title: A randomised phase II trial of 1 month versus 1 year of adjuvant high-dose interferon α-2b in high-risk acral melanoma patients.
abstract: BACKGROUND
  High-dose Interferon-α-2b (HD-IFN) is an adjuvant treatment for melanoma. However, clinical trials for HD-IFN have not been reported in acral melanoma (AM), the predominant subtype of cutaneous melanoma in Asian population.
  
  
  METHODS
  Patients with resected high-risk (stage IIb-IIIc) AM were randomly assigned to a regimen of 4-week (arm A: 15 × 10(6)U/m(2)d1-5/w × 4w) or 1-year adjuvant HD-IFN (arm B: 15 × 10(6)U/m(2)d1-5/w × 4w+9 × 10(6)Utiw × 48w), respectively. The endpoints were relapse-free survival (RFS), overall survival (OS) and toxicities.
  
  
  RESULTS
  A total of 158 patients were enrolled in this study and 147 patients were eligible for survival analysis. With a median follow-up of 36.1 months, median RFS for arm A and arm B were 17.9 months and 22.5 months, respectively (P=0.72). Stratified analysis showed that RFS curves of patients in stage IIIb-IIIc were statistically different between arm A and arm B (P=0.02). The median RFS of patients with more nodal metastases (n⩾3) was shorter (P=0.004) in arm A (3.3 months) than that in arm B (11.9 months). Grade 1/2 adverse effects were observed in both groups. However, patients in arm B showed higher incidence of reversible Grade 3/4 hepatotoxicity (P=0.03).
  
  
  CONCLUSIONS
  The induction dose of 15 × 10(6)U/m(2) and the maintenance dose of 9 × 10(6)U were tolerable, which may be the optional dose intensity for adjuvant IFN-α-2b therapy in Chinese high risk AM population. No statistical significance was detected in RFS between the 4-week and 1-year regimen while a 1-year regimen may show clinical benefits in patients with stage IIIb-IIIc AM or with ≥ 3 nodal metastases.
authors.affiliation: Department of Melanoma and Renal Cancer, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China.
authors.forename: Lili
authors.initials: L
authors.lastname: Mao
authors.forename: Lu
authors.initials: L
authors.lastname: Si
authors.forename: Zhihong
authors.initials: Z
authors.lastname: Chi
authors.forename: Chuanliang
authors.initials: C
authors.lastname: Cui
authors.forename: Xinan
authors.initials: X
authors.lastname: Sheng
authors.forename: Siming
authors.initials: S
authors.lastname: Li
authors.forename: Bixia
authors.initials: B
authors.lastname: Tang
authors.forename: Jun
authors.initials: J
authors.lastname: Guo
mesh_terms: D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012008:Recurrence; D012306:Risk; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha