title: Phase II pilot study of intravenous high-dose interferon with or without maintenance treatment in melanoma at high risk of recurrence.
abstract: OBJECTIVE
  High-dose interferon alfa-2b (HDI) has emerged as a potentially effective adjuvant therapy in patients with resected melanoma at high risk of recurrence. Evidence suggests it may be the early, very-high-dose part of the regimen that is critical. This pilot study sought to provide an early indication of whether the same effects can be achieved with the intravenous component of HDI alone and inform the feasibility and design of a phase III trial.
  
  
  METHODS
  Patients with stage 2B, 2C, 3B, and 3C melanoma were randomly assigned to receive interferon alfa-2b (IFN-α-2b) 20 MIU/m(2) intravenously (IV) daily 5 days per week for 4 weeks (arm A) versus the same regimen followed by IFN-α-2b 10 MIU/m(2) administered subcutaneously three times per week for 48 weeks (arm B) and observed for relapse-free survival (RFS) and overall survival.
  
  
  RESULTS
  Between 2003 and 2009, 194 patients were enrolled (arm A, 96; arm B, 98). After median follow-up of 39.5 months, RFS was 22.7 months (95% CI, 14.1 to 38.1 months) in arm A versus 33.3 months (95% CI, 18.2 to not reached) in arm B (P = .28). The proportions of patients free of relapse at 2 years were 50% and 54.1% (P = .569; hazard ratio, 0.89), respectively. Overall survival favored arm B (median, 41.5 months v not reached; P = .05).
  
  
  CONCLUSIONS
  Clinical outcomes were better in patients who had the longer regimen. Our results do not support either the use of a month of IV HDI alone in place of the year-long regimen or the initiation of a larger trial on this question.
authors.affiliation: Miranda J. Payne, Katerina Argyropoulou, Cheng Han, Sandie Wellman, and Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals National Health Service Trust, Oxford; Paul Lorigan, Christie Hospital, Manchester; James J. McAleer, Cancer Centre, Belfast City Hospital, Belfast, Northern Ireland; David Farrugia, Cheltenham Hospital, Cheltenham; Neville Davidson, Chelmsford Hospital, Chelmsford; Charles Kelly, Newcastle General Hospital, Newcastle upon Tyne; David Chao, Royal Free Hospital, Hampstead; and Ernest Marshall, Clatterbridge Centre for Oncology, Bebington, Wirral, United Kingdom.
authors.forename: Miranda J
authors.initials: MJ
authors.lastname: Payne
authors.forename: Katerina
authors.initials: K
authors.lastname: Argyropoulou
authors.forename: Paul
authors.initials: P
authors.lastname: Lorigan
authors.forename: James J
authors.initials: JJ
authors.lastname: McAleer
authors.forename: David
authors.initials: D
authors.lastname: Farrugia
authors.forename: Neville
authors.initials: N
authors.lastname: Davidson
authors.forename: Charles
authors.initials: C
authors.lastname: Kelly
authors.forename: David
authors.initials: D
authors.lastname: Chao
authors.forename: Ernest
authors.initials: E
authors.lastname: Marshall
authors.forename: Cheng
authors.initials: C
authors.lastname: Han
authors.forename: Sandie
authors.initials: S
authors.lastname: Wellman
authors.forename: Mark R
authors.initials: MR
authors.lastname: Middleton
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007372:Interferons / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000517:prevention & control*; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D055502:Secondary Prevention; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007372:Interferons