Early Immune-Related Adverse Events and Association with Outcome in Advanced Non–Small Cell Lung Cancer Patients Treated with Nivolumab: A Prospective Cohort Study
Open accessAbstract
Introduction Retrospective studies have shown immune-related adverse events (irAEs) to be associated with better prognosis. However, no prospective clinical trials have been conducted, and little is known regarding the association between irAEs and the outcome of patients with NSCLC after treatment with immunotherapy.Methods We conducted a prospective cohort study of patients with advanced NSCLC who were treated with nivolumab between January and December 2016. The association between clinical outcome and irAEs 2 to 6 weeks after commencement of nivolumab treatment was investigated. IrAEs were assessed by at least three independent medical professionals.Results A total of 43 patients were enrolled, including 19 patients with irAEs 2 weeks after commencement of nivolumab treatment. Common irAEs included rash, pyrexia, and diarrhea. Programmed cell death ligand 1-positive tumor cell expression was not significantly different between patients with and without irAEs. The objective response and disease control rates were higher in patients with irAEs than in those without irAEs (37% versus 17% and 74% versus 29% [p = 0.17 and p < 0.01], respectively]). Patients with irAEs were associated with a significantly longer median progression-free survival than those without (6.4 months [95% confidence interval: 2.5-not reached] versus 1.5 months [95% confidence interval: 1.2-2.3] [p = 0.01]). These findings were comparable to those for patients with and without irAEs 6 weeks after commencement of nivolumab treatment.Conclusions Early irAEs are associated with a better outcome after treatment with immunotherapy. We predicted responses to nivolumab by using early irAEs. Further research is needed to elucidate the mechanisms of these associations.
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In a prospective study of 43 metastatic NSCLC patients treated with nivolumab, both ORR and DCR were higher in patients who experienced IRAEs at ≤2 weeks and ≤6 weeks compared to those who did not experience them.
“Both ORR and DCR were higher in patients who experienced IRAEs at ≤2 weeks and ≤ 6 weeks compared to those who did not experience them.”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [36]
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- Authors
- Teraoka, S., Fujimoto, D., Morimoto, T., Kawachi, H., Ito, M., Sato, Y., Nagata, K., Nakagawa, A., Otsuka, K., Uehara, K., Imai, Y., Ishida, K., Fukuoka, J., & Tomii, K.
- Affiliations
- Kobe City Medical Center General Hospital (JP)
- Hyogo Medical University (JP)
- Nagasaki University Hospital (JP)
- Corresponding author
- Fujimoto, Daichi
- ORCID
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2017-12
- Volume
- 12
- Issue
- 12
- Pages
- 1798-1805
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W2754877046
- Cited by
- 375
- References
- 26
- Citations by year
- 2026: 10 · 2025: 25 · 2024: 29 · 2023: 29 · 2022: 44 · 2021: 68 · 2020: 79 · 2019: 67 · 2018: 22 · 2017: 2
- FWCI
- 20.50
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thoracic Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- immune-related adverse events, nivolumab, non-small cell lung cancer, immune checkpoint inhibitors, immunotherapy response prediction, progression-free survival, PD-L1 expression, rash, fever, diarrhea, objective response rate
- MeSH terms
- Nivolumab, Aged, Aged, 80 and over, Antibodies, Monoclonal, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Middle Aged, Prospective Studies, Cohort Studies, Treatment Outcome, Programmed Cell Death 1 Receptor
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