Es gibt eine Zubereitung dendritischer Zellen, die zur Behandlung des Prostatakarzinoms in den USA und Europa zugelassen war:
Provenge (bzw. Sipuleucel-T)
Die Zulassung in den USA besteht weiter; in Europa wurde diese jedoch auf Antrag des Herstellers (Dendreon) wiederrufen (siehe Information der EMA zu Provenge).
Sanpower Group Agrees to Acquire Dendreon From Valeant for $819.9 Million
Prostate Cancer InfoLink: Another new owner for Provenge (17-01-2017)
Sipuleucel-T Shows Potential With New Trial Data, But Questions Regarding Clinical Relevance Remain
Dendreon hat eine randomisierte kontrollierte Phase-III-Studie zum Einsatz von Provenge bei Patienten unter Active-Surveillance gestartet; die ProVent-Studie (NCT03686683).
Bis Mitte/Ende 2018 lief in Europa die Patientenrekrutierung der so genannten VIABLE-Studie:
Sponsor war/ist die Firma SOTIO aus der Tschechischen Republik.
SOTIO a.s.
Jankovcova 1518/2
Prague 7
170 00
Czech Republic
Literatur:
- Bilusic M, Madan RA, Gulley JL. Immunotherapy of Prostate Cancer: Facts and Hopes. Clin Cancer Res. 2017 Nov 15;23(22):6764-6770. doi: 10.1158/1078-0432.CCR-17-0019. (PMC Volltext)
- Beer TM, Vogelzang N, Bartůňková J, et al. Autologous dendritic cell immunotherapy (DCVAC/PCa) added to docetaxel chemotherapy in a Phase III trial (viable) in men with advanced (mCRPC) prostate cancer. J Immunother Cancer. 2015; 3(Suppl 2): P164. (Beschreibung des Protokolls der VIABLE-Studie.)
- Podrazil M, Horvath R, Becht E, et al. Phase I/II clinical trial of dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy in patients with metastatic, castration-resistant prostate cancer. Oncotarget. 2015 Jul 20;6(20):18192-205. (PMC Volltext):
We conducted an open-label, single-arm Phase I/II clinical trial in metastatic CRPC (mCRPC) patients eligible for docetaxel combined with treatment with autologous mature dendritic cells (DCs) pulsed with killed LNCaP prostate cancer cells (DCVAC/PCa). The primary and secondary endpoints were safety and immune responses, respectively. Overall survival (OS), followed as a part of the safety evaluation, was compared to the predicted OS according to the Halabi and MSKCC nomograms.
Conclusions
In patients with mCRPC, the combined chemoimmunotherapy with DCVAC/PCa and docetaxel was safe and resulted in longer than expected survival. Concomitant chemotherapy did not preclude the induction of specific anti-tumor cytotoxic T cells.