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. 2023 Oct 20;4(12):100593.
doi: 10.1016/j.jtocrr.2023.100593. eCollection 2023 Dec.

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

Yasunori Murata  1 , Shigeru Tanzawa  2 , Toshihiro Misumi  3 , Hiroshige Yoshioka  4 , Eisaku Miyauchi  5 , Kiichiro Ninomiya  6 , Masafumi Takeshita  1 , Kensaku Ito  7 , Tatsuro Okamoto  7 , Shunichi Sugawara  8 , Yosuke Kawashima  8 , Kazuki Hashimoto  9 , Masahide Mori  9 , Akihiko Miyanaga  10 , Anna Hayashi  10 , Hisashi Tanaka  11 , Ryoichi Honda  12 , Masafumi Nojiri  13 , Yuki Sato  14 , Akito Hata  15 , Ken Masuda  16 , Toshiyuki Kozuki  17 , Takahisa Kawamura  18 , Takuji Suzuki  19 , Teppei Yamaguchi  20 , Kazuhiro Asada  21 , Satoshi Tetsumoto  22 , Hiroshi Tanaka  23 , Satoshi Watanabe  24 , Yukihiro Umeda  25 , Kakuhiro Yamaguchi  26 , Shoichi Kuyama  27 , Kosuke Tsuruno  28 , Yuki Misumi  29 , Hiroshi Kuraishi  30 , Ken Yoshihara  31 , Akira Nakao  32 , Akihito Kubo  33 , Toshihiko Yokoyama  34 , Kana Watanabe  35 , Nobuhiko Seki  2
Affiliations

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

Yasunori Murata et al. JTO Clin Res Rep. .

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.

Keywords: Immune checkpoint inhibitor; Lung squamous cell carcinoma; Necitumumab; Platinum rechallenge; Skin disorder.

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Figures

Figure 1
Figure 1
Patient recruitment and follow-up flow diagram. GCN, gemcitabine and cisplatin plus necitumumab.
Figure 2
Figure 2
The Kaplan-Meier curves of PFS (A) and OS (B) in the full analysis set. PFS, progression-free survival; OS, overall survival; CI, confidence interval.
Figure 3
Figure 3
The Kaplan-Meier curves of PFS (A) and OS (B) by grade of skin disorders. PFS, progression-free survival; OS, overall survival; CI, confidence interval; NE, not evaluated.
See this image and copyright information in PMC

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