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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In that analysis, patients who experienced IRAEs had prolonged OS compared to those who did not (16.8 vs 3.2 months; HR .17, p < .001).
“and OS (16.8 vs 3.2 months (HR .17, p < .001)) compared to patients who did not experience them.”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [43]
In that analysis, patients who experienced IRAEs had prolonged PFS compared to those who did not (7.5 vs 1.4 months; HR .11, p < .001).
“Patients who experienced IRAEs had prolonged PFS (7.5 vs 1.4 months (HR .11, p < .001))”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [43]
In a retrospective analysis of 65 gastric cancer patients treated with nivolumab, 21.5% developed IRAEs.
“Of 65 patients, 21.5% developed IRAEs with the most common site of involvement being gastrointestinal (35.7%).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [43]
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- Authors
- Masuda, K., Shoji, H., Nagashima, K., Yamamoto, S., Ishikawa, M., Imazeki, H., Aoki, M., Miyamoto, T., Hirano, H., Honma, Y., Iwasa, S., Okita, N., Takashima, A., Kato, K., & Boku, N.
- Affiliations
- National Cancer Center Hospital (JP)
- Chiba University (JP)
- National Cancer Hospital, Tokyo, Japan;
- Department of Cancer Chemotherapy Center, Osaka Medical Collage Hospital, Osaka, Japan;
- National Cancer Centre Japan (JP)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2019-05-20
- Volume
- 37
- Issue
- 15_suppl
- Pages
- 4049-4049
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2947893849
- Cited by
- 20
- References
- 0
- Citations by year
- 2025: 1 · 2023: 2 · 2022: 8 · 2021: 5 · 2020: 3 · 2019: 1
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Ferroptosis and cancer prognosis
- Keywords
- immune-related adverse events, nivolumab, advanced gastric cancer, immune checkpoint inhibitors, prognosis, progression-free survival, overall survival, serum alkaline phosphatase, predictive biomarkers, immune-related pneumonitis, immune-related colitis, immune-related dermatitis, immune-related endocrinopathy, immune-related encephalitis, immune-related hepatitis, immune-related nephritis, immune-related hypophysitis
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