Burger, Maximilian and Thiounn, Nicolas and Denzinger, Stefan and Kondas, Jozsef and Benoit, Gerard and Chapado, Manuel S. and Jimenz-Cruz, Fernando J. and Kisbenedek, Laszlo and Szabo, Zoltan and Zsolt, Domjan and Grimm, Marc O. and Romics, Imre and Thueroff, Joachim W. and Kiss, Tamas and Tombal, Bertrand and Wirth, Manfred and Munsell, Marc and Mills, Bonnie and Koh, Tung and Sherman, Jeff (2010) The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial. JOURNAL OF TRANSLATIONAL MEDICINE, 8: 54. ISSN 1479-5876,
Full text not available from this repository. (Request a copy)Abstract
Introduction: While adjuvant immunotherapy with Bacille Calmette Guerin (BCG) is effective in non-muscle-invasive bladder cancer (BC), adverse events (AEs) are considerable. Monocyte-derived activated killer cells (MAK) are discussed as essential in antitumoural immunoresponse, but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy (BEXIDEM (R)) to BCG in patients after transurethral resection (TURB) of BC. Materials and methods: This open-label trial included 137 eligible patients with TaG1-3, T1G1-2 plurifocal or unifocal tumours and >= 2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation (BEXIDEM). Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile (primary endpoint) and prophylactic effects (secondary endpoint) were assessed. Results: Patient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM, 85% vs. 45% experienced AEs and 26% vs. 14% serious AEs (SAE), respectively (p < 0.001). Recurrence occurred significantly less frequent with BCG than with BEXIDEM (12% vs. 38%; p < 0.001). Discussion: This initial report of autologous intravesical macrophage cell therapy in BC demonstrates BEXIDEM treatment to be safe. Recurrence rates were significantly lower with BCG however. As the efficacy of BEXIDEM remains uncertain, further data, e. g. marker lesions studies, are warranted.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BACILLUS-CALMETTE-GUERIN; ACTIVATED KILLER-CELLS; DENDRITIC CELLS; ADOPTIVE IMMUNOTHERAPY; UROTHELIAL CARCINOMA; PROPHYLAXIS; PROGRESSION; INTERFERON; RECURRENCE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Urologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 28 Jul 2020 07:04 |
| Last Modified: | 28 Jul 2020 07:04 |
| URI: | https://pred.uni-regensburg.de/id/eprint/24567 |
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