Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Murata Y

PROVIDER: S-EPMC10689269 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

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 Y Tanzawa Shigeru S Misumi Toshihiro T Yoshioka Hiroshige H Miyauchi Eisaku E Ninomiya Kiichiro K Takeshita Masafumi M Ito Kensaku K Okamoto Tatsuro T Sugawara Shunichi S Kawashima Yosuke Y Hashimoto Kazuki K Mori Masahide M Miyanaga Akihiko A Hayashi Anna A Tanaka Hisashi H Honda Ryoichi R Nojiri Masafumi M Sato Yuki Y Hata Akito A Masuda Ken K Kozuki Toshiyuki T Kawamura Takahisa T Suzuki Takuji T Yamaguchi Teppei T Asada Kazuhiro K Tetsumoto Satoshi S Tanaka Hiroshi H Watanabe Satoshi S Umeda Yukihiro Y Yamaguchi Kakuhiro K Kuyama Shoichi S Tsuruno Kosuke K Misumi Yuki Y Kuraishi Hiroshi H Yoshihara Ken K Nakao Akira A Kubo Akihito A Yokoyama Toshihiko T Watanabe Kana K Seki Nobuhiko N

JTO clinical and research reports 20231020 12

<h4>Introduction</h4>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.<h4>Methods</h4>This multicenter, retrospective, cohort study assessed the efficacy and tolerability of GCN initiated between November 1, 2019 and March 31, 2022 as second-lin ...[more]

PMID: 38046378

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Dataset Information

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

Methods

Results

Conclusions

Publications

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.

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