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Multicenter Study
. 2025 Jan;57(1):23-29.
doi: 10.1016/j.dld.2024.05.005. Epub 2024 May 21.

The Prognostic Nutritional Index in patients with microsatellite instability-high metastatic gastric or gastroesophageal cancers receiving immune checkpoint inhibitors

Filippo Ghelardi  1 , Giovanni Fucà  1 , Chiara Cavalli  1 , Kohei Shitara  2 , Romain Cohen  3 , Margherita Ambrosini  1 , Steven B Maron  4 , Riccardo Cerantola  5 , Vincenzo Nasca  1 , Giorgia Di Liberti  1 , Luca Zambelli  1 , Michele Palazzo  1 , Massimiliano Salati  6 , Yu Aoki  2 , Akihito Kawazoe  2 , Darren Cowzer  4 , Sara Lonardi  7 , Thierry André  3 , Giovanni Randon  1 , Filippo Pietrantonio  8
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Free article
Multicenter Study

The Prognostic Nutritional Index in patients with microsatellite instability-high metastatic gastric or gastroesophageal cancers receiving immune checkpoint inhibitors

Filippo Ghelardi et al. Dig Liver Dis. 2025 Jan.
Free article

Abstract

Background: Microsatellite instability high (MSI-H) and/or mismatch repair deficient (dMMR) status is the strongest predictive factor for immune checkpoint inhibitors (ICIs) benefit in patients with metastatic gastroesophageal cancer (mGC). Primary resistance to ICIs is a relevant issue, but prognostic and predictive factors are lacking.

Materials and methods: In this multinational, retrospective cohort of patients with MSI-H/dMMR mGC treated with ICIs without chemotherapy we collected baseline laboratory values to establish the prognostic nutritional index (PNI). We evaluated the association between baseline PNI with the activity and efficacy of ICIs.

Results: At a median follow-up of 31.6 months, median progression-free survival (PFS) and 2-year PFS rate were not reached and 73.6 % in the PNI-high subgroup versus 6.3 months and 38.3 % in the PNI-low one (HR 0.32, 95 % CI: 0.16-0.61, p < .001). Median overall survival (OS) and 2-year OS rate were not reached and 81.9 % in the PNI-high subgroup versus 24.4 months and 50.5 % in the PNI-low one (HR 0.26, 95 % CI: 0.12-0.56, p < .001). In multivariable models, high PNI was associated with longer PFS and OS (HR 0.30, 95 % CI: 0.15-0.61, p <0.001 and 0.37, 95 % CI: 0.15-0.91, p = .031).

Conclusions: High PNI is associated with longer PFS and OS, in patients with MSI-H mGC receiving ICIs. Patients with low baseline PNI may benefit from intensive therapeutic approaches.

Keywords: Gastric cancer; Immune checkpoint inhibitors; Msi-h; Nutritional status; Prognostic factors.

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Conflict of interest statement

Conflict of interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RC has received personal fees from Astra-Zeneca, Bristol-Myers Squibb, Exeliom Biosciences, Enterome Bioscience, MSD Oncology, Mylan Medical, Pierre Fabre, Servier and non-financial support from Amgen, Bristol-Myers Squibb, Mylan Medical and Servier outside the submitted work. SBM received consulting fees from Natera, Bicara, Novartis, Basilea, Elevation Oncology, and Daiichi Sankyo. AK reports receiving honoraria (lecture fee) from Lilly, Bristol Myers Squibb, Ono Pharmaceutical, Merck Pharmaceutical, Taiho Pharmaceutical, Daiichi Sankyo; receiving personal fees for advisory roles from Merck Pharmaceutical, Zymeworks; and receiving research funding from AstraZeneca, outside the submitted work. SL reports roles as consultant or advisor for Amgen, Astra Zeneca, Bristol-Myers Squibb, Daiichi-Sankyo, Incyte, Lilly, Merck Serono, MSD, Servier, and reports research funding from Amgen, Astellas, Astra-Zeneca, Bayer, BMS Daichii Sankyo, Hutchinson, Incyte, Merck Serono, Mirati, MSD, Pfizer, Roche. She is part of speakers’ bureau of Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Merck Serono, Pierre Fabre, Roche, Servier. KS reports receiving personal fees for advisory roles from Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical, Merck Pharmaceutical, Taiho Pharmaceutical, Astellas, Novartis, AbbVie, GlaxoSmithKline, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan, and Janssen; receiving honoraria (lecture fee) from Takeda, Bristol-Myers Squibb and Janssen; and receiving research funding from Astellas, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Chugai, Merck Pharmaceutical, Medi Science, Eisai and Amgen, outside the submitted work. TA reports attending advisory board meetings and receiving consulting fees from Aptitude heath, AstraZeneca, Astellas, Bristol Myers Squibb, Gritstone Oncology, GamaMabs Pharma Sa, Gilead, GlaxoSmithKline, Merck & Co. Inc., Nordic Oncology, Pierre Fabre, Seagen, Servier and Transgène; honoraria from AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Merck & Co. Inc., Pierre Fabre, Roche, Sanofi Seagen and Servier; and support for meetings from Merck & Co. Inc. and Servier. FP reported receiving grants from BMS, Incyte, and AstraZeneca, Amgen and Agenus, and personal fees from BMS, MSD, Amgen, Merck-Serono, Pierre-Fabre, Servier, Bayer, Takeda, Astellas, Ipsen, GSK outside the submitted work. No other competing interests to disclose.

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