Serum concentrations of pegylated interferon α-2b in patients with resected stage III melanoma receiving adjuvant pegylated interferon α-2b in a randomized phase III trial (EORTC 18991)

Alexander M M Eggermont, Marna G. Bouwhuis, Wim H. Kruit, Alessandro Testori, Timo Ten Hagen, Antoine Yver, Christine Xu

Research output: Contribution to journalArticle

Abstract

Purpose: The EORTC 18991 trial assessed the effect of long-term adjuvant pegylated interferon (Peg-IFN) α-2b administered weekly in patients with lymph node-positive melanoma. Serum concentrations were analyzed to determine exposure to Peg-IFN α-2b. Methods: After surgery, patients were randomized to receive Peg-IFN α-2b or to observation only. The treatment group received 6 μg/kg/week Peg-IFN α-2b subcutaneously for 8 weeks, followed by a maintenance dose of 3 μg/kg/week for up to 5 years. Blood samples were collected between months 3 and 60. Results: A total of 208 Peg-IFN α-2b concentrations from 48 patients were available. Serum trough concentrations increased in a dose-related manner. Mean dose-normalized serum concentrations and intersubject variability over the 5-year study period in patients with melanoma were similar to those observed in patients with chronic hepatitis. Conclusion: Data suggest that the exposure to Peg-IFN α-2b was sustained during long-term adjuvant treatment with Peg-IFN α-2b in patients with melanoma, consistent with the EORTC 18991 trial's conclusion of a significant, sustained, and relapse-free survival benefit.

Original languageEnglish
Pages (from-to)671-677
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume65
Issue number4
DOIs
Publication statusPublished - Mar 2010

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Keywords

  • Cytokines
  • Melanoma
  • Peginterferon alfa-2b
  • Pharmacokinetics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

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