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Correlation between immune-related adverse events and prognosis in patients with gastric cancer treated with nivolumab.

Abstract

4049
Background: Recent studies have shown that immune-related adverse events (irAEs) caused by immune checkpoint inhibitors were associated with clinical benefit in patients with melanoma or lung cancer. In advanced gastric cancer (AGC) patients, there have been few reports about the correlation between irAEs and efficacy of immune checkpoint inhibitors. Therefore, in this study, we retrospectively investigated the correlation between irAEs and efficacy in AGC patients treated with nivolumab. Methods: The subjects of this study were AGC patients that had received nivolumab monotherapy between January 2015 and August 2018. IrAEs were defined as those AEs having a potential immunological basis that required close follow-up, or immunosuppressive therapy and/or endocrine therapy. We divided the patients who received nivolumab into two groups based on occurrence of irAEs; those with irAEs (irAE group) or those without (non-irAE group). We assessed the efficacy in both groups. Results: Of the 65 AGC patients that received nivolumab monotherapy, 14 developed irAEs. The median time to onset of irAEs was 30.5 days (range 3–407 days). Median follow-up period for survivors was 32 months (95% CI, 10.8 to 34.5). The median progression-free survival was 7.5 months (95% CI, 3.6 to 11.5) in the irAE group and 1.4 months (95% CI, 1.2 to 1.6) in the non-irAE group (HR = 0.11, p < 0.001). The median overall survival was 16.8 months (95% CI, 4.4 to not reached) in the irAE group and 3.2 months (95% CI, 2.2 to 4.1) in the non-irAE group (HR = 0.17, p < 0.001). Multivariate analysis demonstrated that high ALP level (HR = 2.88; 95% CI, 1.51 to 5.51) and absence of irAEs (HR = 3.06, 95% CI, 3.06 to 23.46 for yes vs. no) were associated with a poor prognosis. The most frequent irAEs was diarrhea/colitis (n = 5). Grade 3 adverse events were observed in 6 patients; hyperglycemia (n = 2), diarrhea/colitis (n = 1), adrenal insufficiency (n = 1), increased aspartate aminotransferase increased (n = 1), peripheral motor neuropathy (n = 1). One of the 14 patients experienced the irAE after discontinuation of nivolumab due to progression of disease. There were no grade 4 or 5 adverse events related to nivolumab. Conclusions: Development of irAEs was associated with clinical benefit for AGC patients receiving nivolumab monotherapy.

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Journal of Clinical Oncology
Pages: 4049

History

Published in print: May 20, 2019
Published online: May 26, 2019

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Ken Masuda
National Cancer Center Hospital, Tokyo, Japan;
Hirokazu Shoji
Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;
Kengo Nagashima
Department of Global Clinical Research, Graduate School of Medicine, Chiba University, Chiba, Japan;
Shun Yamamoto
National Cancer Hospital, Tokyo, Japan;
Masashi Ishikawa
National Cancer Center Hospital, Tokyo, Japan;
Hiroshi Imazeki
Division of Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Japan, Tokyo, Japan;
Masahiko Aoki
Department of Cancer Chemotherapy Center, Osaka Medical Collage Hospital, Osaka, Japan;
Takahiro Miyamoto
Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan;
Hidekazu Hirano
National Cancer Center Hospital, Tokyo, Japan;
Yoshitaka Honma
Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;
Satoru Iwasa
Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan;
Natsuko Okita
National Cancer Center Hospital East, Tokyo, Japan;
Atsuo Takashima
Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;
Ken Kato
Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;
Narikazu Boku
National Cancer Center Hospital, Tokyo, Japan;
National Cancer Center Hospital, Tokyo, Japan; Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Global Clinical Research, Graduate School of Medicine, Chiba University, Chiba, Japan; National Cancer Hospital, Tokyo, Japan; Division of Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Japan, Tokyo, Japan; Department of Cancer Chemotherapy Center, Osaka Medical Collage Hospital, Osaka, Japan; Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan; Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan; National Cancer Center Hospital East, Tokyo, Japan; Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

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Ken Masuda, Hirokazu Shoji, Kengo Nagashima, Shun Yamamoto, Masashi Ishikawa, Hiroshi Imazeki, Masahiko Aoki, Takahiro Miyamoto, Hidekazu Hirano, Yoshitaka Honma, Satoru Iwasa, Natsuko Okita, Atsuo Takashima, Ken Kato, Narikazu Boku
Journal of Clinical Oncology 2019 37:15_suppl, 4049-4049

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