of renal cell carcinoma patients with an autologous tumor cell
lysate vaccine: a 5-year follow-up analysis.
of Urology, St. Georg Hospital Leipzig, Delitzscher Str. 141,
04129 Leipzig, Germany. repi@surfEU.de
Non-metastasized renal cell carcinoma (RCC) is associated with
postoperative progression in 1 out of 3 patients. However, no
adjuvant therapy after radical nephrectomy has been established.
We investigated the impact of an adjuvant autologous tumor cell
lysate vaccination on the 5-year survival rates of patients with
AND METHODS: Between 1990 and 1995, a total of 360 patients
with RCC underwent a radical nephrectomy at the St. Georg Hospital
Leipzig, Germany. There were 236 patients with RCC stages T2N0M0
or T3N0M0. Out of this group, 148 consecutive patients received
an adjuvant autologous tumor cell lysate vaccine (vaccine group,
72 patients with T2N0M0 and 76 patients with T3N0M0), while the
remaining 88 patients had no adjuvant therapy (control group,
52 patients with T2N0M0 and 36 patients with T3N0M0). Both groups
were comparable for parameters such as age, sex, tumor localization
and size, and Störkel-score (p > 0.05 for each parameter; Chi-Square
test and Wilcoxon-Mann-Whitney test).
For RCC stage T2N0M0, the 5-year progression-free survival rate
in the control group was 65.3% compared to 84.6% in the vaccine
group (p = 0.0023, log-rank test). The 5-year overall survival
was 71.4% in the control group compared to 86% in the vaccine
group (p = 0.0059, log-rank test). Patients with RCC stage T3N0M0
in the vaccine group demonstrated a clear advantage in terms of
5-year overall survival (77.5% vs. 25% in the control group, p
< 0.0001, log-rank test) and 5-year progression-free survival
(68.2% in the vaccine group vs. 19.4% in the control group, p
< 0.0001, log-rank test).
Adjuvant autologous tumor cell lysate vaccination may improve
the outcome of patients with non-metastasized RCC after
radical nephrectomy. A prospective randomized and multicenter
phase III trial was started in 1997 to confirm these results.
12820332 [PubMed - indexed for MEDLINE]
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.
of Urology, University of Lübeck Medical School, Lübeck, Germany.
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
3-year progression-free survival rate for all tumour stages was
84.7% in the vaccine group and 80.9% in the control group.
with RCC stage pT3pN0-3M0 in the vaccine group demonstrated an
advantage (74.4% in the vaccine group vs 65.9% in the control
group). For RCC stage pT2pN0-3M0 the 3-year progression-free survival
rate in the vaccine group was 89.7% compared to 85.7% in the control
group. Follow-up of all patients enrolled in this trial is ongoing.
This is the first randomized trial indicating a benefit from an
adjuvant vaccination in patients with M0 RCC after radical nephrectomy.
The advantage in terms of progression-free
survival was more pronounced in patients with T3-tumours.
However, it must be emphasized that the results of the final study
report (2003) must be awaited before definite recommendations
can be made.
12779015 [PubMed - indexed for MEDLINE]
renal tumour cell vaccine and risk of tumour progression in patients
with renal-cell carcinoma after radical nephrectomy: phase III,
randomised controlled trial.
of Urology, University of Lübeck Medical School, Ratzeburger Allee
160, 23538 Lübeck, Germany. Prof.Jocham.MUL@t-online.de
Organ-confined renal-cell carcinoma is associated with tumour
progression in up to 50% of patients after radical nephrectomy.
At present, no effective adjuvant treatment is established. We
aimed to investigate the effect of an autologous renal tumour
cell vaccine on risk of tumour progression in patients with stage
pT2-3b pN0-3 M0 renal-cell carcinoma.
Between January, 1997, and September, 1998, 558 patients with
a renal tumour scheduled for radical nephrectomy were enrolled
at 55 institutions in Germany. Before surgery, all patients were
centrally randomised to receive autologous renal tumour cell vaccine
(six intradermal applications at 4-week intervals postoperatively;
vaccine group) or no adjuvant treatment (control group). The primary
endpoint of the trial was to reduce the risk of tumour progression,
defined as progression or death. All patients were assessed after
standardised diagnostic investigations at 6-month intervals for
a minimum of 4.5 years.
By preoperative and postoperative inclusion criteria, 379
patients were assessable for the intention-to-treat analysis.
At 5-year and 70-month follow-up, the hazard ratios for tumour
progression were 1.58 (95% CI 1.05-2.37) and 1.59 (1.07-2.36),
respectively, in favour of the vaccine group (p=0.0204, log-rank
test). 5-year and 70-month progression-free survival rates were
77.4% and 72%, respectively, in the vaccine group and 67.8% and
59.3%, respectively, in the control group. The vaccine was well
tolerated, with only 12 adverse events associated with
Adjuvant treatment with autologous renal tumour cell vaccine in
patients with renal-cell carcinoma after radical nephrectomy
seems to be beneficial and can be considered in patients
undergoing radical nephrectomy due to organ-confined renal-cell
carcinoma of more than 2.5 cm in diameter.
14987883 [PubMed - indexed for MEDLINE]