title: Is primary melanoma ulceration a factor of good response to adoptive immunotherapy?
abstract: BACKGROUND
  Primary melanoma ulceration is a factor of poor prognosis at the local and regional stage. The physiopathological mechanisms which explain its prognostic impact are still little known. However, two recent studies suggest that it could be a predictive factor of good response to a non-specific immunotherapy (interferon-alpha) and to an active immunotherapy (vaccine).
  
  
  OBJECTIVE
  The aim of this study was to determine whether ulceration could be a factor of good prognosis in the context of an adoptive immunotherapy with tumour infiltrating lymphocytes (TIL) in stage III regional lymph node metastatic melanoma (sixth American Joint Committee on Cancer staging system) and whether it was associated with an improvement in the effectiveness of this treatment compared with the control group.
  
  
  METHODS
  We have included all the patients treated in open prospective randomized TIL vs. control protocols in our unit from 1997 to 2009. Clinical data were derived retrospectively from patient files. Statistical analysis was performed using log-rank tests, Cox models and tests for interaction.
  
  
  RESULTS
  A total of 144 patients were included. In the group of 80 patients treated with TIL, primary melanoma ulceration remained a pejorative factor for relapse-free and overall survival in univariate and multivariate analysis. The presence of ulceration did not change the effectiveness of TIL treatment in comparison with the control group with regards to relapse-free and overall survival.
  
  
  CONCLUSIONS
  Our study demonstrates that primary melanoma ulceration does not have any impact on the response to TIL adoptive immunotherapy and thus does not confirm its positive prognostic value suggested by two other immunotherapy approaches.
authors.affiliation: Nantes University Hospital Centre, Skin Cancer Unit, Alexis Ricordeau             CIC biothérapie, INSERM 0305, Nantes, France.
authors.forename: L
authors.initials: L
authors.lastname: Peuvrel
authors.forename: J M
authors.initials: JM
authors.lastname: Nguyen
authors.forename: A
authors.initials: A
authors.lastname: Khammari
authors.forename: G
authors.initials: G
authors.lastname: Quereux
authors.forename: A
authors.initials: A
authors.lastname: Brocard
authors.forename: B
authors.initials: B
authors.lastname: Dreno
mesh_terms: D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016219:Immunotherapy, Adoptive; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D011379:Prognosis; D012189:Retrospective Studies; D012883:Skin Ulcer / Q000473:pathology*