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Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study

INTRODUCTION: Necitumumab plus gemcitabine and cisplatin (GCN) is a standard therapy for patients with advanced lung squamous cell carcinoma (LSqCC). However, the efficacy and tolerability of GCN in second-line or later treatment for patients previously treated with immune checkpoint inhibitors (ICI...

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Autores principales: Murata, Yasunori, Tanzawa, Shigeru, Misumi, Toshihiro, Yoshioka, Hiroshige, Miyauchi, Eisaku, Ninomiya, Kiichiro, Takeshita, Masafumi, Ito, Kensaku, Okamoto, Tatsuro, Sugawara, Shunichi, Kawashima, Yosuke, Hashimoto, Kazuki, Mori, Masahide, Miyanaga, Akihiko, Hayashi, Anna, Tanaka, Hisashi, Honda, Ryoichi, Nojiri, Masafumi, Sato, Yuki, Hata, Akito, Masuda, Ken, Kozuki, Toshiyuki, Kawamura, Takahisa, Suzuki, Takuji, Yamaguchi, Teppei, Asada, Kazuhiro, Tetsumoto, Satoshi, Tanaka, Hiroshi, Watanabe, Satoshi, Umeda, Yukihiro, Yamaguchi, Kakuhiro, Kuyama, Shoichi, Tsuruno, Kosuke, Misumi, Yuki, Kuraishi, Hiroshi, Yoshihara, Ken, Nakao, Akira, Kubo, Akihito, Yokoyama, Toshihiko, Watanabe, Kana, Seki, Nobuhiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10689269/
https://www.ncbi.nlm.nih.gov/pubmed/38046378
http://dx.doi.org/10.1016/j.jtocrr.2023.100593
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author Murata, Yasunori
Tanzawa, Shigeru
Misumi, Toshihiro
Yoshioka, Hiroshige
Miyauchi, Eisaku
Ninomiya, Kiichiro
Takeshita, Masafumi
Ito, Kensaku
Okamoto, Tatsuro
Sugawara, Shunichi
Kawashima, Yosuke
Hashimoto, Kazuki
Mori, Masahide
Miyanaga, Akihiko
Hayashi, Anna
Tanaka, Hisashi
Honda, Ryoichi
Nojiri, Masafumi
Sato, Yuki
Hata, Akito
Masuda, Ken
Kozuki, Toshiyuki
Kawamura, Takahisa
Suzuki, Takuji
Yamaguchi, Teppei
Asada, Kazuhiro
Tetsumoto, Satoshi
Tanaka, Hiroshi
Watanabe, Satoshi
Umeda, Yukihiro
Yamaguchi, Kakuhiro
Kuyama, Shoichi
Tsuruno, Kosuke
Misumi, Yuki
Kuraishi, Hiroshi
Yoshihara, Ken
Nakao, Akira
Kubo, Akihito
Yokoyama, Toshihiko
Watanabe, Kana
Seki, Nobuhiko
author_facet Murata, Yasunori
Tanzawa, Shigeru
Misumi, Toshihiro
Yoshioka, Hiroshige
Miyauchi, Eisaku
Ninomiya, Kiichiro
Takeshita, Masafumi
Ito, Kensaku
Okamoto, Tatsuro
Sugawara, Shunichi
Kawashima, Yosuke
Hashimoto, Kazuki
Mori, Masahide
Miyanaga, Akihiko
Hayashi, Anna
Tanaka, Hisashi
Honda, Ryoichi
Nojiri, Masafumi
Sato, Yuki
Hata, Akito
Masuda, Ken
Kozuki, Toshiyuki
Kawamura, Takahisa
Suzuki, Takuji
Yamaguchi, Teppei
Asada, Kazuhiro
Tetsumoto, Satoshi
Tanaka, Hiroshi
Watanabe, Satoshi
Umeda, Yukihiro
Yamaguchi, Kakuhiro
Kuyama, Shoichi
Tsuruno, Kosuke
Misumi, Yuki
Kuraishi, Hiroshi
Yoshihara, Ken
Nakao, Akira
Kubo, Akihito
Yokoyama, Toshihiko
Watanabe, Kana
Seki, Nobuhiko
author_sort Murata, Yasunori
collection PubMed
description INTRODUCTION: Necitumumab plus gemcitabine and cisplatin (GCN) is a standard therapy for patients with advanced lung squamous cell carcinoma (LSqCC). However, the efficacy and tolerability of GCN in second-line or later treatment for patients previously treated with immune checkpoint inhibitors (ICIs) remain unknown. METHODS: This multicenter, retrospective, cohort study assessed the efficacy and tolerability of GCN initiated between November 1, 2019 and March 31, 2022 as second-line to fourth-line treatment in patients with advanced LSqCC who had been pretreated with ICIs. The primary end point was progression-free survival (PFS). RESULTS: A total of 93 patients from 35 institutions in Japan were enrolled. The median PFS, median overall survival (OS), and objective response rate were 4.4 months (95% confidence interval [CI]: 3.8–5.3), 13.3 months (95% CI: 9.6–16.5), and 27.3% (95% CI: 18.3–37.8), respectively. The median PFS, median OS, and objective response rate for second-line, third-line, and fourth-line treatment groups were 4.8 months, 3.8 months, and 4.3 months (p = 0.24); 15.7 months, 11.6 months, and 10.1 months (p = 0.06); and 31.0%, 13.6%, and 37.5% (p = 0.22), respectively. The severity of GCN-related skin disorders was associated with longer PFS (p < 0.05) and OS (p < 0.05). The frequencies of grade ≥3 skin disorders, hypomagnesemia, pneumonitis, and febrile neutropenia were 16.1%, 7.5%, 1.1%, and 4.3%, respectively. There were no treatment-related deaths. CONCLUSIONS: GCN for ICI-pretreated patients with LSqCC seems tolerable and offers promising efficacy regardless of treatment line, and ICI pretreatment might enhance GCN efficacy.
