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

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

doi:10.1007/s11523-023-00978-2

Cited by 16 publications

(5 citation statements)

References 27 publications

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“…In the case of disease progression despite first-line therapy with TKIs and second-line systemic treatments, third-line targeted therapy might offer benefits; however, less than 10% of patients typically receive treatment in this scenario (Ishihara et al 2018 ; Santoni et al 2023 ). The limited utilization of third-line therapy can be attributed to the insufficient data available regarding its effectiveness and the absence of established guidelines to support its application.…”

Section: Resultsmentioning

confidence: 99%

Advanced renal cell carcinoma management: the Latin American Cooperative Oncology Group (LACOG) and the Latin American Renal Cancer Group (LARCG) consensus update

Soares,

Monteiro,

da Trindade

et al. 2024

J Cancer Res Clin Oncol

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Purpose Renal cell carcinoma is an aggressive disease with a high mortality rate. Management has drastically changed with the new era of immunotherapy, and novel strategies are being developed; however, identifying systemic treatments is still challenging. This paper presents an update of the expert panel consensus from the Latin American Cooperative Oncology Group and the Latin American Renal Cancer Group on advanced renal cell carcinoma management in Brazil. Methods A panel of 34 oncologists and experts in renal cell carcinoma discussed and voted on the best options for managing advanced disease in Brazil, including systemic treatment of early and metastatic renal cell carcinoma as well as nonclear cell tumours. The results were compared with the literature and graded according to the level of evidence. Results Adjuvant treatments benefit patients with a high risk of recurrence after surgery, and the agents used are pembrolizumab and sunitinib, with a preference for pembrolizumab. Neoadjuvant treatment is exceptional, even in initially unresectable cases. First-line treatment is mainly based on tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs); the choice of treatment is based on the International Metastatic Database Consortium (IMCD) risk score. Patients at favourable risk receive ICIs in combination with TKIs. Patients classified as intermediate or poor risk receive ICIs, without preference for ICI + ICIs or ICI + TKIs. Data on nonclear cell renal cancer treatment are limited. Active surveillance has a place in treating favourable-risk patients. Either denosumab or zoledronic acid can be used for treating metastatic bone disease. Conclusion Immunotherapy and targeted therapy are the standards of care for advanced disease. The utilization and sequencing of these therapeutic agents hinge upon individual risk scores and responses to previous treatments. This consensus reflects a commitment to informed decision-making, drawn from professional expertise and evidence in the medical literature.

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Section: Resultsmentioning

confidence: 99%

Advanced renal cell carcinoma management: the Latin American Cooperative Oncology Group (LACOG) and the Latin American Renal Cancer Group (LARCG) consensus update

Soares,

Monteiro,

da Trindade

et al. 2024

J Cancer Res Clin Oncol

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“…The first-line combinations have shown an advantage in terms of overall survival (OS) (range HR: 0.70–0.84), progression-free survival (PFS) (range HR: 0.47–0.86) and overall response rate (ORR) (range: 39.3–71.3% vs 28–40%) 1 , 3 compared with sunitinib.…”

Section: Introductionmentioning

confidence: 99%

“…With different immuno-combinations (ICI-ICI or ICI-TKI) available and lack of predictive factors that may guide the clinical decisions, the choice of the first-line strategy remains challenging. 3 The two types of immuno-combinations differentiate, other than the toxicity profile, for the derived clinical outcomes in terms of ORR and PFS that generally favor the ICI-TKI combination. 1 , 4 , 5 However, the survival updates reported at ASCO 2023 have raised many questions on the long-term survival benefit of the main first-line immuno-combinations approved in Europe.…”

Section: Introductionmentioning

confidence: 99%

Banana-shaped survival curves of metastatic renal cell carcinoma treated with first-line immune-combinations, not just a matter of “palateau”

Rebuzzi,

Fornarini,

Signori

et al. 2024

Human Vaccines & Immunotherapeutics

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The first-line therapy of metastatic renal cell carcinoma (mRCC) has revolutionized with the approval of immune checkpoint inhibitors (ICIs) in combination with or without tyrosine kinase inhibitors (TKIs). The choice among the many different immuno-combinations (ICI-ICI or ICI-TKI) is challenging due to the lack of predictive factors. The different shapes of the Kaplan–Meier survival curves (e.g. “banana-shaped curves”) have raised many questions on the long-term survival benefit. Here, we analyzed the factors that could have impacted the different long-term survival, including the prognostic factors distribution (IMDC score), histological factors (sarcomatoid features, PD-L1 expression), and treatment characteristics (mechanism of action, duration, discontinuation rate). This overview highlights the factors that should be considered in the first-line setting for the patients’ therapeutic choice and prognostic assessment. They are also fundamental parameters to examined for head-to-head studies and real-life, large-scale studies.

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“…With such a wide range of different treatment combinations now available, comparative analyses of their effectiveness and safety would be needed for guiding optimal rst-line therapy selection. On this scenario, the ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immune combinations as rst-line therapy for mRCC [12][13][14][15]. In this sub-analysis, we conducted a retrospective comparison of the effectiveness of PA versus NC as rst-line therapy in patients with advanced RCC.…”

Section: Introductionmentioning

confidence: 99%

Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

Santoni,

Roviello,

Grande

et al. 2024

Preprint

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Background The optimal first-line therapy for metastatic renal cell carcinoma (mRCC) remains uncertain, despite recent advancements in immune-based combinations. This retrospective study compares the effectiveness of pembrolizumab plus axitinib (PA) and nivolumab plus cabozantinib (NC) as first-line treatments for mRCC in a real-world setting. Methods Patient data were collected from 55 centres across 16 countries, encompassing individuals diagnosed with mRCC receiving first-line treatment with PA or NC between January 2016 and October 2023. Clinical and tumour features and treatment responses were recorded. The primary endpoints were overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to second progression. Statistical analyses included Kaplan-Meier survival estimates, Cox proportional hazard models, and chi-square tests. Results A total of 760 patients with a median age of 64 years (range, 29–88) were included. Of them, 607 received PA, and only 153 NC. Median OS was 55.7 months and not reached (NR) for PA and NC, respectively (P = .51), while median PFS was longer with NC (27.6 months) than for PA (16.2 months, P = .003). Subgroup analysis suggested a PFS benefits for NC in male, younger patients, intermediate-risk group, clear cell histology, and lung involvement, as well as ORR favoured NC in good risk patients. Multivariate analysis identified first-line therapy as a significant factor associated with PFS. Conclusions In this certainly biased retrospective comparison, NC demonstrated superior ORR and longer PFS compared to PA in mRCC. These findings underscore the importance of considering individual patient characteristics and risk profiles when selecting first-line therapy for mRCC.

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

Cited by 16 publications

References 27 publications

Advanced renal cell carcinoma management: the Latin American Cooperative Oncology Group (LACOG) and the Latin American Renal Cancer Group (LARCG) consensus update

Advanced renal cell carcinoma management: the Latin American Cooperative Oncology Group (LACOG) and the Latin American Renal Cancer Group (LARCG) consensus update

Banana-shaped survival curves of metastatic renal cell carcinoma treated with first-line immune-combinations, not just a matter of “palateau”

Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)

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