Adjuvant therapy of renal cell carcinoma with active-specific-immunotherapy (ASI) using autologous tumor vaccine.

116 patients with renal cell carcinoma were treated with autologous tumor vaccine after radical nephrectomy. The survival rate of these patients compared to a historical control group of 106 patients from the same hospital, which received identical surgical treatment but no adjuvant therapy was evaluated. According to defined in- and exclusion criteria there was no statistical difference between the two groups. As a consequence any significant effects resulting from the treatment with autologous tumor vaccines have to be interpreted as clinically relevant in spite of the fact that no prospective randomised design was chosen. A clear significant difference (p = 0.0007) between both groups with a benefit for the group treated with autologous tumor vaccines was observed. According to the individual Robson stages patients in Robson II (p = 0.02) and Robson III (p = 0.04) showed significantly different survival rates. Due to the short follow-up time in the group Robson I and the limited number of patients in the group Robson IV no significant difference was observed. During adjuvant treatment with autologous tumor vaccine 2 patients out of 116 showed minor side effects not exceeding WHO-grade 1.

RCT Entities:   Population Interventions Outcomes