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

Humans Antibodies, Monoclonal, Humanized / therapeutic use Male Female Aged Middle Aged Aged, 80 and over Antineoplastic Agents, Immunological / therapeutic use Urologic Neoplasms / pathology Radiosurgery / methods Retrospective Studies Urinary Bladder Neoplasms / therapy Adult Carcinoma, Transitional Cell / therapy Treatment Outcome Combined Modality Therapy Progression-Free Survival
ARON-2 study Pembrolizumab Radiation therapy Real-world data Stereotactic radiation therapy Urothelial carcinoma

Journal

Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288

Informations de publication

Date de publication:
27 08 2024
Historique:
received: 18 02 2024
accepted: 13 08 2024
medline: 27 8 2024
pubmed: 27 8 2024
entrez: 26 8 2024
Statut: epublish

Résumé

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.

Identifiants

DOI: 10.1038/s41598-024-70182-3 PMID: 39187558
pubmed: 39187558
doi: 10.1038/s41598-024-70182-3
pii: 10.1038/s41598-024-70182-3
doi:

Substances chimiques

pembrolizumab DPT0O3T46P
Antibodies, Monoclonal, Humanized 0
Antineoplastic Agents, Immunological 0

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

19802

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Mimma Rizzo (M)

Medical Oncology Unit, Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy. rizzo.mimma@gmail.com.

Andrey Soares (A)

Medical Oncology Unit, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.

Enrique Grande (E)

Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.

Aristotelis Bamias (A)

Second Propaedeutic Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Ray Manneh Kopp (RM)

Clinical Oncology, Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia.

Edoardo Lenci (E)

Medical Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.

Thomas Buttner (T)

Department of Urology, University Hospital Bonn (UKB), Bonn, Germany.

Samer Salah (S)

Department of Medical Oncology, King Hussein Cancer Center, Amman, Jordan.

Francesco Grillone (F)

Medical Oncology Unit, Presidio Ospedaliero Pugliese Ciaccio, Azienda Ospedaliera Universitaria "Renato Dulbecco", Catanzaro, Italy.

Icaro Thiago de Carvalho (IT)

Radiation Oncology Unit, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.

Jose Carlos Tapia (JC)

Department of Medical Oncology, Institut d'Investigació Biomèdica Sant Pau, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.

Calogero Gucciardino (C)

Medical Oncology Unit, Ospedale A. Murri, Fermo, Italy.

Alvaro Pinto (A)

Medical Oncology Department, University Hospital La Paz, Madrid, Spain.

Alessia Mennitto (A)

Department of Medical Oncology, Azienda Ospedaliera Universitaria "Maggiore Della Carità", Novara, Italy.

Halima Abahssain (H)

Medicine and Pharmacy Faculty, Medical Oncology Unit, National Institute of Oncology, Mohamed V University, Rabat, Morocco.

Pasquale Rescigno (P)

Centre for Cancer, Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.

Zin Myint (Z)

Division of Medical Oncology, Markey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA.

Hideki Takeshita (H)

Department of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.

Gian Paolo Spinelli (GP)

Territorial Oncology Operative Complex Unit - Casa Della Salute di Aprilia - ASL Latina, Latina, Italy.

Lazar Popovic (L)

Oncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia.

Maria Giuseppa Vitale (MG)

Division of Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.

Ondrej Fiala (O)

Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen, Charles University, Pilsen, Czech Republic.
Biomedical Center, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic.

Patrizia Giannatempo (P)

Genitourinary Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Roubini Zakopoulou (R)

Second Propaedeutic Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Francesco Carrozza (F)

Oncology Unit, Santa Maria Delle Croci Hospital, Department Oncology and Haematology AUSL, Romagna, Ravenna, Italy.

Francesco Massari (F)

Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.

Fernando Sabino Marques Monteiro (FSM)

Oncology and Hematology Department, Hospital Sírio Libanês, Brasília, Federal District, Brazil.

Maria Paola Pace (MP)

Radiation Oncology Unit, Macerata Hospital, Macerata, Italy.

Massimo Giannini (M)

Radiation Oncology Unit, Macerata Hospital, Macerata, Italy.

Giandomenico Roviello (G)

Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Florence, Italy.

Camillo Porta (C)

Medical Oncology Unit, Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy.
Interdisciplinary Department of Medicine, University of Bari "Aldo Moro", Bari, Italy.

Nicola Battelli (N)

Medical Oncology Unit, Macerata Hospital, Macerata, Italy.

Ravindran Kanesvaran (R)

Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.

Matteo Santoni (M)

Medical Oncology Unit, Macerata Hospital, Macerata, Italy.

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