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Published in: Targeted Oncology 4/2023

27-06-2023 | Kidney Cancer | Original Research Article

Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study

Authors: Matteo Santoni, Francesco Massari, Zin W. Myint, Roberto Iacovelli, Martin Pichler, Umberto Basso, Jindrich Kopecky, Jakub Kucharz, Sebastiano Buti, Mimma Rizzo, Luca Galli, Thomas Büttner, Ugo De Giorgi, Ravindran Kanesvaran, Ondřej Fiala, Enrique Grande, Paolo Andrea Zucali, Giuseppe Fornarini, Maria T. Bourlon, Sarah Scagliarini, Javier Molina-Cerrillo, Gaetano Aurilio, Marc R. Matrana, Renate Pichler, Carlo Cattrini, Tomas Büchler, Emmanuel Seront, Fabio Calabrò, Alvaro Pinto, Rossana Berardi, Anca Zgura, Giulia Mammone, Jawaher Ansari, Francesco Atzori, Rita Chiari, Aristotelis Bamias, Orazio Caffo, Giuseppe Procopio, Maria Bassanelli, Sara Merler, Carlo Messina, Zsófia Küronya, Alessandra Mosca, Dipen Bhuva, Nuno Vau, Lorena Incorvaia, Sara Elena Rebuzzi, Giandomenico Roviello, Ignacio Ortego Zabalza, Alessandro Rizzo, Veronica Mollica, Giulia Sorgentoni, Fernando Sabino M. Monteiro, Rodolfo Montironi, Nicola Battelli, Camillo Porta

Published in: Targeted Oncology | Issue 4/2023

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Abstract

Background

Immuno-oncology combinations have achieved survival benefits in patients with metastatic renal cell carcinoma (mRCC).

Objective

The ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immuno-combinations as first-line therapy for mRCC patients.

Patients and Methods

Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of mRCC treated with first-line immuno-combination therapies were retrospectively included from 47 International Institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall clinical benefit (OCB).

Results

A total of 729 patients were included; tumor histology was clear-cell RCC in 86% of cases; 313 patients received dual immuno-oncology (IO + IO) therapy while 416 were treated with IO-tyrosine kinase inhibitor (IO + TKI) combinations. In the overall study population, the median OS and PFS were 36.5 and 15.0 months, respectively. The median OS was longer with IO+TKI compared with IO+IO therapy in the 616 patients with intermediate/poor International mRCC Database Consortium (IMDC) risk criteria (55.7 vs 29.7 months; p = 0.045). OCB was 84% for IO+TKI and 72% for IO + IO combination (p < 0.001).

Conclusions

Our study may suggest that immuno-oncology combinations are effective as first-line therapy in the mRCC real-world context, showing outcome differences between IO + IO and IO + TKI combinations in mRCC subpopulations.

Clinical Trial Registration

NCT05287464.
Appendix
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Metadata
Title
Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study
Authors
Matteo Santoni
Francesco Massari
Zin W. Myint
Roberto Iacovelli
Martin Pichler
Umberto Basso
Jindrich Kopecky
Jakub Kucharz
Sebastiano Buti
Mimma Rizzo
Luca Galli
Thomas Büttner
Ugo De Giorgi
Ravindran Kanesvaran
Ondřej Fiala
Enrique Grande
Paolo Andrea Zucali
Giuseppe Fornarini
Maria T. Bourlon
Sarah Scagliarini
Javier Molina-Cerrillo
Gaetano Aurilio
Marc R. Matrana
Renate Pichler
Carlo Cattrini
Tomas Büchler
Emmanuel Seront
Fabio Calabrò
Alvaro Pinto
Rossana Berardi
Anca Zgura
Giulia Mammone
Jawaher Ansari
Francesco Atzori
Rita Chiari
Aristotelis Bamias
Orazio Caffo
Giuseppe Procopio
Maria Bassanelli
Sara Merler
Carlo Messina
Zsófia Küronya
Alessandra Mosca
Dipen Bhuva
Nuno Vau
Lorena Incorvaia
Sara Elena Rebuzzi
Giandomenico Roviello
Ignacio Ortego Zabalza
Alessandro Rizzo
Veronica Mollica
Giulia Sorgentoni
Fernando Sabino M. Monteiro
Rodolfo Montironi
Nicola Battelli
Camillo Porta
Publication date
27-06-2023
Publisher
Springer International Publishing
Published in
Targeted Oncology / Issue 4/2023
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI
https://doi.org/10.1007/s11523-023-00978-2

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