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Nierenkrebs Therapie mit Reniale
27. Deutscher Krebskongress
Deutsche Krebsgesellschaft e.V.
22. bis 26.03.2006, Berlin
Meeting Abstract
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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