Cancer Chemotherapy and Pharmacology

, Volume 65, Issue 4, pp 671–677

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
Original Article
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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.

Keywords

Peginterferon alfa-2b Melanoma Pharmacokinetics Cytokines 

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Alexander M. M. Eggermont
    • 1
  • Marna G. Bouwhuis
    • 1
  • Wim H. Kruit
    • 2
  • Alessandro Testori
    • 3
  • Timo ten Hagen
    • 1
  • Antoine Yver
    • 4
  • Christine Xu
    • 4
  1. 1.Department of Surgical OncologyErasmus University Medical Center, Daniel den Hoed Cancer CenterRotterdamThe Netherlands
  2. 2.Department of Medical OncologyErasmus University Medical Center, Daniel den Hoed Cancer CenterRotterdamThe Netherlands
  3. 3.Melanoma/Sarcoma UnitEuropean Institute of OncologyMilanItaly
  4. 4.Schering-Plough Research InstituteKenilworthUSA

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