Original Article

Cancer Chemotherapy and Pharmacology

, Volume 65, Issue 4, pp 671-677

First online:

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. EggermontAffiliated withDepartment of Surgical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center Email author 
  • , Marna G. BouwhuisAffiliated withDepartment of Surgical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center
  • , Wim H. KruitAffiliated withDepartment of Medical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center
  • , Alessandro TestoriAffiliated withMelanoma/Sarcoma Unit, European Institute of Oncology
  • , Timo ten HagenAffiliated withDepartment of Surgical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center
  • , Antoine YverAffiliated withSchering-Plough Research Institute
  • , Christine XuAffiliated withSchering-Plough Research Institute

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

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