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Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting
We aimed to identify the clinical characteristics related to increased nivolumab exposure in Japanese patients with renal cell carcinoma (RCC) in real-world clinical setting. Eleven patients were treated with the originally approved nivolumab dosing regimen of 3 mg/kg every 2 weeks (Q2W) (3-mg/kg gr...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Neoplasia Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205763/ https://www.ncbi.nlm.nih.gov/pubmed/32375081 http://dx.doi.org/10.1016/j.tranon.2020.100771 |
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author | Kato, Renpei Ikarashi, Daiki Matsuura, Tomohiko Maekawa, Shigekatsu Kato, Yoichiro Kanehira, Mitsugu Takata, Ryo Tokuyama, Rie Tamai, Kanako Harigai, Naoto Nakazaki, Yukoh Obara, Wataru |
author_facet | Kato, Renpei Ikarashi, Daiki Matsuura, Tomohiko Maekawa, Shigekatsu Kato, Yoichiro Kanehira, Mitsugu Takata, Ryo Tokuyama, Rie Tamai, Kanako Harigai, Naoto Nakazaki, Yukoh Obara, Wataru |
author_sort | Kato, Renpei |
collection | PubMed |
description | We aimed to identify the clinical characteristics related to increased nivolumab exposure in Japanese patients with renal cell carcinoma (RCC) in real-world clinical setting. Eleven patients were treated with the originally approved nivolumab dosing regimen of 3 mg/kg every 2 weeks (Q2W) (3-mg/kg group) and 8 patients with a flat dose of 240 mg Q2W (flat dosing group). Trough concentrations (C(min)) until the fifth cycle were measured by sandwich enzyme-linked immunosorbent assay using anti-nivolumab monoclonal antibody established by the Autonomously Diversifying Library system. Mean C(min) at four cycles of nivolumab were significantly higher in the flat dosing group than in the 3-mg/kg group. In an analysis of covariates related to nivolumab concentration, serum albumin (Alb) was significantly lower in the 3-mg/kg group than in the flat dose group. C(min) correlated significantly with serum Alb at all cycles. In conclusion, serum Alb was a potential clinically relevant covariate for nivolumab pharmacokinetics in Japanese RCC patients. Further studies should verify whether serum Alb affects nivolumab efficacy and toxicity. |
format | Online Article Text |
id | pubmed-7205763 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Neoplasia Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-72057632020-05-11 Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting Kato, Renpei Ikarashi, Daiki Matsuura, Tomohiko Maekawa, Shigekatsu Kato, Yoichiro Kanehira, Mitsugu Takata, Ryo Tokuyama, Rie Tamai, Kanako Harigai, Naoto Nakazaki, Yukoh Obara, Wataru Transl Oncol Original article We aimed to identify the clinical characteristics related to increased nivolumab exposure in Japanese patients with renal cell carcinoma (RCC) in real-world clinical setting. Eleven patients were treated with the originally approved nivolumab dosing regimen of 3 mg/kg every 2 weeks (Q2W) (3-mg/kg group) and 8 patients with a flat dose of 240 mg Q2W (flat dosing group). Trough concentrations (C(min)) until the fifth cycle were measured by sandwich enzyme-linked immunosorbent assay using anti-nivolumab monoclonal antibody established by the Autonomously Diversifying Library system. Mean C(min) at four cycles of nivolumab were significantly higher in the flat dosing group than in the 3-mg/kg group. In an analysis of covariates related to nivolumab concentration, serum albumin (Alb) was significantly lower in the 3-mg/kg group than in the flat dose group. C(min) correlated significantly with serum Alb at all cycles. In conclusion, serum Alb was a potential clinically relevant covariate for nivolumab pharmacokinetics in Japanese RCC patients. Further studies should verify whether serum Alb affects nivolumab efficacy and toxicity. Neoplasia Press 2020-05-03 /pmc/articles/PMC7205763/ /pubmed/32375081 http://dx.doi.org/10.1016/j.tranon.2020.100771 Text en © 2020 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original article Kato, Renpei Ikarashi, Daiki Matsuura, Tomohiko Maekawa, Shigekatsu Kato, Yoichiro Kanehira, Mitsugu Takata, Ryo Tokuyama, Rie Tamai, Kanako Harigai, Naoto Nakazaki, Yukoh Obara, Wataru Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title | Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title_full | Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title_fullStr | Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title_full_unstemmed | Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title_short | Analyses of Nivolumab Exposure and Clinical Safety Between 3-mg/kg Dosing and 240-mg Flat Dosing in Asian Patients with Advanced Renal Cell Carcinoma in the Real-World Clinical Setting |
title_sort | analyses of nivolumab exposure and clinical safety between 3-mg/kg dosing and 240-mg flat dosing in asian patients with advanced renal cell carcinoma in the real-world clinical setting |
topic | Original article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205763/ https://www.ncbi.nlm.nih.gov/pubmed/32375081 http://dx.doi.org/10.1016/j.tranon.2020.100771 |
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