Format

Send to

Choose Destination
Pediatr Blood Cancer. 2016 Jul;63(7):1207-13. doi: 10.1002/pbc.25983. Epub 2016 Apr 1.

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

Author information

1
Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
2
Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee.
3
Division of Pediatrics, MD Anderson Cancer Center, Houston, Texas.
4
Department of Surgery, St. Jude Children's Research Hospital, Memphis, Tennessee.
5
Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
6
Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
7
Department of Nursing Research, St. Jude Children's Research Hospital, Memphis, Tennessee.
8
Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
9
Department of Pediatric Medicine, Division of Endocrinology, St. Jude Children's Research Hospital, Memphis, Tennessee.
10
Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
11
Department of Radiological Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
12
Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee.
13
Department of Pediatrics, University of California-San Diego, La Jolla, California.

Abstract

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/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).

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.

KEYWORDS:

adjuvant therapy; childhood; high risk; melanoma; pegylated interferon; pharmacokinetics

PMID:
27038395
PMCID:
PMC4877209
DOI:
10.1002/pbc.25983
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center