title: The feasibility of adjuvant interferon alpha-2b in children with high-risk melanoma.
abstract: BACKGROUND
  It has been shown that induction high-dose interferon alpha-2b (IFN-alpha-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes.
  
  
  METHODS
  Fifteen patients age <or=18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU/m2 per day IFN-alpha-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-alpha-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence.
  
  
  RESULTS
  All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3-4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3-4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity.
  
  
  CONCLUSIONS
  High dose IFN-alpha-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity.
authors.affiliation: Department of Hematology/Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee 38105, USA. fariba.navid@stjude.org
authors.forename: Fariba
authors.initials: F
authors.lastname: Navid
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Furman
authors.forename: Martin
authors.initials: M
authors.lastname: Fleming
authors.forename: Bhaskar N
authors.initials: BN
authors.lastname: Rao
authors.forename: Sandra
authors.initials: S
authors.lastname: Kovach
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Billups
authors.forename: Alvida M
authors.initials: AM
authors.lastname: Cain
authors.forename: Rex
authors.initials: R
authors.lastname: Amonette
authors.forename: Jesse J
authors.initials: JJ
authors.lastname: Jenkins
authors.forename: Alberto S
authors.initials: AS
authors.lastname: Pappo
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant; D002648:Child; D002675:Child, Preschool; D005240:Feasibility Studies; D006801:Humans; D007223:Infant; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects*; D008197:Lymph Node Excision; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D011994:Recombinant Proteins; D021701:Sentinel Lymph Node Biopsy; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D013534:Survival
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins