JTO Clinical and Research Reports (Dec 2023)
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, 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,
- Nobuhiko Seki, MD, PhD
Affiliations
- Yasunori Murata, MD, PhD
- Department of Respiratory Medicine, Ichinomiya Nishi Hospital, Aichi, Japan
- Shigeru Tanzawa, MD, PhD
- Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan
- Toshihiro Misumi, PhD
- Department of Data Science, National Cancer Center Hospital East, Chiba, Japan
- Hiroshige Yoshioka, MD, PhD
- Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan
- Eisaku Miyauchi, MD, PhD
- Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan
- Kiichiro Ninomiya, MD, PhD
- Center for Comprehensive Genomic Medicine, Okayama University Hospital, Okayama, Japan
- Masafumi Takeshita, MD, PhD
- Department of Respiratory Medicine, Ichinomiya Nishi Hospital, Aichi, Japan
- Kensaku Ito, MD, PhD
- Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
- Tatsuro Okamoto, MD, PhD
- Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
- Shunichi Sugawara, MD, PhD
- Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan
- Yosuke Kawashima, MD
- Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan
- Kazuki Hashimoto, MD
- Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan
- Masahide Mori, MD, PhD
- Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan
- Akihiko Miyanaga, MD, PhD
- Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
- Anna Hayashi, MD
- Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
- Hisashi Tanaka, MD, PhD
- Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Aomori, Japan
- Ryoichi Honda, MD, PhD
- Department of Respiratory Medicine, Asahi General Hospital, Chiba, Japan
- Masafumi Nojiri, MD, PhD
- Department of Respiratory Medicine, Kanazawa Medical University, Ishikawa, Japan
- Yuki Sato, MD
- Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan
- Akito Hata, MD
- Division of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Hyogo, Japan
- Ken Masuda, MD, PhD
- Department of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan
- Toshiyuki Kozuki, MD, PhD
- Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Ehime, Japan
- Takahisa Kawamura, MD, PhD
- Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
- Takuji Suzuki, MD, PhD
- Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan
- Teppei Yamaguchi, MD, PhD
- Department of Thoracic Oncology, Aichi Cancer Center Hospital, Aichi, Japan
- Kazuhiro Asada, MD, PhD
- Department of Respiratory Medicine, Shizuoka General Hospital, Shizuoka, Japan
- Satoshi Tetsumoto, MD, PhD
- Department of Respiratory Medicine and Clinical Immunology, Suita Municipal Hospital, Osaka, Japan
- Hiroshi Tanaka, MD, PhD
- Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
- Satoshi Watanabe, MD, PhD
- Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
- Yukihiro Umeda, MD, PhD
- Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
- Kakuhiro Yamaguchi, MD, PhD
- Department of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan
- Shoichi Kuyama, MD, PhD
- Department of Respiratory Medicine, National Hospital Organization Iwakuni Clinical Center, Yamaguchi, Japan
- Kosuke Tsuruno, MD, PhD
- Department of Respiratory Medicine, Iizuka Hospital, Fukuoka, Japan
- Yuki Misumi, MD, PhD
- Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan
- Hiroshi Kuraishi, MD, PhD
- Department of Pulmonary Medicine, Nagano Red Cross Hospital, Nagano, Japan
- Ken Yoshihara, MD, PhD
- Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan
- Akira Nakao, MD, PhD
- Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan
- Akihito Kubo, MD, PhD
- Department of Respiratory Medicine and Allergology, Aichi Medical University, Aichi, Japan
- Toshihiko Yokoyama, MD, PhD
- Department of Respiratory Medicine, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Aichi, Japan
- Kana Watanabe, MD, PhD
- Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan
- Nobuhiko Seki, MD, PhD
- Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan; Corresponding author. Address for correspondence: Nobuhiko Seki, MD, PhD, Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan.
- Journal volume & issue
-
Vol. 4,
no. 12
p. 100593
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.
