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

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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.

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Acknowledgements

None to declare.

Author information

Author notes

  1. Matteo Santoni and Francesco Massari have equally contributed.

  2. Nicola Battelli and Camillo Porta are co-senior authors.

Authors and Affiliations

  1. Oncology Unit, Macerata Hospital, Via Santa Lucia 2, 62100, Macerata, Italy

    Matteo Santoni, Giulia Sorgentoni & Nicola Battelli

  2. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni-15, Bologna, Italy

    Francesco Massari & Veronica Mollica

  3. Markey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA

    Zin W. Myint

  4. Oncologia Medica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

    Roberto Iacovelli

  5. Division of Oncology, Department of Internal Medicine, Medical University of Graz, Augenbruggerplatz 15, 8010, Graz, Austria

    Martin Pichler

  6. Oncology 3 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy

    Umberto Basso

  7. Department of Clinical Oncology and Radiotherapy, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic

    Jindrich Kopecky

  8. Department of Uro-oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

    Jakub Kucharz

  9. Medical Oncology Unit, Department of Medicine and Surgery, University Hospital of Parma, University of Parma, Parma, Italy

    Sebastiano Buti

  10. Division of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124, Bari, Italy

    Mimma Rizzo & Camillo Porta

  11. Oncology Unit 2, University Hospital of Pisa, 56126, Pisa, Italy

    Luca Galli

  12. Department of Urology, University Hospital Bonn (UKB), 53127, Bonn, Germany

    Thomas Büttner

  13. Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy

    Ugo De Giorgi

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

    Ravindran Kanesvaran

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

    Ondřej Fiala

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

    Enrique Grande & Ignacio Ortego Zabalza

  17. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

    Paolo Andrea Zucali

  18. Department of Oncology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Paolo Andrea Zucali

  19. IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    Giuseppe Fornarini

  20. Hematology and Oncology Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico

    Maria T. Bourlon

  21. UOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy

    Sarah Scagliarini

  22. Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain

    Javier Molina-Cerrillo

  23. Medical Oncology Division of Urogenital and Head and Neck Tumours, IEO, European Institute of Oncology IRCCS, Milan, Italy

    Gaetano Aurilio

  24. Department of Internal Medicine, Hematology/Oncology, Ochsner Medical Center, New Orleans, LA, USA

    Marc R. Matrana

  25. Department of Urology, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria

    Renate Pichler

  26. Department of Medical Oncology, “Maggiore della Carità” University Hospital, 28100, Novara, Italy

    Carlo Cattrini

  27. Department of Oncology, First Faculty of Medicine, Charles University, Thomayer University Hospital, 14059, Prague, Czech Republic

    Tomas Büchler

  28. Department of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint Paul, Belgium

    Emmanuel Seront

  29. Department of Oncology, San Camillo Forlanini Hospital, Rome, Italy

    Fabio Calabrò

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

    Alvaro Pinto

  31. Department of Medical Oncology, Università Politecnica delle Marche, AOU Ospedali Riuniti delle Marche, Ancona, Italy

    Rossana Berardi

  32. Department of Oncology-Radiotherapy, Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania

    Anca Zgura

  33. Department of Radiological, Oncological and Anatomo-Pathological Science, “Sapienza” University of Rome, Viale Regina Elena 324, 00185, Rome, Italy

    Giulia Mammone

  34. Medical Oncology, Tawam Hospital, Al Ain, United Arab Emirates

    Jawaher Ansari

  35. Unità di Oncologia Medica, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy

    Francesco Atzori

  36. UOC Oncologia, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Tuscany, Italy

    Rita Chiari

  37. 2nd Propaedeutic Department of Internal Medicine, School of Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, Athens, Greece

