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Multicenter Study
. 2024 Jul 5:15:1361010.
doi: 10.3389/fimmu.2024.1361010. eCollection 2024.

Sodium levels and immunotherapy efficacy in mRCC patients with bone metastases: sub analysis of Meet-Uro 15 study

Martina Catalano  1 , Sara Elena Rebuzzi  2   3 , Marco Maruzzo  4 , Ugo De Giorgi  5 , Sebastiano Buti  6   7 , Luca Galli  8 , Giuseppe Fornarini  9 , Paolo Andrea Zucali  10   11 , Melanie Claps  12 , Silvia Chiellino  13 , Ilaria Zampiva  14 , Stefania Pipitone  15 , Riccardo Ricotta  16 , Mariella Sorarù  17 , Veronica Mollica  18 , Marianna Tudini  19 , Lucia Fratino  20 , Veronica Prati  21 , Orazio Caffo  22 , Francesco Atzori  23 , Franco Morelli  24 , Giuseppe Prati  25 , Franco Nolè  26 , Francesca Vignani  27 , Alessia Cavo  28 , Marilena Di Napoli  29 , Andrea Malgeri  30 , Emanuele Naglieri  31 , Alessio Signori  32 , Giuseppe Luigi Banna  33 , Pasquale Rescigno  34 , Linda Cerbone  35 , Lorenzo Antonuzzo #  36   37 , Giandomenico Roviello #  1
Affiliations
Multicenter Study

Sodium levels and immunotherapy efficacy in mRCC patients with bone metastases: sub analysis of Meet-Uro 15 study

Martina Catalano et al. Front Immunol. .

Abstract

Background: Immune-checkpoint inhibitors (ICIs) have significantly improved metastatic renal cell carcinoma (mRCC) prognosis, although their efficacy in patients with bone metastases (BMs) remains poorly understood. We investigated the prognostic role of natremia in pretreated RCC patients with BMs receiving immunotherapy.

Materials and methods: This retrospective multicenter study included RCC patients with BMs receiving nivolumab as second-line therapy or beyond. Inclusion criteria involved baseline sodium levels (pre-ICI) and sodium levels after 4 weeks of nivolumab initiation (post-ICI). The population was divided into two groups based on the median value, and response rates, progression-free survival (PFS), and overall survival (OS) were assessed.

Results: Among 120 eligible patients, those with pre-treatment sodium levels ≥140 mEq/L showed longer OS (18.7 vs. 12.0 months, p=0.04). Pre-treatment sodium levels ≥140 mEq/L were associated with better OS compared to levels <140 mE/L (18.7 vs. 12.0, p=0.04). Post-treatment sodium levels ≥140 mEq/L were associated with improved PFS (9.6 vs. 3.2 months) and OS (25.1 vs. 8.8 months) (p=0.05 and p<0.01, respectively). Patients with consistent sodium levels ≥140 mEq/L at both time points exhibited the best outcomes compared to those with lower values (PFS 11.5 vs. 3.3 months and OS 42.2 vs. 9.0 months, respectively, p<0.01). Disease control rate was significantly higher in the latter group (p<0.01). Multivariate analysis confirmed the prognostic significance of sodium levels.

Conclusion: Elevated sodium levels (≥140 mEq/L) pre- and post-ICI treatment correlate with better survival outcomes in mRCC patients with BMs. This finding suggests sodium level assessment as a potential prognostic factor in these patients and warrants further investigation, particularly in combination immunotherapy settings.

Keywords: bone metastases; efficacy outcomes; immunotherapy; renal cell carcinoma; sodium levels.

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Conflict of interest statement

GB: Speaker bureau: Astellas, Astrazeneca, Amgen. Patents: n. 4 patents with ST Microelectronics. Travel, Accommodations for scientific conferences: Merck, Janssen. UG: services as advisory/board member of Astellas, Bayer, BMS, IPSEN, Janssen, Merck, Pfizer, Sanofi, received research grant/funding to the institution from AstraZeneca, Roche, Sanofi and travel/accommodations/expenses from BMS BMS, IPSEN, Janssen, Pfizer. LC: has received honoraria for advisory boards, speaker engagements and scientific consultancy for educational purposes from AstraZeneca, EISAI, MSD, Ipsen, BMS, A.A.A.; past MSD employee in Medical Affairs. MS: honoraria as consultant or advisory role from Janssen; grant for participation at scientific events: Astellas Pharma, Sanofi, Roche Novartis, Ipsen, Janssen, Bristol Myers Squibb, Pfizer; research funding: Roche, Merck, Janssen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier survival estimate according to pre-ICI sodium value.
Figure 2
Figure 2
Kaplan-Meier survival estimate according to post-ICI sodium value.
Figure 3
Figure 3
Kaplan-Meier survival estimate according to both pre-and post-ICI sodium serum values.
See this image and copyright information in PMC

Comment in

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