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Radiotherapy plus pembrolizumab for advanced urothelial carcinoma: results from the ARON-2 real-world study

Lookup NU author(s): Dr Pasquale RescignoORCiD

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

© The Author(s) 2024.The addition of metastasis-directed radiotherapy (MDRT) to immunotherapy in patients with advanced urothelial carcinoma (aUC) has shown promising results. We report the real-world data from the ARON-2 study (NCT05290038) on the impact of conventional (CRT) or stereotactic body radiotherapy (SBRT) on the outcome of aUC patients receiving pembrolizumab after platinum-based-chemotherapy. Medical records of 837 patients were reviewed from 60 institutions in 20 countries. Two hundred and sixty-two patients (31%) received radiotherapy (cohort A), of whom 193 (23%) received CRT and 69 (8%) received SBRT. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. With a median follow-up of 22.7 months, the median OS was 10.2 months, 6.8 months and 16.0 months in no RT, CRT and SBRT subgroups (p = 0.005), with an 1y-OS rates of 47%, 34% and 61%, respectively (p < 0.001). The 1y-OS rate in the SBRT subgroup were significantly higher for both lower (63%) and upper tract UC (68%), for pure urothelial histology (63%) and variant histologies (58%), and for patients with bone (40%) and lymph-node metastases (61%). Median PFS was 4.8 months, 9.6 months and 5.8 months in the CRT, SBRT and no RT subgroups, respectively (p = 0.060). The 1y-PFS rate was significantly higher (48%) in the SBRT population and was confirmed in all patient subsets. The difference in terms of ORR was in favour of SBRT. Our real-world analysis showed that the use of SBRT/pembrolizumab combination may play a role in a subset of aUC patients to increase disease control and possibly overall survival.


Publication metadata

Author(s): Rizzo M, Soares A, Grande E, Bamias A, Kopp RM, Lenci E, Buttner T, Salah S, Grillone F, de Carvalho IT, Tapia JC, Gucciardino C, Pinto A, Mennitto A, Abahssain H, Rescigno P, Myint Z, Takeshita H, Spinelli GP, Popovic L, Vitale MG, Fiala O, Giannatempo P, Zakopoulou R, Carrozza F, Massari F, Monteiro FSM, Pace MP, Giannini M, Roviello G, Porta C, Battelli N, Kanesvaran R, Santoni M

Publication type: Article

Publication status: Published

Journal: Scientific Reports

Year: 2024

Volume: 14

Issue: 1

Online publication date: 27/08/2024

Acceptance date: 13/08/2024

Date deposited: 07/11/2024

ISSN (electronic): 2045-2322

Publisher: Nature Research

URL: https://doi.org/10.1038/s41598-024-70182-3

DOI: 10.1038/s41598-024-70182-3

Data Access Statement: The datasets used and/or analysed during this study are available from the last author upon reasonable request.

PubMed id: 39187558


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