    Aristotelis Bamias

  38. Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy

    Orazio Caffo

  39. Dipartimento di Oncologia Medica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

    Giuseppe Procopio

  40. Oncologia Medica, Ospedale Maggiore di Cremona, Cremona, Italy

    Giuseppe Procopio

  41. Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome, Italy

    Maria Bassanelli

  42. Section of Oncology, Department of Medicine, University of Verona School of Medicine, Verona University Hospital Trust, Verona, Italy

    Sara Merler

  43. Oncology Unit, A.R.N.A.S. Civico, Palermo, Italy

    Carlo Messina

  44. Department of Genitourinary Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary

    Zsófia Küronya

  45. Oncology, Candiolo Cancer Institute, IRCCS-FPO, 10060, Turin, Italy

    Alessandra Mosca

  46. Department of Medical Oncology, Army Hospital Research and Referral, New Delhi, India

    Dipen Bhuva

  47. Urologic Oncology, Champalimaud Clinical Center, 1400-038, Lisbon, Portugal

    Nuno Vau

  48. Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy

    Lorena Incorvaia

  49. Medical Oncology, Ospedale San Paolo, 17100, Savona, Italy

    Sara Elena Rebuzzi

  50. Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genoa, Genoa, Italy

    Sara Elena Rebuzzi

  51. Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy

    Giandomenico Roviello

  52. Struttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico Globale del Paziente Oncologico “Don Tonino Bello”, I.R.C.C.S. Istituto Tumori “Giovanni Paolo II”, Viale Orazio Flacco 65, 70124, Bari, Italy

    Alessandro Rizzo

  53. Latin American Cooperative Oncology Group-LACOG, Porto Alegre, Brazil

    Fernando Sabino M. Monteiro

  54. Oncology and Hematology Department, Hospital Santa Lucia, SHLS 716 Cj. C, Brasília, DF, 70390-700, Brazil

    Fernando Sabino M. Monteiro

  55. Molecular Medicine and Cell Therapy Foundation, Polytechnic University of the Marche Region, 60126, Ancona, Italy

    Rodolfo Montironi

  56. Chair of Oncology, Interdisciplinary Department of Medicine, University of Bari “Aldo Moro”, Bari, Italy

    Camillo Porta

Authors
  1. Matteo Santoni
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  2. Francesco Massari
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  3. Zin W. Myint
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  4. Roberto Iacovelli
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  5. Martin Pichler
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  6. Umberto Basso
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  7. Jindrich Kopecky
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  8. Jakub Kucharz
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  9. Sebastiano Buti
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  10. Mimma Rizzo
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  11. Luca Galli
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  12. Thomas Büttner
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  13. Ugo De Giorgi
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  14. Ravindran Kanesvaran
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  15. Ondřej Fiala
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  16. Enrique Grande
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  17. Paolo Andrea Zucali
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  18. Giuseppe Fornarini
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  19. Maria T. Bourlon
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  20. Sarah Scagliarini
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  21. Javier Molina-Cerrillo
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  22. Gaetano Aurilio
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  24. Renate Pichler
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  25. Carlo Cattrini
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  26. Tomas Büchler
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  27. Emmanuel Seront
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  28. Fabio Calabrò
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  29. Alvaro Pinto
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  30. Rossana Berardi
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  31. Anca Zgura
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  32. Giulia Mammone
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  33. Jawaher Ansari
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  34. Francesco Atzori
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  35. Rita Chiari
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  36. Aristotelis Bamias
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  38. Giuseppe Procopio
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  39. Maria Bassanelli
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  40. Sara Merler
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  43. Alessandra Mosca
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  48. Giandomenico Roviello
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  49. Ignacio Ortego Zabalza
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  51. Veronica Mollica
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  52. Giulia Sorgentoni
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  53. Fernando Sabino M. Monteiro
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  55. Nicola Battelli
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  56. Camillo Porta
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Corresponding author

Correspondence to Matteo Santoni.

