Higher-Dose Adjuvant Ipilimumab More Toxic, Does Not Improve Recurrence-Free Survival
Researchers examined the number of treatment-related adverse events related to ipilimumab dosage.
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CHICAGO — Adjuvant ipilimumab therapy for resected high-risk melanoma at a dose of 10 mg/kg is associated with significantly more toxicity than a dose of 3 mg/kg and does not improve recurrence-free survival (RFS), according to study findings presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
In a phase III randomized trial (E1609), the ipilimumab 10 mg/kg dose (ipi10) was associated with higher rates of treatment-related adverse events (AEs) and discontinuation of treatment, lead investigator Ahmad A. Tarhini, MD, PhD, of the University of Pittsburgh Cancer Institute, told listeners.
Investigators randomly assigned 1670 patients to receive ipilimumab 3 mg/kg (ipi3; 523 patients), ipilimumab 10 mg/kg (ipi10; 511 patients), or high-dose interferon-alfa (636 patients). Treatment-related adverse events (AEs) were reported among 503 and 516 patients in the ipi10 and ipi3 groups, respectively. Grade 3 or higher treatment-related AEs were experienced by 57% of the ipi10 patients compared with 36.4% of the ipi3 patients. AEs led to discontinuation of treatment in 271 (53.8%) of 503 ipi10 patients vs 180 (35.2%) of 512 ipi3 patients during the initial 4-dose induction phase. At a median follow-up of 3.1 years, an unplanned exploratory analysis of concurrently randomized patients revealed no significant difference in RFS for ipi10 and ipi3, Dr Tarhini told attendees. The 3-year RFS rate was 54% (95% CI, 49-60) with ipi10 and 56% (95% CI, 50-61) with ipi3.
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Tarhini AA, Lee SJ, Hodi FS, et al. A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): preliminary safety and efficacy of the ipilimumab arms. Oral presentation at: 2017 American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL.