Meeting
Abstract
27.
Deutscher Krebskongress
Deutsche Krebsgesellschaft e.V.
22. bis 26.03.2006, Berlin
Prolongation of progression-free and overall
survival following an adjuvant vaccination with Reniale® in
patients with non-metastatic renal cell carcinoma: Secondary
analysis of a multicenter phase-III trial
corresponding author presenting author
Christian Doehn - Universitätsklinikum Schleswig-Holstein (UKSH),
Campus Lübeck, Lübeck, Deutschland
author Axel Richter - Krankenhaus St.
Georg, Leipzig
author Rudolf A. Theodor - PHAROS GmbH,
Ulm
author Walter Lehmacher - Universität
zu Köln, Köln
author Dieter Jocham - Universitätsklinikum
Schleswig-Holstein (UKSH), Campus Lübeck, Lübeck
The electronic version of this article is the complete one and
can be found online at:
http://www.egms.de/en/meetings/dkk2006/06dkk395.shtml#Abstract
Published: 20-03-2006 © 2006 Doehn et al; licensee .
This is an Open Access article: verbatim
copying and redistribution of this article are permitted in
all media for any purpose, provided this notice is preserved
along with the article's
original URL.
Text
Introduction & Objectives: Recently,
we have demonstrated in a randomized phase-III trial that an
adjuvant vaccination with Reniale® reduces the risk of tumor
progression in patients with non-metastatic renal cell carcinoma
(RCC) [Lancet, 363(9409): 594-599, 2004]. We herein present
the results of a secondary analysis of this trial performed
in 2005 in response to questions raised by the European Agency
for the Evaluation of Medicinal Products (EMEA).
Material & Methods: Between January
1997 and August 1998, 558 patients with a renal mass scheduled
for radical nephrectomy were enrolled at 55 hospitals in Germany.
Prior to radical nephrectomy all patients were centrally randomized
to receive an adjuvant vaccination at 4-week intervals (Reniale®
group) or no adjuvant therapy (control group). Primary end point
of the trial was the reduction of the risk of tumor progression.
Secondary major end points were overall survival (OS) and quality
of life. OS data were collected for the time period of January
1997 to July 2005. The trial was performed according to ICH-GCP
guidelines.
Results: This secondary ITT analysis
was performed on 477 patients (233 patients in the Reniale
group and 244 patients in the control group). Progression-free
survival (PFS) remained in favor of the Reniale group
(p = 0.0476, log-rank test). OS was not statistically significant
different between both groups (p = 0.1185, log-rank test). Also,
a secondary analysis of the per-protocol (PP) population was
performed. There were 134 patients in the Reniale® group and
218 patients in the control group. Both end points (PFS and
OS) were statistically significant in favor of the Reniale group
(p = 0.024, log-rank test, for PFS and p = 0.0356, log-rank
test, for OS, respectively).
There was no serious vaccine-related adverse
event. In general the vaccine was tolerated well.
Conclusions: The primary end point,
i.e. reduction
of the risk of tumor progression, remained reached in this secondary
ITT analysis. Additionally, PFS and OS were prolonged in the
Reniale® group compared to the control group (PP analysis).
This is the first published randomized phase-III trial demonstrating
a benefit from an adjuvant therapy in patients with non-metastatic
RCC after radical nephrectomy.
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