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 | |
| Publication status | Published - Mar 2010 |
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Keywords
- Cytokines
- Melanoma
- Peginterferon alfa-2b
- Pharmacokinetics
ASJC Scopus subject areas
- Cancer Research
- Oncology
- Pharmacology
- Pharmacology (medical)
- Toxicology
Cite this
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
}
TY - JOUR
T1 - 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)
AU - Eggermont, Alexander M M
AU - Bouwhuis, Marna G.
AU - Kruit, Wim H.
AU - Testori, Alessandro
AU - Ten Hagen, Timo
AU - Yver, Antoine
AU - Xu, Christine
PY - 2010/3
Y1 - 2010/3
N2 - 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.
AB - 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.
KW - Cytokines
KW - Melanoma
KW - Peginterferon alfa-2b
KW - Pharmacokinetics
UR - http://www.scopus.com/inward/record.url?scp=75749126964&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=75749126964&partnerID=8YFLogxK
U2 - 10.1007/s00280-009-1072-z
DO - 10.1007/s00280-009-1072-z
M3 - Article
C2 - 19621225
AN - SCOPUS:75749126964
VL - 65
SP - 671
EP - 677
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 4
ER -