2021
Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis
Tarhini AA, Kang N, Lee SJ, Hodi FS, Cohen GI, Hamid O, Hutchins LF, Sosman JA, Kluger HM, Eroglu Z, Koon HB, Lawrence DP, Kendra KL, Minor DR, Lee CB, Albertini MR, Flaherty LE, Petrella TM, Streicher H, Sondak VK, Kirkwood JM. 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 2021, 9: e002535. PMID: 33963015, PMCID: PMC8108687, DOI: 10.1136/jitc-2021-002535.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsRelapse-free survivalUse of immunosuppressantsAdjuvant ipilimumabGrade 3Grade 1Significant associationAdverse eventsPrognostic factorsSpecific immune-related adverse eventsTerms of RFSEndocrine immune-related adverse eventsBetter relapse-free survivalHigh-dose corticosteroidsImmune adverse eventsHigh-risk melanomaIndependent prognostic factorOverall survival outcomesDose corticosteroidsImmunosuppressant useRFS benefitsImproved OSBetter prognosisAdjuvant useSurvival outcomes
2019
United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma.
Tarhini A, Lee S, Hodi F, Rao U, Cohen G, Hamid O, Hutchins L, Sosman J, Kluger H, Sondak V, Koon H, Lawrence D, Kendra K, Minor D, Lee C, Albertini M, Flaherty L, Petrella T, Kirkwood J. United States Intergroup E1609: A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-α2b for resected high-risk melanoma. Journal Of Clinical Oncology 2019, 37: 9504-9504. DOI: 10.1200/jco.2019.37.15_suppl.9504.Peer-Reviewed Original ResearchRelapse-free survivalHigh-risk melanomaOverall survivalAdjuvant therapyAdverse events grade 3High-dose interferon-α2bPhase III adjuvant trialActive control regimenMelanoma adjuvant therapySystemic adjuvant therapySignificant OS differenceCo-primary endpointsAdjuvant ipilimumabAdjuvant standardRFS benefitsAdjuvant trialsTreatment discontinuationData cutoffPrimary endpointITT analysisPatient accrualControl regimenProtocol criteriaGrade 3OS difference