Original Study|Articles in Press

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)

Published:March 18, 2023DOI:



      . 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.


      . 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<0.001). The OCB of patients with BMI >25 kg/m2 vs those with BMI ≤25 kg/m2 was significantly higher only in patients with non-clear cell histology (81% vs 65%, p=0.011), and patients with liver metastases (76% vs 58%, p=0.007), Neutrophil to Lymphocyte Ratio >4 (77% vs 62%, p=0.022) or treated by nivolumab plus ipilimumab (77% vs 64%, p=0.044). In the BMI ≤25 kg/m2 subgroup, significant differences were found between patients with NLR >4 vs ≤4 (62% vs 82%, p=0.002) and patients treated by IO+IO vs IO+TKIs combinations (64% vs 83%, p=0.002).


      : Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups.

      Clinical Practice Points

      : 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.


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