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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)

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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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Acknowledgments

This study was sponsored by the Melanoma Group of the European Organization of Research and Treatment of Cancer (EORTC) and funded by Schering-Plough, Kenilworth, NJ, USA.

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Authors and Affiliations

  1. Department of Surgical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center, 310 Groene Hilledijk, 3075 EA, Rotterdam, The Netherlands

    Alexander M. M. Eggermont, Marna G. Bouwhuis & Timo ten Hagen

  2. Department of Medical Oncology, Erasmus University Medical Center, Daniel den Hoed Cancer Center, Rotterdam, The Netherlands

    Wim H. Kruit

  3. Melanoma/Sarcoma Unit, European Institute of Oncology, Milan, Italy

    Alessandro Testori

  4. Schering-Plough Research Institute, Kenilworth, NJ, USA

    Antoine Yver & Christine Xu

Authors
  1. Alexander M. M. Eggermont
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  2. Marna G. Bouwhuis
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  3. Wim H. Kruit
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  4. Alessandro Testori
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  5. Timo ten Hagen
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  6. Antoine Yver
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  7. Christine Xu
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Correspondence to Alexander M. M. Eggermont.

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Eggermont, A.M.M., Bouwhuis, M.G., Kruit, W.H. et al. 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 Chemother Pharmacol 65, 671–677 (2010). https://doi.org/10.1007/s00280-009-1072-z

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  • DOI: https://doi.org/10.1007/s00280-009-1072-z

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