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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| Abstract |
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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| Authors | Shinkichi Takamori, Taro Ohba, Mototsugu Shimokawa, Taichi Matsubara, Naoki Haratake, Naoko Miura, Ryo Toyozawa, Masafumi Yamaguchi, Takashi Seto, Mitsuhiro Takenoyama |
| Journal | PloS one (PLoS One) Vol. 16 Issue 10 Pg. e0258616 ( 2021) ISSN: 1932-6203 [Electronic] United States |
| PMID | 34679113 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't) |
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