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Wanted to share Median overall and relapse-free survivals were not reached after a median follow-up of 29.5 months
Authors' Affiliations: Departments of Cutaneous Oncology and Biostatistics, Moffitt Cancer Center, Tampa, Florida; Departments of Medicine and Preventive Medicine, Keck/USC School of Medicine, Los Angeles, California, Cedars-Sinai Medical Center, Los Angeles, California; and Medarex, Inc, Annandale, New Jersey.
PURPOSE: To determine safety and feasibility of adjuvant ipilimumab following resection of high-risk melanoma and to identify surrogate markers for benefit.
EXPERIMENTAL DESIGN: In this phase II trial, 75 patients with resected stage IIIc/IV melanoma received the CTLA-4 antibody ipilimumab every 6 to 8 weeks for 1 year. Eligible patients received further maintenance treatments. The first 25 patients received 3 mg/kg of ipilimumab, and an additional 50 patients received 10 mg/kg. HLA-A*0201+ patients received multipeptide immunizations in combination with ipilimumab. Leukapheresis was performed prior to and 6 months after initiation of treatment.
RESULTS: Median overall and relapse-free survivals were not reached after a median follow-up of 29.5 months. Significant immune-related adverse events were observed in 28 of 75 patients and were positively associated with longer relapse-free survival. Antigen-specific T cell responses to vaccine were variable, and vaccine combination was not associated with additional benefit. No effects on T regulatory cells were observed. Higher changes in Th-17 inducible frequency were a surrogate marker of freedom from relapse (P = 0.047), and higher baseline C-reactive protein (CRP) levels were associated with freedom from relapse (P = 0.035).
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