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spelling pubmed-106892692023-12-02 Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study Murata, Yasunori Tanzawa, Shigeru Misumi, Toshihiro Yoshioka, Hiroshige Miyauchi, Eisaku Ninomiya, Kiichiro Takeshita, Masafumi Ito, Kensaku Okamoto, Tatsuro Sugawara, Shunichi Kawashima, Yosuke Hashimoto, Kazuki Mori, Masahide Miyanaga, Akihiko Hayashi, Anna Tanaka, Hisashi Honda, Ryoichi Nojiri, Masafumi Sato, Yuki Hata, Akito Masuda, Ken Kozuki, Toshiyuki Kawamura, Takahisa Suzuki, Takuji Yamaguchi, Teppei Asada, Kazuhiro Tetsumoto, Satoshi Tanaka, Hiroshi Watanabe, Satoshi Umeda, Yukihiro Yamaguchi, Kakuhiro Kuyama, Shoichi Tsuruno, Kosuke Misumi, Yuki Kuraishi, Hiroshi Yoshihara, Ken Nakao, Akira Kubo, Akihito Yokoyama, Toshihiko Watanabe, Kana Seki, Nobuhiko JTO Clin Res Rep Original Article INTRODUCTION: Necitumumab plus gemcitabine and cisplatin (GCN) is a standard therapy for patients with advanced lung squamous cell carcinoma (LSqCC). However, the efficacy and tolerability of GCN in second-line or later treatment for patients previously treated with immune checkpoint inhibitors (ICIs) remain unknown. METHODS: This multicenter, retrospective, cohort study assessed the efficacy and tolerability of GCN initiated between November 1, 2019 and March 31, 2022 as second-line to fourth-line treatment in patients with advanced LSqCC who had been pretreated with ICIs. The primary end point was progression-free survival (PFS). RESULTS: A total of 93 patients from 35 institutions in Japan were enrolled. The median PFS, median overall survival (OS), and objective response rate were 4.4 months (95% confidence interval [CI]: 3.8–5.3), 13.3 months (95% CI: 9.6–16.5), and 27.3% (95% CI: 18.3–37.8), respectively. The median PFS, median OS, and objective response rate for second-line, third-line, and fourth-line treatment groups were 4.8 months, 3.8 months, and 4.3 months (p = 0.24); 15.7 months, 11.6 months, and 10.1 months (p = 0.06); and 31.0%, 13.6%, and 37.5% (p = 0.22), respectively. The severity of GCN-related skin disorders was associated with longer PFS (p < 0.05) and OS (p < 0.05). The frequencies of grade ≥3 skin disorders, hypomagnesemia, pneumonitis, and febrile neutropenia were 16.1%, 7.5%, 1.1%, and 4.3%, respectively. There were no treatment-related deaths. CONCLUSIONS: GCN for ICI-pretreated patients with LSqCC seems tolerable and offers promising efficacy regardless of treatment line, and ICI pretreatment might enhance GCN efficacy. Elsevier 2023-10-20 /pmc/articles/PMC10689269/ /pubmed/38046378 http://dx.doi.org/10.1016/j.jtocrr.2023.100593 Text en © 2023 The Authors https://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
Murata, Yasunori
Tanzawa, Shigeru
Misumi, Toshihiro
Yoshioka, Hiroshige
Miyauchi, Eisaku
Ninomiya, Kiichiro
Takeshita, Masafumi
Ito, Kensaku
Okamoto, Tatsuro
Sugawara, Shunichi
Kawashima, Yosuke
Hashimoto, Kazuki
Mori, Masahide
Miyanaga, Akihiko
Hayashi, Anna
Tanaka, Hisashi
Honda, Ryoichi
Nojiri, Masafumi
Sato, Yuki
Hata, Akito
Masuda, Ken
Kozuki, Toshiyuki
Kawamura, Takahisa
Suzuki, Takuji
Yamaguchi, Teppei
Asada, Kazuhiro
Tetsumoto, Satoshi
Tanaka, Hiroshi
Watanabe, Satoshi
Umeda, Yukihiro
Yamaguchi, Kakuhiro
Kuyama, Shoichi
Tsuruno, Kosuke
Misumi, Yuki
Kuraishi, Hiroshi
Yoshihara, Ken
Nakao, Akira
Kubo, Akihito
Yokoyama, Toshihiko
Watanabe, Kana
Seki, Nobuhiko
Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title_full Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title_fullStr Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title_full_unstemmed Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title_short Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study
title_sort multicenter, retrospective study to evaluate necitumumab plus cisplatin and gemcitabine after immune checkpoint inhibitors in advanced squamous cell lung cancer in japan: the ninja study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10689269/
https://www.ncbi.nlm.nih.gov/pubmed/38046378
http://dx.doi.org/10.1016/j.jtocrr.2023.100593
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