title: Adjuvant immunotherapy treatment of renal carcinoma patients with autologous tumor cells and bacillus Calmette-Guèrin: five-year results of a prospective randomized study.
abstract: BACKGROUND
  Active specific immunotherapy (ASI) is a strategy that attempts to boost the host's immune response specifically against its own tumor. The purpose of this study was to investigate the effect of adjuvant ASI in patients with renal carcinoma.
  
  
  METHODS
  Of 120 consecutive patients, 60 were randomized to a control group and 60 to receive ASI comprised of 3 intradermal injections of 10(7) autologous irradiated tumor cells mixed with 10(7) Bacillus Calmette-Guèrin (in the first 2 vaccinations) or alone. At randomization and 1, 6, and 12 months after completing immunotherapy, the treated patients were evaluated for the development of delayed type cutaneous hypersensitivity (DTCH) response to autologous tumor and autologous normal renal cells.
  
  
  RESULTS
  The baseline DTCH responses were negative in all patients. One month after completing ASI, 38 of 54 immunized patients showed a significant (P<0.01) DTCH response to autologous tumor but not to autologous normal renal cells. The response was persistent at 6 months in 25 of 44 patients and at 12 months in 16 of 28 patients. DTCH response remained negative in the nonimmunized control patients. There was no systemic toxicity but local ulcerations that healed in 2 months were observed. After a median follow-up of 61 months, the probability of 5-year disease free survival (DFS) was 63% for treated patients and 72% for control patients. The corresponding probability of 5-year overall survival (OS) was 69% and 78%, respectively. These differences were not statistically significant.
  
  
  CONCLUSIONS
  This is the first prospective randomized study of ASI in a large population of patients with renal carcinoma after radical nephrectomy. Our data clearly indicate that ASI can increase the reactivity to autologous tumor, as measured by the DTCH test, but it appears unable to affect DFS and OS of patients.
authors.affiliation: Centro di Riferimento Oncologico, Aviano, Italy.Gruppo Oncologico Clinico Cooperativo del Nord-Est.
authors.forename: E
authors.initials: E
authors.lastname: Galligioni
authors.forename: M
authors.initials: M
authors.lastname: Quaia
authors.forename: A
authors.initials: A
authors.lastname: Merlo
authors.forename: A
authors.initials: A
authors.lastname: Carbone
authors.forename: A
authors.initials: A
authors.lastname: Spada
authors.forename: D
authors.initials: D
authors.lastname: Favaro
authors.forename: M
authors.initials: M
authors.lastname: Santarosa
authors.forename: C
authors.initials: C
authors.lastname: Sacco
authors.forename: R
authors.initials: R
authors.lastname: Talamini
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000276:immunology / Q000628:therapy*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006968:Hypersensitivity, Delayed / Q000276:immunology; D007167:Immunotherapy; D007680:Kidney Neoplasms / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine