By Laura Gater
ANAHEIM, CA -- May 24, 2007 -- An adjuvant antilogous renal-cell tumour vaccination (Reniale) prolongs progression-free survival (PFS) in patients with renal-cell carcinoma (RCC), according to researchers presenting here at the American Urological Association (AUA) annual meeting.
Reniale is the first adjuvant therapy to show benefit to patients with RCC, according to lead investigator Christopher Doehn, MD, PhD, FEBU, department of urology, University of Lubeck Medical School, Lubeck, Germany.
A 1997-1998 Reniale trial compared radical nephrectomy plus Reniale versus radical nephrectomy alone in patients with primary RCC stage pT2-3bpN0-3MO. The 558 patients with a renal mass scheduled for radical nephrectomy at 55 institutions in Germany were enrolled in the trial, and were randomised to receive 6 intradermal applications of Reniale at 4-week intervals post-operatively (Reniale group) or no adjuvant therapy (control group).
The primary endpoint of the Reniale trial was to reduce the risk of tumour progression. Overall survival (OS) and quality of life were the main secondary endpoints.
The secondary analysis of this trial was performed on 477 patients (233 patients in the Reniale group and 244 in the control group), compared to 379 patients in the primary analysis. The secondary analysis redefined the per-protocol (PP) and intention-to-treat (ITT) groups and comprised a higher number of patients as compared to the primary trial analysis. OS and PFS data were calculated for both groups.
The PP population was defined as all randomised patients who fulfilled all inclusion criteria, did not deviate from any exclusion criteria, and had been in the study at least 6 months. Patients who were randomised to the Reniale group had to have received all 6 vaccinations (n = 352 patients), explained Dr. Doehn in a presentation on May 20th.
"Patients with a higher risk had higher benefit from an adjuvant therapy with Reniale," said Dr. Doehn.
Presently, a vaccination with Reniale is the only adjuvant therapy that improves PFS and OS in patients with RCC, following radical nephrectomy, noted Dr. Doehn. He stated that 30% of patients undergoing cytokine therapy and 10% - 20% of patients receiving TK1s will cease therapy due to side effects, so Reniale is an important potential treatment.
Only 1.7% of patients experienced side effects from Reniale, and no serious adverse events were reported from the vaccine.
[Presentation title: An Adjuvant Vaccination With Reniale Prolongs Survival in Patients With Renal Cell Carcinoma Following Radical Nephrectomy: Secondary Analysis of a Multicenter Phase-III Trial. Abstract 500]
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