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

doi:10.1007/s00280-009-1072-z

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

Istituto Europeo di Oncologia

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	671-677
Number of pages	7
Journal	Cancer Chemotherapy and Pharmacology
Volume	65
Issue number	4
DOIs	https://doi.org/10.1007/s00280-009-1072-z
Publication status	Published - Mar 2010

Keywords

Cytokines
Melanoma
Peginterferon alfa-2b
Pharmacokinetics

ASJC Scopus subject areas

Cancer Research
Oncology
Pharmacology
Pharmacology (medical)
Toxicology

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Eggermont, A. M. M., Bouwhuis, M. G., Kruit, W. H., Testori, A., Ten Hagen, T., 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. https://doi.org/10.1007/s00280-009-1072-z

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

In: Cancer Chemotherapy and Pharmacology, Vol. 65, No. 4, 03.2010, p. 671-677.

Research output: Contribution to journal › Article › peer-review

Eggermont, AMM, Bouwhuis, MG, Kruit, WH, Testori, A, Ten Hagen, T, 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, vol. 65, no. 4, pp. 671-677. https://doi.org/10.1007/s00280-009-1072-z

Eggermont, Alexander M M ; Bouwhuis, Marna G. ; Kruit, Wim H. ; Testori, Alessandro ; Ten Hagen, Timo ; Yver, Antoine ; Xu, Christine. / 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). In: Cancer Chemotherapy and Pharmacology. 2010 ; Vol. 65, No. 4. pp. 671-677.

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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.",

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