Nivolumab in Resected and Unresectable Metastatic Melanoma: Characteristics of Immune-Related Adverse Events and Association with Outcomes
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Abstract
Purpose: Retrospective analysis of irAEs in melanoma patients treated with nivolumab. Experimental Design: Data were pooled from 148 patients (33 resected, 115 unresectable) treated with nivolumab plus peptide vaccine or nivolumab alone every 2 weeks for 12 weeks. Patients with stable disease or regression received an additional 12-week cycle, then nivolumab alone every 12 weeks for up to 2 additional years. Frequency, grade, and characteristics of immune-related adverse events (irAE) were analyzed. A 12-week landmark survival analysis using a multivariate time-dependent Cox proportional hazard model assessed difference in overall survival (OS) in the presence or absence of irAEs. Results: IrAEs of any grade were observed in 68.2% of patients (101 of 148). Grade III/IV irAEs were infrequent: 3 (2%) had grade III rash, 2 (1.35%) had asymptomatic grade III elevation in amylase/lipase, and 2 (1.35%) had grade III colitis. A statistically significant OS difference was noted among patients with any grade of irAE versus those without (P ≤ 0.001), and OS benefit was noted in patients who reported three or more irAE events (P ≤ 0.001). Subset analyses showed statistically significant OS differences with rash [P = 0.001; HR, 0.423; 95% confidence interval (CI), 0.243–0.735] and vitiligo (P = 0.012; HR, 0.184; 95% CI, 0.036–0.94). Rash and vitiligo also correlated with statistically significant OS differences in patients with metastatic disease (P = 0.004 and P = 0.028, respectively). No significant survival differences were seen with other irAEs (endocrinopathies, colitis, or pneumonitis). Conclusions: Cutaneous irAEs are associated with improved survival in melanoma patients treated with nivolumab, and clinical benefit should be validated in larger prospective analyses. Clin Cancer Res; 22(4); 886–94. ©2015 AACR.
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Occurrence of immune-related adverse events (irAEs) is associated with better survival, as suggested by others.
“as suggested by others if there was an occurrence of irAEs [58,59,60].”
From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [60]
In a landmark analysis, immune-related adverse events were associated with better PFS.
“We observed an association between irAEs and improved PFS using a landmark analysis, in agreement with previous studies58–60, and uncovered that baseline gut microbiome composition segregated PD-1-treated patients who developed irAEs from those who did not.”
From Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1 (2022) · cites this paper as [58]
There is an overlap between autoimmune and anti-tumor immune responses.
“Interestingly, certain treatment-related auto-immune reactions such as rash and vitiligo have been shown to correlate with better disease prognosis (103), suggesting an overlap between auto-immune and anti-tumor immune responses.”
From Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations (2018) · cites this paper as [103]
Certain treatment-related autoimmune reactions such as rash and vitiligo correlate with better disease prognosis.
“Interestingly, certain treatment-related auto-immune reactions such as rash and vitiligo have been shown to correlate with better disease prognosis (103), suggesting an overlap between auto-immune and anti-tumor immune responses.”
From Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations (2018) · cites this paper as [103]
Development of vitiligo is associated with improved objective response rates and overall survival in melanoma patients treated with immune checkpoint inhibitors.
“Several studies have shown an association between development of vitiligo and improved objective response rates and overall survival in patients with melanoma (124-126).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [124]
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- Authors
- Freeman-Keller, M., Kim, Y., Cronin, H., Richards, A., Gibney, G., & Weber, J. S.
- Affiliations
- University of South Florida (US)
- 2Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
- Moffitt Cancer Center (US)
- 4Department of Cutaneous Oncology, Lombardi Comprehensive Cancer Center, Washington, DC.
- Corresponding author
- Freeman-Keller, Morganna
- Venue
- Clinical Cancer Research
- Published
- 2016-02-14
- Volume
- 22
- Issue
- 4
- Pages
- 886-894
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC4755809
- OpenAlex
- W2179179825
- Cited by
- 863
- References
- 50
- Citations by year
- 2026: 27 · 2025: 45 · 2024: 70 · 2023: 89 · 2022: 77 · 2021: 128 · 2020: 124 · 2019: 122 · 2018: 84 · 2017: 59 · 2016: 36 · 2015: 1
- FWCI
- 26.02
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- The Donald A Adam Comprehensive Melanoma Research Center, NCI Cancer Center Support Grant, NCI (RO1CA129594,FDARO1FD-003511, P30 CA076292)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- nivolumab, immune-related adverse events, metastatic melanoma, cutaneous immune-related adverse events, rash, vitiligo, overall survival, peptide vaccine, immune checkpoint inhibitors, resected melanoma, unresectable melanoma
- MeSH terms
- Nivolumab, Antibodies, Monoclonal, Antineoplastic Agents, Exanthema, Humans, Hypothyroidism, Melanoma, Pneumonia, Skin Neoplasms, Multivariate Analysis, Proportional Hazards Models, Treatment Outcome, Mucositis, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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