1. 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
- Author
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Yasunori Murata, MD, PhD, Shigeru Tanzawa, MD, PhD, Toshihiro Misumi, PhD, Hiroshige Yoshioka, MD, PhD, Eisaku Miyauchi, MD, PhD, Kiichiro Ninomiya, MD, PhD, Masafumi Takeshita, MD, PhD, Kensaku Ito, MD, PhD, Tatsuro Okamoto, MD, PhD, Shunichi Sugawara, MD, PhD, Yosuke Kawashima, MD, Kazuki Hashimoto, MD, Masahide Mori, MD, PhD, Akihiko Miyanaga, MD, PhD, Anna Hayashi, MD, Hisashi Tanaka, MD, PhD, Ryoichi Honda, MD, PhD, Masafumi Nojiri, MD, PhD, Yuki Sato, MD, Akito Hata, MD, Ken Masuda, MD, PhD, Toshiyuki Kozuki, MD, PhD, Takahisa Kawamura, MD, PhD, Takuji Suzuki, MD, PhD, Teppei Yamaguchi, MD, PhD, Kazuhiro Asada, MD, PhD, Satoshi Tetsumoto, MD, PhD, Hiroshi Tanaka, MD, PhD, Satoshi Watanabe, MD, PhD, Yukihiro Umeda, MD, PhD, Kakuhiro Yamaguchi, MD, PhD, Shoichi Kuyama, MD, PhD, Kosuke Tsuruno, MD, PhD, Yuki Misumi, MD, PhD, Hiroshi Kuraishi, MD, PhD, Ken Yoshihara, MD, PhD, Akira Nakao, MD, PhD, Akihito Kubo, MD, PhD, Toshihiko Yokoyama, MD, PhD, Kana Watanabe, MD, PhD, and Nobuhiko Seki, MD, PhD
- Subjects
Necitumumab ,Immune checkpoint inhibitor ,Platinum rechallenge ,Skin disorder ,Lung squamous cell carcinoma ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - 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.
- Published
- 2023
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