title: Skin tests predict survival after autologous tumor cell vaccination in metastatic melanoma: experience in 81 patients.
abstract: BACKGROUND
  Currently there is no standard adjuvant treatment following surgical resection of metastatic melanoma. We investigated whether surgery followed by autologous tumor cell-BCG vaccination was beneficial for malignant melanoma patients. In this study we focus on the prognostic value of DTH response following vaccination therapy.
  
  
  METHODS
  Eighty-one patients with AJCC stage III and IV melanoma were selected. Whenever feasible, radical metastasectomy was performed. ASI was initiated by the administration of three weekly intra-cutaneous vaccinations with 10(7) irradiated autologous tumor cells, starting four weeks after surgery. Depending on the size of DTH response to the first three injections, subsequent vaccinations were planned. The first two vaccines also contained 10(7) BCG organisms as an immune stimulatory adjuvant.
  
  
  RESULTS
  Induration as well as erythema correlated strongly with survival (P < 0.0001 and P = 0.0004). After radical metastasectomy in stage III melanoma patients a five-year survival of 48% was observed. In stage IV disease, a five-year survival of 34% was seen, after radical surgery had been performed. When macroscopic disease was present at start of vaccination treatment, no clinical responses occurred. Apart from transient skin ulceration at the site of BCG-containing vaccinations, no serious side effects were observed.
  
  
  CONCLUSIONS
  This study shows that large-scale preparation of autologous melanoma cell vaccines is feasible. while vaccination results in DTH responses that correlate significantly with survival. ASI seemed to be beneficial in stage III and stage IV melanoma when given in the adjuvant setting, while causing only very mild side effects.
authors.affiliation: Department of Medical Oncology, University Hospital Vrije Universiteit, Amsterdam, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Baars
authors.forename: A M
authors.initials: AM
authors.lastname: Claessen
authors.forename: A J
authors.initials: AJ
authors.lastname: van den Eertwegh
authors.forename: H E
authors.initials: HE
authors.lastname: Gall
authors.forename: A G
authors.initials: AG
authors.lastname: Stam
authors.forename: S
authors.initials: S
authors.lastname: Meijer
authors.forename: G
authors.initials: G
authors.lastname: Giaccone
authors.forename: C J
authors.initials: CJ
authors.lastname: Meijer
authors.forename: R J
authors.initials: RJ
authors.lastname: Scheper
authors.forename: J
authors.initials: J
authors.lastname: Wagstaff
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: H M
authors.initials: HM
authors.lastname: Pinedo
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage / Q000276:immunology; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006968:Hypersensitivity, Delayed; D007279:Injections, Subcutaneous; D008297:Male; D008545:Melanoma / Q000276:immunology* / Q000628:therapy; D008875:Middle Aged; D011237:Predictive Value of Tests; D012878:Skin Neoplasms / Q000276:immunology* / Q000628:therapy; D012882:Skin Tests; D012883:Skin Ulcer / Q000209:etiology
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D019496:Cancer Vaccines