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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)

by Ohba, Taro , Takamori, Shinkichi , Shimokawa, Mototsugu , Haratake, Naoki , Seto, Takashi , Yamaguchi, Masafumi , Toyozawa, Ryo , Miura, Naoko , Takenoyama, Mitsuhiro , Matsubara, Taichi

in Analysis / Apoptosis / Biological markers / Biomarkers / Cancer therapies / Cell death / Chemoradiotherapy / Chemotherapy / Diagnosis / Drugs / Genetic aspects / GLP-1 receptor agonists / Hospitals / Immune checkpoint inhibitors / Immunosuppressive agents / Immunotherapy / Leukocytes (neutrophilic) / Lung cancer / Lung cancer, Non-small cell / Lung diseases / Lymphocytes / Medical prognosis / Muscles / Musculoskeletal system / Neutrophils / Non-small cell lung carcinoma / Nutritional status / Observational studies / Oncology / Patients / PD-1 protein / PD-L1 protein / Radiation therapy / Registered Report Protocol / Skeletal muscle / Small cell lung carcinoma / Tumor cells

2021

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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)

by Ohba, Taro , Takamori, Shinkichi , Shimokawa, Mototsugu , Haratake, Naoki , Seto, Takashi , Yamaguchi, Masafumi , Toyozawa, Ryo , Miura, Naoko , Takenoyama, Mitsuhiro , Matsubara, Taichi

2021

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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)

by Ohba, Taro , Takamori, Shinkichi , Shimokawa, Mototsugu , Haratake, Naoki , Seto, Takashi , Yamaguchi, Masafumi , Toyozawa, Ryo , Miura, Naoko , Takenoyama, Mitsuhiro , Matsubara, Taichi

2021

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Journal Article

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)

Ohba, Taro,

Takamori, Shinkichi,

Shimokawa, Mototsugu,

Haratake, Naoki,

Seto, Takashi,

Yamaguchi, Masafumi,

Toyozawa, Ryo,

Miura, Naoko,

Takenoyama, Mitsuhiro,

Matsubara, Taichi

2021

Overview

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.

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Public Library of Science,Public Library of Science (PLoS)

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