Ethics declarations

Conflict of interest

Matteo Santoni has received research support and honoraria from Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas, and Bayer, all unrelated to the present paper. R. Kanesvaran has received fees for speaker bureau and advisory board activities from the following companies: Pfizer, MSD, BMS, Eisai, Ipsen, Johnson and Johnson, Merck, Amgen, Astellas, and Bayer. Enrique Grande has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Adacap, AMGEN, Angelini, Astellas, Astra Zeneca, Bayer, Blueprint, Bristol Myers Squibb, Caris Life Sciences, Celgene, Clovis-Oncology, Eisai, Eusa Pharma, Genetracer, Guardant Health, HRA-Pharma, IPSEN, ITM-Radiopharma, Janssen, Lexicon, Lilly, Merck KGaA, MSD, Nanostring Technologies, Natera, Novartis, ONCODNA (Biosequence), Palex, Pharmamar, Pierre Fabre, Pfizer, Roche, Sanofi-Genzyme, Servier, Taiho, and Thermo Fisher Scientific. EG has received research grants from Pfizer, Astra Zeneca, Astellas, and Lexicon Pharmaceuticals. Tomas Buchler has received research support and honoraria from Roche, Bristol Myers Squibb, Ipsen, Exelixis, Eisai, Merck Sharp Dohme, Merck, Eli Lilly, and AstraZeneca, all unrelated to the present paper. Aristotelis Bamias has received honoraria/advisory/research support by Pfizer, BMS, AZ, MSD, Roche, Janssen, Ipsen, Bayer, and Merck. Fernando Sabino Marques Monteiro has received research support from Janssen and Merck Sharp Dome and honoraria from Janssen, Ipsen, Bristol Myers Squibb, and Merck Sharp Dome. Camillo Porta has received honoraria from Angelini Pharma, AstraZeneca, BMS, Eisai, General Electric, Ipsen, and MSD and acted as a Protocol Steering Committee Member for BMS, Eisai, and MSD. The other authors declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

Funding

No external funding was used in the preparation of this manuscript.

Ethics approval, Consent to Participate

This retrospective research was carried out in accordance with the approval from the ethics committee of the Marche Region (2021-492) and was performed in accordance with the Declaration of Helsinki.

Availability of data

All data generated or analyzed during this study are included in this published article (and its supplementary information files). The datasets generated during and/or analyzed during the current study are not publicly available in accordance with all the centers participating to the ARON project but are available from the corresponding author on reasonable request.

Author contributions

Conceptualization: Matteo Santoni, Camillo Porta, Gaetano Aurilio. Data curation: Matteo Santoni, Francesco Massari, Fernando Sabino M. Monteiro, Zin W. Myint, Umberto Basso, Jindrich Kopecky, Jakub Kucharz, Mimma Rizzo1 Luca Galli, Thomas Büttner, Ugo De Giorgi, Ondřej Fiala, Paolo Andrea Zucali, Giuseppe Fornarini, Maria T Bourlon, Sarah Scagliarini, Javier Molina-Cerrillo, Marc R Matrana, Renate Pichler, Carlo Cattrini, Emmanuel Seront, Alvaro Pinto, Rossana Berardi, Anca Zgura, Giulia Mammone, Jawaher Ansari, Francesco Atzori, Rita Chiari, 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. Formal analysis: Matteo Santoni. Investigation: Francesco Massari. Methodology: Alessandro Rizzo, Ignacio Ortego Zabalza, Roberto Iacovelli, Martin Pichler. Project administration: Giulia Sorgentoni. Supervision: Enrique Grande, Aristotelis Bamias, Fabio Calabrò. Roles/writing—original draft: Matteo Santoni, Veronica Mollica, Sebastiano Buti. Writing—review & editing: Tomas Büchler, Ravindran Kanesvaran, Camillo Porta, Nicola Battelli, Rodolfo Montironi.

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Santoni, M., Massari, F., Myint, Z.W. et al. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Targ Oncol 18, 559–570 (2023). https://doi.org/10.1007/s11523-023-00978-2

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