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1. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1).

Author

Santoni, Matteao, Massari, Francesco, Myint, Zin W., Iacovelli, Roberto, Pichler, Martin, Basso, Umberto, Kopecky, Jindrich, Kucharz, Jakub, Buti, Sebastiano, Salfi, Alessia, Büttner, Thomas, De Giorgi, Ugo, Kanesvaran, Ravindran, Fiala, Ondřej, Grande, Enrique, Zucali, Paolo Andrea, Fornarini, Giuseppe, Bourlon, Maria T., Scagliarini, Sarah, and Molina-Cerrillo, Javier

Subjects
*BODY mass index, *RENAL cell carcinoma, *RENAL cancer treatment, *CANCER immunotherapy, *UNIVARIATE analysis
Abstract

Obesity is a well-known risk factor for the development of renal cell carcinoma (RCC), one of the most frequent malignant urogenital tumors. The development of immunotherapy (IO)-based combinations for the treatment of metastatic RCC (mRCC) has led to a marked improvement of patients' outcomes and quality of life. The ARON-1 study (NCT05287464) was designed to globally analyze real-world treatment outcomes of mRCC patients receiving first-line immune-based combinations. In this sub-analysis, we investigated the role of body mass index (BMI) in patients treated by immuno-oncology combinations stratified by clinico-pathological features. According to our results, the prognostic significance and the association of BMI with treatment outcome may vary across clinico-pathological mRCC subgroups. Background: Obesity has been associated with improved response to immunotherapy in cancer patients. We investigated the role of body mass index (BMI) in patients from the ARON-1 study (NCT05287464) treated by dual immunooncology agents (IO + IO) or a combination of immuno-oncology drug and a tyrosine kinase inhibitors (TKI) as firstline therapy for metastatic renal cell carcinoma (mRCC). Patients and Methods: Medical records of patients with documented mRCC treated by immuno-oncology combinations were reviewed at 47 institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (OS), and overall clinical benefit (OCB), defined as the sum of the rate of partial/complete responses and stable disease. Univariate and multivariate analyses were used to explore the association of variables of interest with survival. Results: A total of 675 patients were included; BMI was > 25 kg/m 2 in 345 patients (51%) and was associated with improved OS (55.7 vs. 28.4 months, P < .001). The OCB of patients with BMI > 25 kg/m 2 versus those with BMI =25 kg/m 2 was significantly higher only in patients with nonclear cell histology (81% vs. 65%, P = .011), and patients with liver metastases (76% vs. 58%, P = .007), Neutrophil to lymphocyte ratio > 4 (77% vs 62%, P = .022) or treated by nivolumab plus ipilimumab (77% vs. 64%, P = .044). In the BMI =25 kg/m 2 subgroup, significant differences were found between patients with NLR > 4 versus =4 (62% vs. 82%, P = .002) and patients treated by IO + IO versus IO + TKIs combinations (64% vs. 83%, P = .002). Conclusion: Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups. [ABSTRACT FROM AUTHOR]

Published
2023
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2. Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1)

Author

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

Subjects
Tumor Response, Oncology, Survival, Urology, Immunocombo, NCT05287464, Immunotherapy, Obesity, mRCC
Abstract

Background: Obesity has been associated with improved response to immunotherapy in cancer patients. We investigated the role of body mass index (BMI) in patients from the ARON-1 study (NCT05287464) treated by dual immuno-oncology agents (IO+IO) or a combination of immuno-oncology drug and a tyrosine kinase inhibitors (TKI) as first-line therapy for metastatic renal cell carcinoma (mRCC). Patients and methods: Medical records of patients with documented mRCC treated by immuno-oncology combinations were reviewed at 47 institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (OS), and overall clinical benefit (OCB), defined as the sum of the rate of partial/complete responses and stable disease. Univariate and multivariate analyses were used to explore the association of variables of interest with survival. Results: A total of 675 patients were included; BMI was >25 kg/m2 in 345 patients (51%) and was associated with improved OS (55.7 vs. 28.4 months, P < .001). The OCB of patients with BMI >25 kg/m2 versus those with BMI ≤25 kg/m2 was significantly higher only in patients with nonclear cell histology (81% vs. 65%, P = .011), and patients with liver metastases (76% vs. 58%, P = .007), Neutrophil to lymphocyte ratio >4 (77% vs 62%, P = .022) or treated by nivolumab plus ipilimumab (77% vs. 64%, P=.044). In the BMI ≤25 kg/m2 subgroup, significant differences were found between patients with NLR >4 versus ≤4 (62% vs. 82%, P = .002) and patients treated by IO+IO versus IO+TKIs combinations (64% vs. 83%, P = .002). Conclusion: Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups.

Published
2023

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