Abstract
Immune checkpoint inhibitors (ICI) have been approved in uro-oncology for afew years. Real-world experience regarding benefits and risks with novel side effects are rare. In aretrospective 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. In all, 1185 ICI cycles were administered to 145 patients (111 men [77%] and 34women [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 5.3months in patients with NCC and 4.8months 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. 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.
Highlights
Radiologic response, progression-free survival (PFS), and adverse events leading to treatment interruption were collected
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 urothelial carcinoma (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
Summary
In der retrospektiven Analyse wurden alle Patienten erfasst, die bei metastasiertem NCC oder UCA im Zeitraum zwischen Juli 2016 und Mai 2021 an der Klinik für Urologie und Urochirurgie der Universitätsmedizin Mannheim und am Krankenhaus der Maximalversorgung Klinikum Lud-. 3 und 4 zeigt sich darüber hinaus, dass die Mehrzahl der Patienten unter ICI im NCC und UCA zumindest eine stabile Erkrankung hatten, auch wenn eine ORR bildmorphologisch nicht nachweisbar war. In einer ebenfalls retrospektiven Analyse von Patienten mit ICI-Therapie bei NCC von Ma et al zeigte sich eine PFS von 5,0 Monaten vergleichbar zu den vorliegenden Daten [25]. In einer retrospektiven Serie von Patienten mit UCA unter ICI zeigte sich bei Patienten mit PS ≥ 2 in der Erstlinie ein deutlich kürzeres Überleben als bei Patienten mit PS 0 oder 1 (7,2 vs 15,2 Monate; [27]). Sonpavde et al identifizierten in einer Kohorte von Patienten mit fortgeschrittenem oder metastasierten UCA unter ICI die folgenden Faktoren mit dem Risiko für ein kurzes Gesamtüberleben: schlechter PS, Lebermetastasen, niedrige Thrombozyten, hohes. Weitere Details zur Lizenz entnehmen Sie bitte der Lizenzinformation auf http://creativecommons.org/ licenses/by/4.0/deed.de
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