Colitis after checkpoint blockade: a retrospective cohort study of melanoma patients requiring admission for symptom control
Open accessAbstract
BACKGROUND: Immune checkpoint inhibitors (CPIs) have revolutionized oncologic therapy but can lead to immune-related adverse events (irAEs). Corticosteroids are first-line treatment with escalation to biologic immunosuppression in refractory cases. CPI-related gastroenterocolitis (GEC) affects 20%-50% of patients receiving CPIs and can carry significant morbidity and mortality. Severe CPI-related GEC is not well-described. We present the clinical characterization of all CPI-related GEC requiring admission at a single institution. METHODS: Clinical, laboratory, radiographic, and endoscopic data were extracted from charts of all melanoma patients ≥18 years of age admitted to one institution for CPI-related GEC, from February 5, 2011 to December 13, 2016. Patients were followed until December 31, 2017 for further admissions. Survival, outcomes, and pharmaceutical-use analyses were performed. RESULTS: Median time-to-admission from initial CPI exposure was 73.5 days. Median length of stay was 4.5 days. About 50.0% required second-line immunosuppression. Readmission for recrudescence occurred in 33.3%. Common Terminology Criteria for Adverse Events (CTCAE) grade was not significantly associated with outcomes. Hypoalbuminemia (P = 0.005), relative lymphopenia (P = 0.027), and decreased lactate dehydrogenase (P = 0.026) were associated with second-line immunosuppression. There was no difference in progression-free survival (PFS) or OS (P = 0.367, 0.400) for second-line immunosuppression. Subgroup analysis showed that early corticosteroid administration (P = 0.045) was associated with decreased PFS. CONCLUSIONS: Severe CPI-related GEC typically manifests within 3 months of immunotherapy exposure. Rates of second-line immunosuppression and readmission for recrudescence were high. CTCAE grade did not capture the degree of severity in our cohort. Second-line immunosuppression was not associated with poorer oncologic outcomes; however, early corticosteroid exposure was associated with decreased PFS. Further investigation is warranted.
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Baseline CS !10 mg of prednisone or equivalent dose was associated with poor outcome in patients with NSCLC treated with PD-1 axis inhibition (odds ratio 0.42, P=0.053), progression-free survival and overall survival (hazard ratio=1.31 and 1.66, P=0.03 and <0.001, respectively).
“Importantly, baseline CS !10 mg of prednisone or equivalent dose was associated with poor outcome in patients with NSCLC treated with PD-1 axis inhibition (odds ratio 0.42, P ¼ 0.053), progression-free survival (PFS) and overall survival (hazard ratio ¼ 1.31 and 1.66, P ¼ 0.03 and <0.001, respectively).20,21”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [21]
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References 53 · Cited by 32
- Authors
- Hughes, M. S., Zheng, H., Zubiri, L., Molina, G. E., Chen, S. T., Mooradian, M. J., Allen, I. M., Reynolds, K. L., & Dougan, M.
- Affiliations
- Harvard University (US)
- Corresponding author
- Dougan, Michael
- ORCID
- Venue
- Cancer Medicine
- Publisher
- Wiley
- Published
- 2019-07-09
- Volume
- 8
- Issue
- 11
- Pages
- 4986-4999
- ISSN
- 2045-7634 (ISSN-L)
- PMC
- PMC6718531
- OpenAlex
- W2958582726
- Cited by
- 32
- References
- 53
- Citations by year
- 2025: 3 · 2024: 6 · 2023: 1 · 2022: 2 · 2021: 9 · 2020: 9 · 2019: 2
- FWCI
- 2.28
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Cancer Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (K08DK114563, P30DK043351)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- immune checkpoint inhibitors, immune-related adverse events, colitis, gastroenterocolitis, melanoma, corticosteroids, hypoalbuminemia, lymphopenia, lactate dehydrogenase, progression-free survival, hospital readmission, CTCAE grading
- MeSH terms
- Antineoplastic Agents, Immunological, Colitis, Female, Hospitalization, Humans, Male, Melanoma, Neoplasm Metastasis, Neoplasm Staging, Severity of Illness Index, Molecular Targeted Therapy, Neoplasm Grading
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