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Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study

We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into interme...

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Autores principales: Iinuma, Koji, Kameyama, Koji, Kawada, Kei, Fujimoto, Shota, Takagi, Kimiaki, Nagai, Shingo, Ito, Hiroki, Ishida, Takashi, Kawase, Makoto, Kawase, Kota, Nakai, Chie, Kato, Daiki, Takai, Manabu, Nakane, Keita, Koie, Takuya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167798/
https://www.ncbi.nlm.nih.gov/pubmed/33916792
http://dx.doi.org/10.3390/curroncol28020133
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author Iinuma, Koji
Kameyama, Koji
Kawada, Kei
Fujimoto, Shota
Takagi, Kimiaki
Nagai, Shingo
Ito, Hiroki
Ishida, Takashi
Kawase, Makoto
Kawase, Kota
Nakai, Chie
Kato, Daiki
Takai, Manabu
Nakane, Keita
Koie, Takuya
author_facet Iinuma, Koji
Kameyama, Koji
Kawada, Kei
Fujimoto, Shota
Takagi, Kimiaki
Nagai, Shingo
Ito, Hiroki
Ishida, Takashi
Kawase, Makoto
Kawase, Kota
Nakai, Chie
Kato, Daiki
Takai, Manabu
Nakane, Keita
Koie, Takuya
author_sort Iinuma, Koji
collection PubMed
description We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively (p = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively (p = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI.
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spelling pubmed-81677982021-06-02 Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study Iinuma, Koji Kameyama, Koji Kawada, Kei Fujimoto, Shota Takagi, Kimiaki Nagai, Shingo Ito, Hiroki Ishida, Takashi Kawase, Makoto Kawase, Kota Nakai, Chie Kato, Daiki Takai, Manabu Nakane, Keita Koie, Takuya Curr Oncol Article We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively (p = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively (p = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI. MDPI 2021-04-03 /pmc/articles/PMC8167798/ /pubmed/33916792 http://dx.doi.org/10.3390/curroncol28020133 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Iinuma, Koji
Kameyama, Koji
Kawada, Kei
Fujimoto, Shota
Takagi, Kimiaki
Nagai, Shingo
Ito, Hiroki
Ishida, Takashi
Kawase, Makoto
Kawase, Kota
Nakai, Chie
Kato, Daiki
Takai, Manabu
Nakane, Keita
Koie, Takuya
Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title_full Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title_fullStr Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title_full_unstemmed Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title_short Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study
title_sort efficacy and safety of nivolumab and ipilimumab for advanced or metastatic renal cell carcinoma: a multicenter retrospective cohort study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167798/
https://www.ncbi.nlm.nih.gov/pubmed/33916792
http://dx.doi.org/10.3390/curroncol28020133
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