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.

Additional Metadata
Keywords Cytokines, Melanoma, Peginterferon alfa-2b, Pharmacokinetics
Persistent URL dx.doi.org/10.1007/s00280-009-1072-z, hdl.handle.net/1765/27910
Citation
Eggermont, A.M.M., Bouwhuis, M.G., Kruit, W.H.J., Testori, A., ten Hagen, T.L.M., Yver, A., & Xu, C.. (2010). 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). Cancer Chemotherapy and Pharmacology, 65(4), 671–677. doi:10.1007/s00280-009-1072-z