title: Melanoma Patient-Reported Quality of Life Outcomes Following Sentinel Lymph Node Biopsy, Completion Lymphadenectomy, and Adjuvant Interferon: Results from the Sunbelt Melanoma Trial.
abstract: BACKGROUND
  Quality of life (QOL) and physical condition (PC) outcomes after sentinel lymph node biopsy (SLNB), completion lymph node dissection (CLND), and adjuvant therapy with interferon alfa-2b (IFN) were evaluated in this study.
  
  
  METHODS
  Self-reported QOL and PC scores were evaluated in patients enrolled in a prospective, multicenter, randomized, clinical trial evaluating adjuvant IFN. After SLN biopsy, patients with a positive SLN underwent CLND then were randomized to adjuvant IFN or observation. QOL and PC scores were compared between patients who underwent SLNB alone, CLND without IFN, and CLND with IFN. Time to return to baseline QOL and PC scores reported at the time of SLNB was recorded and compared.
  
  
  RESULTS
  There were statistically significant differences in time to return to baseline QOL (p = 0.0018) and PC (p = 0.0018) scores across the three treatment groups. The time to return to baseline QOL and PC scores was similar for SLND and CLND alone. Differences in time to return to baseline QOL and PC were sustained when stratified by recurrence status but did not differ significantly for different lymph node regions. There was a delay in return to baseline QOL and PC condition scores that was sustained beyond the cessation of IFN therapy.
  
  
  CONCLUSIONS
  CLND is well-tolerated with a similar effect on self-reported QOL outcomes in both the short- and long-term compared with SLNB alone. IFN therapy is associated with worse QOL outcomes compared with SLNB and CLND, an effect that may be sustained following cessation of adjuvant IFN.
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Egger
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA.
authors.forename: Charles W
authors.initials: CW
authors.lastname: Kimbrough
authors.affiliation: Department of Statistics, University of Kentucky, Lexington, KY, USA.
authors.forename: Arnold J
authors.initials: AJ
authors.lastname: Stromberg
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA.
authors.forename: Amy R
authors.initials: AR
authors.lastname: Quillo
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA.
authors.forename: Robert C G
authors.initials: RC
authors.lastname: Martin
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA.
authors.forename: Charles R
authors.initials: CR
authors.lastname: Scoggins
authors.affiliation: The Hiram C. Polk, Jr, MD Department of Surgery, University of Louisville, Louisville, KY, USA. mcmasters@louisville.edu.
authors.forename: Kelly M
authors.initials: KM
authors.lastname: McMasters
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008197:Lymph Node Excision; D008198:Lymph Nodes; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D057566:Self Report; D021701:Sentinel Lymph Node Biopsy
chemical_list: D000276:Adjuvants, Immunologic; C554158:IFNA2 protein, human; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins