PMID- 20529333
OWN - NLM
STAT- MEDLINE
DCOM- 20100803
LR  - 20211020
IS  - 1479-5876 (Electronic)
IS  - 1479-5876 (Linking)
VI  - 8
DP  - 2010 Jun 8
TI  - The application of adjuvant autologous antravesical macrophage cell therapy vs. 
      BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial.
PG  - 54
LID - 10.1186/1479-5876-8-54 [doi]
AB  - 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) 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.
FAU - Burger, Maximilian
AU  - Burger M
AD  - Department of Urology, Caritas St, Josef Medical Centre, University of 
      Regensburg, Regensburg, Germany. maximilian.burger@klinik.uni-regensburg.de
FAU - Thiounn, Nicolas
AU  - Thiounn N
FAU - Denzinger, Stefan
AU  - Denzinger S
FAU - Kondas, Jozsef
AU  - Kondas J
FAU - Benoit, Gerard
AU  - Benoit G
FAU - Chapado, Manuel S
AU  - Chapado MS
FAU - Jimenz-Cruz, Fernando J
AU  - Jimenz-Cruz FJ
FAU - Kisbenedek, Laszlo
AU  - Kisbenedek L
FAU - Szabo, Zoltan
AU  - Szabo Z
FAU - Zsolt, Domjan
AU  - Zsolt D
FAU - Grimm, Marc O
AU  - Grimm MO
FAU - Romics, Imre
AU  - Romics I
FAU - Thuroff, Joachim W
AU  - Thuroff JW
FAU - Kiss, Tamas
AU  - Kiss T
FAU - Tombal, Bertrand
AU  - Tombal B
FAU - Wirth, Manfred
AU  - Wirth M
FAU - Munsell, Marc
AU  - Munsell M
FAU - Mills, Bonnie
AU  - Mills B
FAU - Koh, Tung
AU  - Koh T
FAU - Sherman, Jeff
AU  - Sherman J
LA  - eng
SI  - ISRCTN/ISRCTN35881130
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20100608
PL  - England
TA  - J Transl Med
JT  - Journal of translational medicine
JID - 101190741
RN  - 0 (Adjuvants, Immunologic)
SB  - IM
MH  - Adjuvants, Immunologic/adverse effects/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Demography
MH  - Female
MH  - Humans
MH  - Immunotherapy/adverse effects
MH  - Macrophages/*transplantation
MH  - Male
MH  - Middle Aged
MH  - Muscles/pathology
MH  - Mycobacterium bovis/*immunology
MH  - Neoplasm Invasiveness
MH  - Urinary Bladder Neoplasms/microbiology/*pathology/*therapy
PMC - PMC2893125
EDAT- 2010/06/10 06:00
MHDA- 2010/08/04 06:00
PMCR- 2010/06/08
CRDT- 2010/06/10 06:00
PHST- 2010/03/16 00:00 [received]
PHST- 2010/06/08 00:00 [accepted]
PHST- 2010/06/10 06:00 [entrez]
PHST- 2010/06/10 06:00 [pubmed]
PHST- 2010/08/04 06:00 [medline]
PHST- 2010/06/08 00:00 [pmc-release]
AID - 1479-5876-8-54 [pii]
AID - 10.1186/1479-5876-8-54 [doi]
PST - epublish
SO  - J Transl Med. 2010 Jun 8;8:54. doi: 10.1186/1479-5876-8-54.