PURPOSE: The EORTC 18991 trial assessed the effect of long-term adjuvant pegylated interferon (Peg-IFN) alpha-2b administered weekly in patients with lymph node-positive melanoma. Serum concentrations were analyzed to determine exposure to Peg-IFN alpha-2b. METHODS: After surgery, patients were randomized to receive Peg-IFN alpha-2b or to observation only. The treatment group received 6 microg/kg/week Peg-IFN alpha-2b subcutaneously for 8 weeks, followed by a maintenance dose of 3 microg/kg/week for up to 5 years. Blood samples were collected between months 3 and 60. RESULTS:A total of 208 Peg-IFN alpha-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 alpha-2b was sustained during long-term adjuvant treatment with Peg-IFN alpha-2b in patients with melanoma, consistent with the EORTC 18991 trial's conclusion of a significant, sustained, and relapse-free survival benefit.
RCT Entities:
PURPOSE: The EORTC 18991 trial assessed the effect of long-term adjuvant pegylated interferon (Peg-IFN) alpha-2b administered weekly in patients with lymph node-positive melanoma. Serum concentrations were analyzed to determine exposure to Peg-IFN alpha-2b. METHODS: After surgery, patients were randomized to receive Peg-IFN alpha-2b or to observation only. The treatment group received 6 microg/kg/week Peg-IFN alpha-2b subcutaneously for 8 weeks, followed by a maintenance dose of 3 microg/kg/week for up to 5 years. Blood samples were collected between months 3 and 60. RESULTS: A total of 208 Peg-IFN alpha-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 alpha-2b was sustained during long-term adjuvant treatment with Peg-IFN alpha-2b in patients with melanoma, consistent with the EORTC 18991 trial's conclusion of a significant, sustained, and relapse-free survival benefit.
Authors: C Xu; S Gupta; G Krishna; D Cutler; S Wirth; C Galoppo; M Ciocca; K Kolz; S Noviello; V Sniukiene Journal: Eur J Clin Pharmacol Date: 2013-08-24 Impact factor: 2.953
Authors: Doru T Alexandrescu; Thomas E Ichim; Neil H Riordan; Francesco M Marincola; Anna Di Nardo; Filamer D Kabigting; Constantin A Dasanu Journal: J Immunother Date: 2010 Jul-Aug Impact factor: 4.456
Authors: A I Daud; C Xu; W-J Hwu; P Urbas; S Andrews; N E Papadopoulos; L C Floren; A Yver; R C Deconti; V K Sondak Journal: Cancer Chemother Pharmacol Date: 2010-05-28 Impact factor: 3.333