Feasibility of Pegylated Interferon in Children and Young Adults With Resected High-Risk Melanoma

Fariba Navid, Cynthia E. Herzog, John Sandoval, Vinay M. Daryani, Clinton F. Stewart, Jami Gattuso, Belinda Mandrell, Sean Phipps, Wassim Chemaitilly, April Sykes, Andrew M. Davidoff, Barry L. Shulkin, Armita Bahrami, Wayne L. Furman, Shenghua Mao, Jianrong Wu, Deborah Schiff, Bhaskar Rao, Alberto Pappo

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Background: Pegylated interferon α-2b (IFN α-2b) improves disease-free survival in adults with resected stage III melanoma. We conducted a study to determine the feasibility and safety of incorporating pegylated IFN α-2b as adjuvant therapy in the treatment of children and adolescents with high-risk melanoma. Pharmacokinetic studies of IFN α-2b and neuropsychological and quality of life (OL) assessments were performed. Patient and Methods: Eligible patients with resected American Joint Committee on Cancer Stage IIC, IIIA, and IIIB cutaneous melanoma received nonpegylated IFN α-2b 20 million units/m2/day intravenously 5 days per week for 4 weeks (induction) followed by pegylated IFN α-2b 1 μg/kg/dose weekly subcutaneously (SQ) for 48 weeks (maintenance). Results: Twenty-three patients (15 females, median age 10 years) were enrolled. All patients completed induction therapy; five patients did not complete maintenance therapy either because of recurrent disease (n = 2) or toxicity (n = 3). The most common grade 3 and 4 toxicities of pegylated IFN α-2b were neutropenia (35%) and elevated liver transaminases (17%). The median nonpegylated IFN α-2b AUC0-∞ (5,026 pcg⋅hr/ml) was similar to adults. The median pegylated IFN α-2b exposure (48,480 pcg⋅hr/ml) was greater than the cumulative weekly exposure for nonpegylated IFN α-2b administered SQ three times per week (TIW). Validated measures demonstrated an improvement in QOL scores and no decline in psychological functioning over the course of therapy. Conclusions: Pegylated IFN α-2b 1 μg/kg/dose SQ weekly as maintenance therapy in children and adolescents with high-risk melanoma is feasible with tolerable toxicity and appears to yield higher exposures than nonpegylated IFN α-2b administered SQ TIW.

Original languageEnglish
Pages (from-to)1207-1213
Number of pages7
JournalPediatric Blood and Cancer
Issue number7
StatePublished - Jul 1 2016

Bibliographical note

Funding Information:
Cancer Center Support CORE from the National Cancer Institute; Grant number: P30 CA 21765; Grant sponsor: American Lebanese Syrian Associated Charities; Grant sponsor: Schering-Plough/Merck, Inc.

Publisher Copyright:
© 2016 Wiley Periodicals, Inc.


  • Adjuvant therapy
  • Childhood
  • High risk
  • Melanoma
  • Pegylated interferon
  • Pharmacokinetics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology


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