Trial reportJournal for immunotherapy of cancer2021
Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis.
Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 6 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Sex, Timing, and Outcomes of Curative-Intent Immunotherapy: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- Safety of immune checkpoint modulators beyond PD-1/PD-L1 and CTLA-4 in solid tumors: a meta-analysis.JNCI cancer spectrum · 2026Pooled it
- Immune-related adverse events with cancer clinical benefits: a systematic review and meta-analysis.BMC cancer · 2026Pooled it
- Association of CirAEs and Efficacy in NSCLC Patients Treated with PD-1/PD-L1: A Meta-analysis of Cohort Studies.Combinatorial chemistry & high throughput screening · 2025Pooled it
- Immune checkpoint inhibitors-associated cranial nerves involvement: a systematic literature review on 136 patients.Journal of neurology · 2024Pooled it
- Patients with melanoma treated with immune checkpoint inhibitors who had non-thyroid endocrine and skin immune-related adverse events have better prognosis: A systematic review and meta-analysis.Frontiers in oncology · 2022Pooled it
- Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis.Journal for immunotherapy of cancer · 2021Trial
- Predicting immune-related thyroiditis using polygenic risk scores in patients with advanced melanoma.Journal for immunotherapy of cancer · 2026Article
- Associations between Immune-related Adverse Events and Prognosis in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy.Internal medicine (Tokyo, Japan) · 2026Review
- Application of Immune Checkpoint Inhibitors in Cancer.MedComm · 2025Review
- Immunotherapy-associated hemostatic abnormalities: bleeding and thrombotic complications.Annals of hematology · 2025Review
- Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma in Older Patients: An Overview of Published Data.Cancers · 2025Review
- First cycle toxicity and survival in patients with rare cancers treated with checkpoint inhibitors.Journal of the National Cancer Institute · 2025Article
- Case Report and Literature Review on Skin Toxicity Induced by PD-1 Inhibitor in a Penile Cancer with Massive Ulceration of Chemoradiotherapy-Resistant and Successful Treatment by Immunotherapy.Clinical, cosmetic and investigational dermatology · 2025Article
- Cutaneous adverse events associated with the efficacy and benefit of immune checkpoint inhibitors: a systematic review and meta-analysis.Frontiers in oncology · 2025Article
- Identification of a prognostic signature based on immunogenic adverse event-related genes to guide therapy for non-small cell lung cancer.Frontiers in immunology · 2025Article
- Near-infrared duocarmycin photorelease from a Treg-targeted antibody-drug conjugate improves efficacy of PD-1 blockade in syngeneic murine tumor models.Oncoimmunology · 2024Article
- Immunotherapy in oncology and the kidneys: a clinical review of the evaluation and management of kidney immune-related adverse events.Clinical kidney journal · 2023Review
- Immunosuppression for immune-related adverse events during checkpoint inhibition: an intricate balance.NPJ precision oncology · 2023Review
- Review
Corrections and comments
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Authors and funding
21 authors at 17 institutions in 1 country.
Funding
Abstract
backgroundThe impact of immune-related adverse events (irAEs) occurring from adjuvant use of immunotherapy and of their management on relapse-free survival (RFS) and overall survival (OS) outcomes is currently not well understood. PATIENTS AND
methodsE1609 enrolled 1673 patients with resected high-risk melanoma and evaluated adjuvant ipilimumab 3 mg/kg (ipi3) and 10 mg/kg (ipi10) versus interferon-α. We investigated the association of irAEs and of use of immunosuppressants with RFS and OS for patients treated with ipilimumab (n=1034).
resultsOccurrence of grades 1-2 irAEs was associated with RFS (5 years: 52% (95% CI 47% to 56%) vs 41% (95% CI 31% to 50%) with no AE; p=0.006) and a trend toward improved OS (5 years: 75% (95% CI 71% to 79%) compared with 67% (95% CI 56% to 75%) with no AE; p=0.064). Among specific irAEs, grades 1-2 rash was most significantly associated with RFS (p=0.002) and OS (p=0.003). In multivariate models adjusting for prognostic factors, the most significant associations were seen for grades 1-2 rash with RFS (p<0.001, HR=0.70) and OS (p=0.01, HR=0.71) and for grades 1-2 endocrine+rash with RFS (p<0.001, HR=0.66) and OS (p=0.008, HR=0.7). Overall, grades 1-2 irAEs had the best prognosis in terms of RFS and OS and those with grades 3-4 had less RFS benefits and no OS advantage over no irAE. Patients experiencing grades 3-4 irAE had significantly higher exposure to corticosteroids and immunosuppressants than those with grades 1-2 (92% vs 60%; p<0.001), but no significant associations were found between corticosteroid and immunosuppressant use and RFS or OS. In investigating the impact of non-corticosteroid immunosuppressants, although there were trends toward better RFS and OS favoring cases who were not exposed, no significant associations were found.
conclusionsRash and endocrine irAEs were independent prognostic factors of RFS and OS in patients treated with adjuvant ipilimumab. Patients experiencing lower grade irAEs derived the most benefit, but we found no significant evidence supporting a negative impact of high dose corticosteroids and immunosuppressants more commonly used to manage grades 3-4 irAEs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.