title: Adjuvant therapy of renal cell carcinoma patients with an autologous tumor cell lysate vaccine: a 5-year follow-up analysis.
abstract: BACKGROUND
  Non-metastasized renal cell carcinoma (RCC) is associated with postoperative progression in 1 out of 3 patients. However, no adjuvant therapy after radical nephrectomy has been established. We investigated the impact of an adjuvant autologous tumor cell lysate vaccination on the 5-year survival rates of patients with non-metastasized RCC.
  
  
  METHODS
  Between 1990 and 1995, a total of 360 patients with RCC underwent a radical nephrectomy at the St. Georg Hospital Leipzig, Germany. There were 236 patients with RCC stages T2N0M0 or T3N0M0. Out of this group, 148 consecutive patients received an adjuvant autologous tumor cell lysate vaccine (vaccine group, 72 patients with T2N0M0 and 76 patients with T3N0M0), while the remaining 88 patients had no adjuvant therapy (control group, 52 patients with T2N0M0 and 36 patients with T3N0M0). Both groups were comparable for parameters such as age, sex, tumor localization and size, and Störkel-score (p > 0.05 for each parameter; Chi-Square test and Wilcoxon-Mann-Whitney test).
  
  
  RESULTS
  For RCC stage T2N0M0, the 5-year progression-free survival rate in the control group was 65.3% compared to 84.6% in the vaccine group (p = 0.0023, log-rank test). The 5-year overall survival was 71.4% in the control group compared to 86% in the vaccine group (p = 0.0059, log-rank test). Patients with RCC stage T3N0M0 in the vaccine group demonstrated a clear advantage in terms of 5-year overall survival (77.5% vs. 25% in the control group, p < 0.0001, log-rank test) and 5-year progression-free survival (68.2% in the vaccine group vs. 19.4% in the control group, p < 0.0001, log-rank test).
  
  
  CONCLUSIONS
  Adjuvant autologous tumor cell lysate vaccination may improve the outcome of patients with non-metastasized RCC after radical nephrectomy. A prospective randomized and multicenter phase III trial was started in 1997 to confirm these results.
authors.affiliation: Department of Urology, St. Georg Hospital Leipzig, Delitzscher Str. 141, 04129 Leipzig, Germany. repi@surfEU.de
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Repmann
authors.forename: Andreas J W
authors.initials: AJ
authors.lastname: Goldschmidt
authors.forename: Axel
authors.initials: A
authors.lastname: Richter
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000276:immunology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000276:immunology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D019496:Cancer Vaccines