title: Enrollment in clinical trials correlates with improved survival in metastatic melanoma.
abstract: BACKGROUND
  Although the current median survival time of stage-IV melanoma patients is less than 12 months, there is a subset of patients who experience long-term survival. Due to poor response rates to standard cytotoxic agents in metastatic melanoma, patients are encouraged to participate in clinical trials, the overall impact of which has not been studied, however. The aim of our study was to identify the factors associated with long-term survival and to determine the impact of clinical trial enrollment on patient outcome.
  
  
  METHODS
  We studied stage-IV melanoma patients prospectively enrolled at New York University Medical Center from 2002-2008. Associations between clinicopathologic variables and overall post-stage-IV survival were examined. Kaplan-Meier survival analysis was used to identify univariate predictors of post-stage-IV survival and the independent effect of these variables was assessed in a multivariate Cox proportional hazards regression model. The associations between clinicopathologic variables and long-term survival status (≥2 vs. <2 years) were examined by χ(2) analysis and the independent effect of these variables on the latter was assessed in a multivariate logistic regression model.
  
  
  RESULTS
  Site of metastasis, treatment (systemic vs. localized) and pretreatment lactate dehydrogenase (LDH) level independently correlated with post-stage-IV survival. Participation in clinical trials and normal LDH levels were associated with a long-term survival of ≥2 years.
  
  
  CONCLUSIONS
  Our data suggest that enrollment in clinical trials independently correlates with prolonged survival after a diagnosis of stage IV melanoma.
authors.affiliation: Department of Medicine, New York University School of Medicine, New York, NY, USA.
authors.forename: Nagashree
authors.initials: N
authors.lastname: Seetharamu
authors.forename: Ting J
authors.initials: TJ
authors.lastname: Tu
authors.forename: Paul
authors.initials: P
authors.lastname: Christos
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Ott
authors.forename: Russell S
authors.initials: RS
authors.lastname: Berman
authors.forename: Richard L
authors.initials: RL
authors.lastname: Shapiro
authors.forename: Iman
authors.initials: I
authors.lastname: Osman
authors.forename: Anna C
authors.initials: AC
authors.lastname: Pavlick
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging / Q000379:methods; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D013534:Survival; D016019:Survival Analysis