title: Feasibility of Pegylated Interferon in Children and Young Adults With Resected High-Risk Melanoma.
abstract: 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.
  
  
  
  Eligible patients with resected American Joint Committee on Cancer Stage IIC, IIIA, and IIIB cutaneous melanoma received nonpegylated IFN α-2b 20 million units/m(2) /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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Fariba
authors.initials: F
authors.lastname: Navid
authors.affiliation: Division of Pediatrics, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Cynthia E
authors.initials: CE
authors.lastname: Herzog
authors.affiliation: Department of Surgery, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: John
authors.initials: J
authors.lastname: Sandoval
authors.affiliation: Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Vinay M
authors.initials: VM
authors.lastname: Daryani
authors.affiliation: Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Clinton F
authors.initials: CF
authors.lastname: Stewart
authors.affiliation: Department of Nursing Research, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Jami
authors.initials: J
authors.lastname: Gattuso
authors.affiliation: Department of Nursing Research, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Belinda
authors.initials: B
authors.lastname: Mandrell
authors.affiliation: Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Sean
authors.initials: S
authors.lastname: Phipps
authors.affiliation: Department of Pediatric Medicine, Division of Endocrinology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Wassim
authors.initials: W
authors.lastname: Chemaitilly
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: April
authors.initials: A
authors.lastname: Sykes
authors.affiliation: Department of Surgery, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Davidoff
authors.affiliation: Department of Radiological Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Barry L
authors.initials: BL
authors.lastname: Shulkin
authors.affiliation: Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Armita
authors.initials: A
authors.lastname: Bahrami
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Furman
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Shenghua
authors.initials: S
authors.lastname: Mao
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Jianrong
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Pediatrics, University of California-San Diego, La Jolla, California.
authors.forename: Deborah
authors.initials: D
authors.lastname: Schiff
authors.affiliation: Department of Surgery, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Bhaskar
authors.initials: B
authors.lastname: Rao
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pappo
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b
keywords: adjuvant therapy; childhood; high risk; melanoma; pegylated interferon; pharmacokinetics