title: Randomized trial of vitamin A versus observation as adjuvant therapy in high-risk primary malignant melanoma: a Southwest Oncology Group study.
abstract: OBJECTIVE
  A national cooperative group trial was conducted in patients with early-stage cutaneous malignant melanoma to determine if oral vitamin A can increase disease-free survival or survival.
  
  
  METHODS
  Two hundred forty-eight patients with completely resected melanoma of Breslow's thickness greater than 0.75 mm and clinically negative lymph nodes were randomized to oral vitamin A (100,000 IU/d) for 18 months or to observation. Patients were stratified by Breslow's thickness of primary lesion (0.76 to 1.50 mm, 1.51 to 3.00 mm, or > 3.00 mm), sex, and type of therapy (excision, excision plus node dissection, excision plus perfusion, or excision plus both). The median duration of follow-up observation of living patients is greater than 8 years. The relative risk (RR) in disease-free survival and overall survival in the treatment compared with the observation group was calculated using Cox proportional hazards models.
  
  
  RESULTS
  Overall, there was no difference in disease-free survival or overall survival between the two groups. Examination of treatment by stratification interactions and subset analysis did not show any treatment-effect differences based on sex or type of therapy. There was also no difference between groups in disease-free survival based on Breslow's thickness of the primary lesion. Overall, 12% of patients who received vitamin A experienced grade 3 or 4 toxicities.
  
  
  CONCLUSIONS
  Based on the lack of overall survival benefit, further evaluation of vitamin A as adjuvant therapy for melanoma does not appear warranted.
authors.affiliation: University of California, Irvine, Orange.
authors.forename: F L
authors.initials: FL
authors.lastname: Meyskens
authors.forename: P Y
authors.initials: PY
authors.lastname: Liu
authors.forename: R J
authors.initials: RJ
authors.lastname: Tuthill
authors.forename: V K
authors.initials: VK
authors.lastname: Sondak
authors.forename: W S
authors.initials: WS
authors.lastname: Fletcher
authors.forename: W R
authors.initials: WR
authors.lastname: Jewell
authors.forename: W
authors.initials: W
authors.lastname: Samlowski
authors.forename: S P
authors.initials: SP
authors.lastname: Balcerzak
authors.forename: D J
authors.initials: DJ
authors.lastname: Rector
authors.forename: R D
authors.initials: RD
authors.lastname: Noyes
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D008875:Middle Aged; D016016:Proportional Hazards Models; D012307:Risk Factors; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D015996:Survival Rate; D014481:United States; D014801:Vitamin A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014801:Vitamin A