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Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies
BACKGROUND: Two phase II studies in Japan examined the efficacy and safety of nivolumab, a programmed cell death 1 receptor inhibitor, in patients with advanced squamous and non-squamous non-small cell lung cancer (ONO-4538-05 and ONO-4538-06). We examined the long-term efficacy and safety of nivolu...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767981/ https://www.ncbi.nlm.nih.gov/pubmed/33020837 http://dx.doi.org/10.1093/jjco/hyaa157 |
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author | Saka, Hideo Nishio, Makoto Hida, Toyoaki Nakagawa, Kazuhiko Sakai, Hiroshi Nogami, Naoyuki Atagi, Shinji Takahashi, Toshiaki Horinouchi, Hidehito Takenoyama, Mitsuhiro Katakami, Nobuyuki Tanaka, Hiroshi Takeda, Koji Satouchi, Miyako Isobe, Hiroshi Maemondo, Makoto Goto, Koichi Hirashima, Tomonori Minato, Koichi Yada, Nobumichi Tamura, Tomohide |
author_facet | Saka, Hideo Nishio, Makoto Hida, Toyoaki Nakagawa, Kazuhiko Sakai, Hiroshi Nogami, Naoyuki Atagi, Shinji Takahashi, Toshiaki Horinouchi, Hidehito Takenoyama, Mitsuhiro Katakami, Nobuyuki Tanaka, Hiroshi Takeda, Koji Satouchi, Miyako Isobe, Hiroshi Maemondo, Makoto Goto, Koichi Hirashima, Tomonori Minato, Koichi Yada, Nobumichi Tamura, Tomohide |
author_sort | Saka, Hideo |
collection | PubMed |
description | BACKGROUND: Two phase II studies in Japan examined the efficacy and safety of nivolumab, a programmed cell death 1 receptor inhibitor, in patients with advanced squamous and non-squamous non-small cell lung cancer (ONO-4538-05 and ONO-4538-06). We examined the long-term efficacy and safety of nivolumab in these patients treated for up to 5 years. METHODS: Patients with squamous (N = 35) or non-squamous (N = 76) non-small cell lung cancer received nivolumab (3 mg/kg every 2 weeks) until disease progression/death. Overall survival and progression-free survival were assessed at 5 years after starting treatment in separate and pooled analyses. Safety was evaluated in terms of treatment-related adverse events. RESULTS: A total of 17 patients were alive at the database lock (26 July 2019). The median overall survival (95% confidence interval) and 5-year survival rate were 16.3 (12.4–25.2) months and 14.3% in squamous patients, 17.1 (13.3–23.0) months and 19.4% in non-squamous patients and 17.1 (14.2–20.6) months and 17.8% in the pooled analysis, respectively. Programmed death ligand-1 expression tended to be greater among 5-year survivors than in non-survivors (P = 0.0703). Overall survival prolonged with increasing programmed death ligand-1 expression, with 5-year survival rates of 11.8, 21.8 and 41.7% in patients with programmed death ligand-1 expression of <1, ≥1–<50 and ≥50%, respectively. Treatment-related adverse events in ≥10% of patients (pooled analysis) included rash (15.3%), malaise (14.4%), decreased appetite (14.4%), pyrexia (14.4%) and nausea (10.8%). CONCLUSIONS: Long-term survival with nivolumab was observed in patients with squamous or non-squamous non-small cell lung cancer. No new safety signals were reported after ≥5 years of follow-up. |
format | Online Article Text |
id | pubmed-7767981 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-77679812020-12-31 Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies Saka, Hideo Nishio, Makoto Hida, Toyoaki Nakagawa, Kazuhiko Sakai, Hiroshi Nogami, Naoyuki Atagi, Shinji Takahashi, Toshiaki Horinouchi, Hidehito Takenoyama, Mitsuhiro Katakami, Nobuyuki Tanaka, Hiroshi Takeda, Koji Satouchi, Miyako Isobe, Hiroshi Maemondo, Makoto Goto, Koichi Hirashima, Tomonori Minato, Koichi Yada, Nobumichi Tamura, Tomohide Jpn J Clin Oncol Original Article BACKGROUND: Two phase II studies in Japan examined the efficacy and safety of nivolumab, a programmed cell death 1 receptor inhibitor, in patients with advanced squamous and non-squamous non-small cell lung cancer (ONO-4538-05 and ONO-4538-06). We examined the long-term efficacy and safety of nivolumab in these patients treated for up to 5 years. METHODS: Patients with squamous (N = 35) or non-squamous (N = 76) non-small cell lung cancer received nivolumab (3 mg/kg every 2 weeks) until disease progression/death. Overall survival and progression-free survival were assessed at 5 years after starting treatment in separate and pooled analyses. Safety was evaluated in terms of treatment-related adverse events. RESULTS: A total of 17 patients were alive at the database lock (26 July 2019). The median overall survival (95% confidence interval) and 5-year survival rate were 16.3 (12.4–25.2) months and 14.3% in squamous patients, 17.1 (13.3–23.0) months and 19.4% in non-squamous patients and 17.1 (14.2–20.6) months and 17.8% in the pooled analysis, respectively. Programmed death ligand-1 expression tended to be greater among 5-year survivors than in non-survivors (P = 0.0703). Overall survival prolonged with increasing programmed death ligand-1 expression, with 5-year survival rates of 11.8, 21.8 and 41.7% in patients with programmed death ligand-1 expression of <1, ≥1–<50 and ≥50%, respectively. Treatment-related adverse events in ≥10% of patients (pooled analysis) included rash (15.3%), malaise (14.4%), decreased appetite (14.4%), pyrexia (14.4%) and nausea (10.8%). CONCLUSIONS: Long-term survival with nivolumab was observed in patients with squamous or non-squamous non-small cell lung cancer. No new safety signals were reported after ≥5 years of follow-up. Oxford University Press 2020-10-06 /pmc/articles/PMC7767981/ /pubmed/33020837 http://dx.doi.org/10.1093/jjco/hyaa157 Text en © The Author(s) 2020. Published by Oxford University Press. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Saka, Hideo Nishio, Makoto Hida, Toyoaki Nakagawa, Kazuhiko Sakai, Hiroshi Nogami, Naoyuki Atagi, Shinji Takahashi, Toshiaki Horinouchi, Hidehito Takenoyama, Mitsuhiro Katakami, Nobuyuki Tanaka, Hiroshi Takeda, Koji Satouchi, Miyako Isobe, Hiroshi Maemondo, Makoto Goto, Koichi Hirashima, Tomonori Minato, Koichi Yada, Nobumichi Tamura, Tomohide Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title | Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title_full | Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title_fullStr | Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title_full_unstemmed | Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title_short | Five-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ONO-4538-05 and ONO-4538-06 studies |
title_sort | five-year follow-up results from phase ii studies of nivolumab in japanese patients with previously treated advanced non-small cell lung cancer: pooled analysis of the ono-4538-05 and ono-4538-06 studies |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767981/ https://www.ncbi.nlm.nih.gov/pubmed/33020837 http://dx.doi.org/10.1093/jjco/hyaa157 |
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