Nail Paksoy, Ahmet Dirican, Dilek Erdem, Meltem Selam, Özgür Tanrıverdi, Semra Paydaş, Zuhat Urakçı, Elif Atağ, Sabri Güncan, Yüksel Ürün, Ali Alkan, Ali Osman Kaya, Deniz Tataroğlu Özyükseler, Halil Taşkaynatan, Mustafa Yıldırım, Müge Sönmez, Tuğba Başoğlu, Şeyda Gündüz, Saadettin Kılıçkap
Bakirköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey. Electronic address: ., Medipol University Hospital, Istanbul, Turkey., Medical Faculty, Baskent University, Adana, Turkey., Medical Faculty, Necmettin Erbakan University Meram, Konya, Turkey., Medical Faculty, Pamukkale University, Denizli, Turkey., Bakirköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey., Medical Faculty, Ege University, Izmir, Turkey., Medical Faculty, Trakya University, Edirne, Turkey., Istanbul University Institute of Oncology, Istanbul, Turkey., Medical Faculty, Hacettepe University, Ankara, Turkey., Medical Faculty, Akdeniz University, Antalya, Turkey., Medical Faculty, Koc University, Istanbul, Turkey., Medical Faculty, Selcuk University, Konya, Turkey., MedicalPark Goztepe Hospital, Istanbul, Turkey., Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey., Antalya Training and Research Hospital, Antalya, Turkey., MedicalPark Izmir Hospital, Izmir, Turkey., Dr. Abdurrahman Yurtaslan Ankara OncologyTraining and Research Hospital, Ankara, Turkey., Gulhane Training and Research Hospital, Ankara, Turkey., Ankara Yıldırım Beyazıt University, Faculty of Medicine, Ankara, Turkey., Medical Faculty, Celal Bayar University, Manisa, Turkey., MedicalPark Samsun Hospital, Samsun, Turkey., Liv Hospital, Istanbul, Turkey., Medical Faculty, Sitki Kocman University, Mugla, Turkey., Medical Faculty, Cukurova University, Adana, Turkey., Medical Faculty, Dicle University, Diyarbakir, Turkey., Medical Faculty, Dokuz Eylul University, Izmir, Turkey., Medical Faculty, Mersin University, Mersin, Turkey., Medical Faculty, Ankara University, Ankara, Turkey., Osmaniye State Hospital, Osmaniye, Turkey., Medicana Hospital, Istanbul, Turkey., Istanbul Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey., Katip Celebi University Atatürk Training and Research Hospital, Izmir, Turkey., MedicalPark Gaziantep Hospital, Gaziantep, Turkey., Ordu State Hospital, Ordu, Turkey., Medical Faculty, Marmara University, Istanbul, Turkey., Antalya Memorial Hospital, Antalya, Turkey., Hacettepe University Institute of Oncology, Ankara, Turkey.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/33008789