Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 Jun 8:8:54.
doi: 10.1186/1479-5876-8-54.

The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial

Maximilian Burger  1 , Nicolas Thiounn, Stefan Denzinger, Jozsef Kondas, Gerard Benoit, Manuel S Chapado, Fernando J Jimenz-Cruz, Laszlo Kisbenedek, Zoltán Szabo, Domján Zsolt, Marc O Grimm, Imre Romics, Joachim W Thüroff, Tamas Kiss, Bertrand Tombal, Manfred Wirth, Marc Munsell, Bonnie Mills, Tung Koh, Jeff Sherman
Affiliations
Randomized Controlled Trial

The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial

Maximilian Burger et al. J Transl Med. .

Abstract

Introduction: While adjuvant immunotherapy with Bacille Calmette Guérin (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) 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 >or=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.

Trial registration: The trial has been registered in the ISRCTN registry http://isrctn.org under the registration number ISRCTN35881130.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Scheme of BEXIDEM preparation and administration.
See this image and copyright information in PMC

References

    1. Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Böhle A, Palou-Redorta J. EAU Guidelines on Non-Muscle-Invasive Urothelial Carcinoma of the Bladder. Eur Urol. 2008;54(2):303–14. doi: 10.1016/j.eururo.2008.04.051. - DOI - PubMed
    1. Witjes JA, Hendricksen K. Intravesical pharmacotherapy for non-muscle-invasive bladder cancer: a critical analysis of currently available drugs, treatment schedules, and long-term results. Eur Urol. 2008;53(1):45–52. doi: 10.1016/j.eururo.2007.08.015. - DOI - PubMed
    1. Herr HW, Morales A. History of bacillus Calmette-Guerin and bladder cancer: an immunotherapy success story. J Urol. 2008;179(1):53–6. doi: 10.1016/j.juro.2007.08.122. - DOI - PubMed
    1. Ojea A, Nogueira JL, Solsona E, Flores N, Gómez JM, Molina JR, Chantada V, Camacho JE, Piñeiro LM, Rodríguez RH, Isorna S, Blas M, Martínez-Piñeiro JA, Madero R. CUETO Group (Club Urológico Español De Tratamiento Oncológico) A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C. Eur Urol. 2007;52(5):1398–406. doi: 10.1016/j.eururo.2007.04.062. - DOI - PubMed
    1. Fernandez-Gomez J, Solsona E, Unda M, Martinez-Piñeiro L, Gonzalez M, Hernandez R, Madero R, Ojea A, Pertusa C, Rodriguez-Molina J, Camacho JE, Isorna S, Rabadan M, Astobieta A, Montesinos M, Muntañola P, Gimeno A, Blas M, Martinez-Piñeiro JA. Club Urológico Español de Tratamiento Oncológico (CUETO) Prognostic factors in patients with non-muscle-invasive bladder cancer treated with bacillus Calmette-Guérin: multivariate analysis of data from four randomized CUETO trials. Eur Urol. 2008;53(5):992–1001. doi: 10.1016/j.eururo.2007.10.006. - DOI - PubMed

Publication types

Substances

Associated data