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.
Scientific reports. 2024 Aug 27*** epublish ***
Mimma Rizzo, Andrey Soares, Enrique Grande, Aristotelis Bamias, Ray Manneh Kopp, Edoardo Lenci, Thomas Buttner, Samer Salah, Francesco Grillone, Icaro Thiago de Carvalho, Jose Carlos Tapia, Calogero Gucciardino, Alvaro Pinto, Alessia Mennitto, Halima Abahssain, Pasquale Rescigno, Zin Myint, Hideki Takeshita, Gian Paolo Spinelli, Lazar Popovic, Maria Giuseppa Vitale, Ondrej Fiala, Patrizia Giannatempo, Roubini Zakopoulou, Francesco Carrozza, Francesco Massari, Fernando Sabino Marques Monteiro, Maria Paola Pace, Massimo Giannini, Giandomenico Roviello, Camillo Porta, Nicola Battelli, Ravindran Kanesvaran, Matteo Santoni
Medical Oncology Unit, Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy. ., Medical Oncology Unit, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil., Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain., Second Propaedeutic Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece., Clinical Oncology, Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia., Medical Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy., Department of Urology, University Hospital Bonn (UKB), Bonn, Germany., Department of Medical Oncology, King Hussein Cancer Center, Amman, Jordan., Medical Oncology Unit, Presidio Ospedaliero Pugliese Ciaccio, Azienda Ospedaliera Universitaria "Renato Dulbecco", Catanzaro, Italy., Radiation Oncology Unit, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil., Department of Medical Oncology, Institut d'Investigació Biomèdica Sant Pau, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain., Medical Oncology Unit, Ospedale A. Murri, Fermo, Italy., Medical Oncology Department, University Hospital La Paz, Madrid, Spain., Department of Medical Oncology, Azienda Ospedaliera Universitaria "Maggiore Della Carità", Novara, Italy., Medicine and Pharmacy Faculty, Medical Oncology Unit, National Institute of Oncology, Mohamed V University, Rabat, Morocco., Centre for Cancer, Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK., Division of Medical Oncology, Markey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA., Department of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan., Territorial Oncology Operative Complex Unit - Casa Della Salute di Aprilia - ASL Latina, Latina, Italy., Oncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia., Division of Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen, Charles University, Pilsen, Czech Republic., Genitourinary Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy., Oncology Unit, Santa Maria Delle Croci Hospital, Department Oncology and Haematology AUSL, Romagna, Ravenna, Italy., Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy., Oncology and Hematology Department, Hospital Sírio Libanês, Brasília, Federal District, Brazil., Radiation Oncology Unit, Macerata Hospital, Macerata, Italy., Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Florence, Italy., Medical Oncology Unit, Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy., Medical Oncology Unit, Macerata Hospital, Macerata, Italy., Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.