Ralph Burger1, Jonas Jarczyk1, Niklas Westhoff1, Thomas S Worst1, Jonas Herrmann1, Kirsten Merx2, Anja Weidner3, Petra Unglaub4, Markus Müller4, Philipp Nuhn1, Maurice Stephan Michel1, Jost von Hardenberg5. 1. Klinik für Urologie und Urochirurgie, Universitätsklinikum Mannheim, Medizinische Fakultät Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Deutschland. 2. III. Medizinische Klinik, Universitätsklinikum Mannheim, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Deutschland. 3. Klinik für Radiologie und Nuklearmedizin, Universitätsklinikum Mannheim, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Deutschland. 4. Klinik für Urologie, Klinikum Ludwigshafen, Ludwigshafen, Deutschland. 5. Klinik für Urologie und Urochirurgie, Universitätsklinikum Mannheim, Medizinische Fakultät Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Deutschland. jost.vonhardenberg@medma.uni-heidelberg.de.
Abstract
BACKGROUND: Immune checkpoint inhibitors (ICI) have been approved in uro-oncology for a few years. Real-world experience regarding benefits and risks with novel side effects are rare. MATERIALS AND METHODS: In a retrospective analysis, all patients who received ICI therapy due to metastatic renal cell carcinoma (NCC) or urothelial carcinoma (UCA) were enrolled at two maximum care hospitals in Germany between July 2016 and May 2021. Radiologic response, progression-free survival (PFS), and adverse events leading to treatment interruption were collected. Oncologic response was compared to randomized controlled trials. RESULTS: In all, 1185 ICI cycles were administered to 145 patients (111 men [77%] and 34 women [23%]): 64 (44.1 %) patients with NCC and 81 (55.9%) patients with UCA received ICI therapy. Of 141 patients with radiological follow-up, an objective response was observed in 21.3% (n = 13) of patients with NCC and 20.0% (n = 16) with UCA (median duration of response 14.9 months [3.0-51.3]). Median PFS was 5.3 months in patients with NCC and 4.8 months with UCA. ICI-associated adverse events requiring treatment interruption were observed in 17.2% patients with NCC and 20.9% with UCA. These were most commonly renal (5.5%: nephritis) and gastrointestinal (4.8%: colitis, diarrhea) adverse events. Hospitalization was required for 22 (15.1%) patients. CONCLUSION: This real-world experience may support patient-centered consultation in treatment decision-making. Further studies on prognostic factors are needed. Therapy interruptions are frequent and the spectrum of side effects requires interdisciplinary treatment.
BACKGROUND: Immune checkpoint inhibitors (ICI) have been approved in uro-oncology for a few years. Real-world experience regarding benefits and risks with novel side effects are rare. MATERIALS AND METHODS: In a retrospective analysis, all patients who received ICI therapy due to metastatic renal cell carcinoma (NCC) or urothelial carcinoma (UCA) were enrolled at two maximum care hospitals in Germany between July 2016 and May 2021. Radiologic response, progression-free survival (PFS), and adverse events leading to treatment interruption were collected. Oncologic response was compared to randomized controlled trials. RESULTS: In all, 1185 ICI cycles were administered to 145 patients (111 men [77%] and 34 women [23%]): 64 (44.1 %) patients with NCC and 81 (55.9%) patients with UCA received ICI therapy. Of 141 patients with radiological follow-up, an objective response was observed in 21.3% (n = 13) of patients with NCC and 20.0% (n = 16) with UCA (median duration of response 14.9 months [3.0-51.3]). Median PFS was 5.3 months in patients with NCC and 4.8 months with UCA. ICI-associated adverse events requiring treatment interruption were observed in 17.2% patients with NCC and 20.9% with UCA. These were most commonly renal (5.5%: nephritis) and gastrointestinal (4.8%: colitis, diarrhea) adverse events. Hospitalization was required for 22 (15.1%) patients. CONCLUSION: This real-world experience may support patient-centered consultation in treatment decision-making. Further studies on prognostic factors are needed. Therapy interruptions are frequent and the spectrum of side effects requires interdisciplinary treatment.