title: Role functioning before start of adjuvant treatment was an independent prognostic factor for survival and time to failure. A report from the Nordic adjuvant interferon trial for patients with high-risk melanoma.
abstract: OBJECTIVE
  To investigate the role of health-related quality of life (HRQoL) at randomization as independent prognostic factors for survival and time to failure, and to explore associations between HRQoL and treatment effects.
  
  
  METHODS
  In the Nordic adjuvant interferon trial, a randomized trial evaluating if adjuvant therapy with intermediate-dose IFN had the same beneficial effects on overall and disease-free survival in high-risk melanoma as high-dose IFN, 855 patients in Denmark, Finland, Norway, and Sweden were included. The EORTC QLQ-C30 questionnaire was used to assess HRQoL before randomization.
  
  
  RESULTS
  A total of 785 (92%) agreed to participate in the HRQoL-study and provided baseline HRQoL data. Prognostic variables included in the multivariate model were age, sex, performance status, tumor thickness, stage, and number of positive lymph nodes. Univariate analyses revealed an association between prolonged survival and age, stage/ number of metastatic lymph nodes and the HRQoL variable role functioning (p ≤ 0.01). After controlling for other prognostic factors, these variables remained independently statistically significant for survival. The univariate analyses of time to failure showed significant associations with the clinical variable stage/nodes and with the HRQoL variables physical functioning and role functioning. Adjusted multivariate analyses including the same clinical conditions as above showed statistically significant relationships between time to failure and global quality of life, physical functioning, role functioning, social functioning and fatigue (p ≤ 0.01). No interactions between HRQoL variables and treatment were found, with the exception for cognitive functioning.
  
  
  CONCLUSIONS
  Role functioning was found to be an independent prognostic factor for time to failure and survival in patients with high-risk melanoma. Thus, also in this early stage of melanoma, HRQoL variables might be useful as important prognostic factors for time to failure and overall survival.
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Brandberg
authors.forename: Hemming
authors.initials: H
authors.lastname: Johansson
authors.forename: Steinar
authors.initials: S
authors.lastname: Aamdal
authors.forename: Lars
authors.initials: L
authors.lastname: Bastholt
authors.forename: Michaela
authors.initials: M
authors.lastname: Hernberg
authors.forename: Ulrika
authors.initials: U
authors.lastname: Stierner
authors.forename: Hans
authors.initials: H
authors.lastname: von der Maase
authors.forename: Johan
authors.initials: J
authors.lastname: Hansson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007372:Interferons / Q000008:administration & dosage*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D007372:Interferons