%0 Journal Article
%T Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study.
%A Santoni M
%A Myint ZW
%A Büttner T
%A Takeshita H
%A Okada Y
%A Lam ET
%A Gilbert D
%A Küronya Z
%A Tural D
%A Pichler R
%A Grande E
%A Crabb SJ
%A Kemp R
%A Massari F
%A Scagliarini S
%A Iacovelli R
%A Vau N
%A Basso U
%A Maruzzo M
%A Molina-Cerrillo J
%A Galli L
%A Bamias A
%A De Giorgi U
%A Zucali PA
%A Rizzo M
%A Seront E
%A Popovic L
%A Caffo O
%A Buti S
%A Kanesvaran R
%A Kopecky J
%A Kucharz J
%A Zeppellini A
%A Fiala O
%A Landmesser J
%A Ansari J
%A Giannatempo P
%A Rizzo A
%A Zabalza IO
%A Monteiro FSM
%A Battelli N
%A Calabrò F
%A Porta C
%J Cancer Immunol Immunother
%V 72
%N 9
%D 2023 Sep 29
%M 37248424
%F 6.63
%R 10.1007/s00262-023-03469-5
%X <B>BACKGROUND: </B>The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.<BR><B>METHODS: </B>Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.<BR><B>RESULTS: </B>Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.<BR><B>CONCLUSIONS: </B>Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.