Adjuvant Autologous Tumour Cell-Lysate Vaccine versus No Adjuvant Treatment in Patients with M0 Renal Cell Carcinoma after Radical Nephrectomy: 3-Year Interim Analysis of a German Multicentre Phase-III Trial

作者：C. Doehn, Axel Richter, Walter Lehmacher, D. Jocham · 发表于：Folia Biologica · 年份：2003 · DOI：10.14712/fb2003049020069 · 被引用次数：9 · 研究领域：Renal and related cancers、Renal cell carcinoma treatment、Cancer Immunotherapy and Biomarkers

Even M0 RCC is associated with tumour progression in approximately 30% of all patients after radical nephrectomy. Nevertheless, no effective adjuvant treatment after radical nephrectomy has been established. In a multicentre phase-III trial we investigated the impact of an adjuvant autologous tumour cell-lysate vaccination on the progression-free survival of patients with M0 RCC after radical nephrectomy. Between January 1997 and August 1998 a total of 558 patients with a renal tumour were enrolled at 55 different centres (study group) in Germany. Prior to radical nephrectomy all patients were centrally randomized (Quintiles Germany) to either receive an adjuvant autologous tumour cell-lysate vaccine (6 applications at 4-week intervals after radical nephrectomy) or to receive no adjuvant treatment (control group) after radical nephrectomy. All patients were evaluated following standardized diagnostic investigations at 6-month intervals. Following the inclusion criteria (RCC stages pT2-3bpN0-3M0, TNM-classification, UICC 1993), 365 patients were evaluable for the 3-year progression-free survival analysis. There were 240 patients with stage pT2pN0M0 (104 in the vaccine group and 136 patients in the control group) and 89 patients with stage pT3pN0M0 (46 in the vaccine group and 43 patients in the control group). The remaining 36 patients had positive lymph nodes. The trial was performed according to ICH-GCP guidelines. The 3-year progression-free survival rate for all tumour sta...