Geographical differences in the management of metastatic de novo renal cell carcinoma in the era of immune-combinations

Porta, Camillo; Bamias, Aristotelis; Zakopoulou, Roubini; Myint, Zin; Cavasin, Nicolò; Iacovelli, Roberto; Pichler, Martin; Kopecký, J; Kucharz, Jakub; Rizzo, Mimma; Galli, Luca; Büttner, Thomas; Giorgi, Ugo De; Kanesvaran, Ravindran; Fiala, Ondřej; Grande, Enrique; Zucali, Paolo Andrea; Kopp, Ray Manneh; FORNARINI, Giuseppe; Bourlon, María Teresa; Scagliarini, Sarah; Molina‐Cerrillo, Javier; Aurilio, Gaetano; Matrana, Marc; Pichler, Renate; Cattrini, Carlo; Büchler, Tomáš; Massari, Francesco; Mollica, Veronica; Seront, Emmanuel; Calabrò, Fabio; Pinto, Álvaro; Berardi, Rossana; ZGURA, Anca; Mammone, Giulia; Ansari, Jawaher; Atzori, Francesco; Chiari, Rita; Caffo, Orazio; Procopio, Giuseppe; Sunela, Kaisa; Bassanelli, Maria; Ortega, Cinzia; Grillone, Francesco; Landmesser, Johannes; Merler, Sara; Messina, Carlo; Küronya, Zsófia; Mosca, Alessandra; Bhuva, Dipen; Santini, Daniele; Vau, Nuno; Morelli, Franco; Incorvaia, Lorena; REBUZZI, Sara E.; Roviello, Giandomenico; Soares, Andrey; Zabalza, Ignacio Ortego; RIZZO, Alessandro; Bisonni, Renato; Pierantoni, Francesco; Sorgentoni, Giulia; Monteiro, Fernando Sabino Marques; Battelli, Nicola; BUTI, Sebastiano; Santoni, Matteo

doi:10.23736/s2724-6051.23.05369-7

Cited by 7 publications

(2 citation statements)

References 16 publications

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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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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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“…The ARON-1 study (ClinicalTrials.gov identifier NCT05287464) was a multicenter, international, retrospective study to collect real-world data on clinical outcomes of metastatic RCC patients treated with immuno-oncology combinations as first-line therapy [ 23 , 24 ]. In the current manuscript, we present the results from the analysis focused on the impact of sex on immune-based combinations effectiveness, stratified by ICI plus ICI, or ICI plus anti-angiogenic agent.…”

Section: Introductionmentioning

confidence: 99%

Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations

Incorvaia,

Monteiro,

Massari

et al. 2024

Cancer Immunol Immunother

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Background There is an ongoing debate as to whether sex could be associated with immune checkpoint inhibitor (ICI) benefit. Existing literature data reveal contradictory results, and data on first-line immune combinations are lacking. Method This was a real-world, multicenter, international, observational study to determine the sex effects on the clinical outcomes in metastatic renal cell carcinoma (mRCC) patients treated with immuno-oncology combinations as first-line therapy. Results A total of 1827 mRCC patients from 71 cancer centers in 21 countries were included. The median OS was 38.7 months (95% CI 32.7–44.2) in the overall study population: 40.0 months (95% CI 32.7–51.6) in males and 38.7 months (95% CI 26.4–41.0) in females (p = 0.202). The median OS was higher in males vs. females in patients aged 18-49y (36.9 months, 95% CI 29.0–51.6, vs. 24.8 months, 95% CI 16.8–40.4, p = 0.426, with + 19% of 2y-OS rate, 72% vs. 53%, p = 0.006), in the clear cell histology subgroup (44.2 months, 95% CI 35.8–55.7, vs. 38.7 months, 95% CI 26.0–41.0, p = 0.047), and in patients with sarcomatoid differentiation (34.4 months, 95% CI 26.4–59.0, vs. 15.3 months, 95% CI 8.9–41.0, p < 0.001). Sex female was an independent negative prognostic factor in the sarcomatoid population (HR 1.72, 95% CI 1.15 − 2.57, p = 0.008). Conclusions Although the female’s innate and adaptive immunity has been observed to be more active than the male’s, women in the subgroup of clear cell histology, sarcomatoid differentiation, and those under 50 years of age showed shorter OS than males.

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Real-World Primary Resistance to First-Line Immune-Based Combinations in Patients with Advanced Renal Cell Carcinoma (ARON-1)

Santini,

Li,

Roviello

et al. 2024

Targ Oncol

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Geographical differences in the management of metastatic de novo renal cell carcinoma in the era of immune-combinations

Cited by 7 publications

References 16 publications

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

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

Sex and survival outcomes in patients with renal cell carcinoma receiving first-line immune-based combinations

Real-World Primary Resistance to First-Line Immune-Based Combinations in Patients with Advanced Renal Cell Carcinoma (ARON-1)

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