Takayuki Ando1, Akira Ueda2, Kohei Ogawa3, Iori Motoo4, Shinya Kajiura4, Takahiko Nakajima5, Katsuhisa Hirano6, Tomoyuki Okumura6, Kenichiro Tsukada7, Takuo Hara8, Nobuhiro Suzuki9, Naokatsu Nakada10, Naoki Horikawa11, Tsutomu Fujii6, Ichiro Yasuda4. 1. Third Department of Internal Medicine, University of Toyama, Toyama, Japan; taando33@gmail.com. 2. Department of Medical Oncology, Toyama Red Cross Hospital, Toyama, Japan. 3. Department of Medical Oncology, Toyama Prefectural Central Hospital, Toyama, Japan. 4. Third Department of Internal Medicine, University of Toyama, Toyama, Japan. 5. Department of Diagnostic Pathology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan. 6. Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan. 7. Department of Gastroenterology, Kouseiren Takaoka Hospital, Takaoka, Japan. 8. Department of Surgery, Kouseiren Takaoka Hospital, Takaoka, Japan. 9. Department of Gastroenterology, Joetsu General Hospital, Joetsu, Japan. 10. Itoigawa Community Medical Unit, Toyama University Hospital, Itoigawa, Japan. 11. Department of Surgery, Takaoka City Hospital, Takaoka, Japan.
Abstract
BACKGROUND: Immune-checkpoint inhibitors (ICI), including nivolumab and pembrolizumab, are among the standard treatments for previously treated advanced gastric cancer (AGC). This study aimed to evaluate the frequency of immune-related adverse events (irAEs) and the correlation between irAEs and their efficacy in AGC cases. PATIENTS AND METHODS: Patients were divided into two groups according to irAE occurrence. The frequency of irAEs and the treatment outcome (response rate [RR], progression-free survival [PFS], and overall survival [OS]) were evaluated. The survival rates were evaluated by landmark analysis considering lead-time bias. RESULTS: Among 108 patients who received nivolumab or pembrolizumab, 17 (15.7%) had irAEs. In a 4-week landmark analysis, the RR, median PFS, and median OS were 28.5%, 3.9 months (95% CI=2.8-9.3), and 12.2 months (95% CI=3.8-NA) in patients with irAEs, while 3.0% (2/65), 1.8 months (95% CI=1.4-2.1), and 3.5 months (95% CI, 2.9-5.1) in patients without irAEs, respectively. In multivariate analysis, irAEs were associated with better PFS (HR=2.08, 95% CI=1.34-3.21). CONCLUSION: The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC. Copyright
BACKGROUND: Immune-checkpoint inhibitors (ICI), including nivolumab and pembrolizumab, are among the standard treatments for previously treated advanced gastric cancer (AGC). This study aimed to evaluate the frequency of immune-related adverse events (irAEs) and the correlation between irAEs and their efficacy in AGC cases. PATIENTS AND METHODS: Patients were divided into two groups according to irAE occurrence. The frequency of irAEs and the treatment outcome (response rate [RR], progression-free survival [PFS], and overall survival [OS]) were evaluated. The survival rates were evaluated by landmark analysis considering lead-time bias. RESULTS: Among 108 patients who received nivolumab or pembrolizumab, 17 (15.7%) had irAEs. In a 4-week landmark analysis, the RR, median PFS, and median OS were 28.5%, 3.9 months (95% CI=2.8-9.3), and 12.2 months (95% CI=3.8-NA) in patients with irAEs, while 3.0% (2/65), 1.8 months (95% CI=1.4-2.1), and 3.5 months (95% CI, 2.9-5.1) in patients without irAEs, respectively. In multivariate analysis, irAEs were associated with better PFS (HR=2.08, 95% CI=1.34-3.21). CONCLUSION: The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC. Copyright
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