Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).

Immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) have markedly improved the prognosis of many patients with advanced non-small cell lung cancer (NSCLC). However, the relationship between the patient's nutritional/immunologic...

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Autores principales:	Shinkichi Takamori, Taro Ohba, Mototsugu Shimokawa, Taichi Matsubara, Naoki Haratake, Naoko Miura, Ryo Toyozawa, Masafumi Yamaguchi, Takashi Seto, Mitsuhiro Takenoyama
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/803957274d15404cb222923b71cf325e
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spelling	oai:doaj.org-article:803957274d15404cb222923b71cf325e2021-12-02T20:16:36ZProspective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).1932-620310.1371/journal.pone.0258616https://doaj.org/article/803957274d15404cb222923b71cf325e2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0258616https://doaj.org/toc/1932-6203Immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) have markedly improved the prognosis of many patients with advanced non-small cell lung cancer (NSCLC). However, the relationship between the patient's nutritional/immunologic status and the outcomes of ICI treatment remains unclear. In previous retrospective studies, we reported that the controlling nutritional status (CONUT) score, skeletal muscle area, and neutrophil-to-lymphocyte ratio were independent predictors of the response of NSCLC patients to anti-PD-1 drugs. The aim of this prospective multi-center study is to investigate the clinical impact of pre-treatment nutritional/immunologic indices and early post-treatment changes in the indices on treatment outcomes in advanced NSCLC. The main inclusion criteria are: (1) stage IV NSCLC, or stage III NSCLC not applicable for definitive chemoradiotherapy; (2) treatment with ICIs (monotherapy or combined with chemotherapy) as first-line therapy; and (3) available data on PD-L1 expression on tumor cells. A total of 300 patients will be enrolled prospectively. Enrollment will begin in 2020 and the final analyses will be completed by 2025.Shinkichi TakamoriTaro OhbaMototsugu ShimokawaTaichi MatsubaraNaoki HaratakeNaoko MiuraRyo ToyozawaMasafumi YamaguchiTakashi SetoMitsuhiro TakenoyamaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0258616 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Shinkichi Takamori Taro Ohba Mototsugu Shimokawa Taichi Matsubara Naoki Haratake Naoko Miura Ryo Toyozawa Masafumi Yamaguchi Takashi Seto Mitsuhiro Takenoyama Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
description	Immune checkpoint inhibitors (ICIs) targeting programmed cell death-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) have markedly improved the prognosis of many patients with advanced non-small cell lung cancer (NSCLC). However, the relationship between the patient's nutritional/immunologic status and the outcomes of ICI treatment remains unclear. In previous retrospective studies, we reported that the controlling nutritional status (CONUT) score, skeletal muscle area, and neutrophil-to-lymphocyte ratio were independent predictors of the response of NSCLC patients to anti-PD-1 drugs. The aim of this prospective multi-center study is to investigate the clinical impact of pre-treatment nutritional/immunologic indices and early post-treatment changes in the indices on treatment outcomes in advanced NSCLC. The main inclusion criteria are: (1) stage IV NSCLC, or stage III NSCLC not applicable for definitive chemoradiotherapy; (2) treatment with ICIs (monotherapy or combined with chemotherapy) as first-line therapy; and (3) available data on PD-L1 expression on tumor cells. A total of 300 patients will be enrolled prospectively. Enrollment will begin in 2020 and the final analyses will be completed by 2025.
format	article
author	Shinkichi Takamori Taro Ohba Mototsugu Shimokawa Taichi Matsubara Naoki Haratake Naoko Miura Ryo Toyozawa Masafumi Yamaguchi Takashi Seto Mitsuhiro Takenoyama
author_facet	Shinkichi Takamori Taro Ohba Mototsugu Shimokawa Taichi Matsubara Naoki Haratake Naoko Miura Ryo Toyozawa Masafumi Yamaguchi Takashi Seto Mitsuhiro Takenoyama
author_sort	Shinkichi Takamori
title	Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
title_short	Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
title_full	Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
title_fullStr	Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
title_full_unstemmed	Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).
title_sort	prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-pd-1 drugs in non-small cell lung cancer (ici-predict study).
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/803957274d15404cb222923b71cf325e
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Prospective observational study of nutritional/immunologic indices as predictive biomarkers for the response to anti-PD-1 drugs in non-small cell lung cancer (ICI-PREDICT study).

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