Progression-free And Overall Survival Are Prolonged Following An Adjuvant Vaccination With Reniale In Patients With Non-metastatic Renal Cell Carcino

Dr. Doehn, University of Lubeck Medical School reported on a Phase III trial of Reniale in renal cell carcinoma (RCCA). Five-year survival of patients with RCC is currently 63%. Therefore, adjuvant therapy of organ-confined RCC following operative therapy is proposed to reduce the risk of recurrence. Recently, Dr. Doehn's group has demonstrated in a randomized phase-III trial that an adjuvant renal tumor cell vaccine (Reniale) is effective in reducing the risk of tumor progression in patients with RCC following radical nephrectomy. At the URS meeting, they presented the results of a secondary analysis of this trial.

Between January 1997 and September 1998, 558 patients with a renal mass scheduled for radical nephrectomy were enrolled at 55 institutions in Germany. Before surgery all patients were centrally randomized to receive Reniale (6 intradermal applications at 4-week intervals postoperatively, Reniale group) or no adjuvant therapy (control group). Primary end point of the trial was to reduce the risk of tumor progression. Secondary major end points were overall survival and quality of life. Overall survival data were collected for the time period of January 1997 to July 2005. The trial was performed according to ICH-GCP guidelines.

The secondary intention-to-treat analysis was performed on 477 patients (233 patients in the Reniale group and 244 patients in the control group). Progression-free survival remained in favor of the Reniale group (p = 0.0476, log-rank test). Overall survival was not statistically significant different between both groups (p = 0.1185, log-rank test). Also, a secondary analysis of the per-protocol population was performed. There were 134 patients in the Reniale group and 218 patients in the control group. Both survival end points were statistically significant in favor of the Reniale group (p = 0.024, log-rank test, for progression-free survival and p = 0.0356, log-rank test, for overall survival, respectively). There was no serious vaccine-related adverse event. In general the vaccine was tolerated well.

This is the first published randomized phase-III trial that demonstrates a progression-free and overall survival benefit from an adjuvant therapy in patients with RCC after radical nephrectomy.

Urological Research Society Meeting, Salzburg Austria, September 7-10, 2006

By Christopher P. Evans, M.D.

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