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Achtung: das Unternehmen LipoNova AG hat im Sommer 2008 Insolvenz angemeldet und existiert nicht mehr. Daher wird sich die Entwicklung einer vermarktungsfähigen Version von Reniale auf unbestimmte Zeit verzögern. Die Insolvenz hatte dem Vernehmen nach rein wirtschaftliche und regulatorische Gründe, die keinen unmittelbaren Bezug zum sich abzeichnenden  therapeutischen Wert der autologen Tumorvakzine hatten. Die werbenden Hinweise auf Reniale  haben daher keinerlei wirtschaftliche, sondern ausschließlich medizinisch wissenschaftliche Gründe und dokumentieren die regulatorischen Hürden mit denen kleine finanzschwache  Unternehmen zu kämpfen haben.

 

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        Anticancer Res. 2003 Mar-Apr;23(2A):969-74.

Adjuvant therapy of renal cell carcinoma patients with an autologous tumor cell lysate vaccine: a 5-year follow-up analysis.

Department of Urology, St. Georg Hospital Leipzig, Delitzscher Str. 141, 04129 Leipzig, Germany. repi@surfEU.de

BACKGROUND: 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 non-metastasized RCC.

PATIENTS 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).

RESULTS: 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).

CONCLUSION: 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.

PMID: 12820332 [PubMed - indexed for MEDLINE] Link

 

        Folia Biol (Praha). 2003;49(2):69-73. Links

 

Adjuvant autologous 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.

Department of Urology, University of Lübeck Medical School, Lübeck, Germany. doehn@medinf.mu-luebeck.de

Even 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 guidelines.

The 3-year progression-free survival rate for all tumour stages was 84.7% in the vaccine group and 80.9% in the control group.

 Patients 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.

PMID: 12779015 [PubMed - indexed for MEDLINE] Link

 

Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal-cell carcinoma after radical nephrectomy: phase III, randomised controlled trial.

Department of Urology, University of Lübeck Medical School, Ratzeburger Allee 160, 23538 Lübeck, Germany. Prof.Jocham.MUL@t-online.de

BACKGROUND: 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.

METHODS: 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.  

FINDINGS: 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 the treatment.

INTERPRETATION: 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.

PMID: 14987883 [PubMed - indexed for MEDLINE] Link

 



 

 

 

 

 

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