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Phase II Study of the Human Anti-Epithelial Cell Adhesion Molecule Antibody Adecatumumab in Prostate Cancer Patients with Increasing Serum Levels of Prostate-Specific Antigen after Radical Prostatectomy

Marschner, Norbert; Ruettinger, Dominik; Zugmaier, Gerhard; Nemere, Gyula; Lehmann, Jan; Obrist, Peter; Baeuerle, Patrick A.; Wolf, Andreas; Schmidt, Margit and Abrahamsson, Per-Anders LU , et al. (2010) In Urologia Internationalis 85(4). p.386-395
Abstract
Background: Rising serum levels of prostate-specific antigen (PSA) after radical prostatectomy are indicative of recurrent prostate cancer. This double-blind, placebo-controlled phase II study evaluated the anti-tumour activity of the anti-epithelial cell adhesion molecule (EpCAM) antibody adecatumumab in delaying biochemical disease progression. Patients and Methods: Prostate cancer patients with increasing serum PSA levels following radical prostatectomy were randomized to low- (2 mg/kg) or high-dose adecatumumab (6 mg/kg) or placebo. The primary efficacy endpoint was the mean change from baseline in total serum PSA at week 24. Secondary endpoints included PSA response rate, prolongation of serum PSA doubling time and time to biochemical... (More)
Background: Rising serum levels of prostate-specific antigen (PSA) after radical prostatectomy are indicative of recurrent prostate cancer. This double-blind, placebo-controlled phase II study evaluated the anti-tumour activity of the anti-epithelial cell adhesion molecule (EpCAM) antibody adecatumumab in delaying biochemical disease progression. Patients and Methods: Prostate cancer patients with increasing serum PSA levels following radical prostatectomy were randomized to low- (2 mg/kg) or high-dose adecatumumab (6 mg/kg) or placebo. The primary efficacy endpoint was the mean change from baseline in total serum PSA at week 24. Secondary endpoints included PSA response rate, prolongation of serum PSA doubling time and time to biochemical disease progression. Results: The primary and secondary endpoints of the study were not met in the predefined analyses. In a retrospective analysis of patients with baseline PSA <= 1 ng/ml and a high EpCAM expression, both the mean increase in PSA from baseline to week 24 and the PSA doubling time at week 15 were significantly improved in the high-dose adecatumumab group compared with the placebo group. Most frequent treatment-related clinical adverse events were gastrointestinal (diarrhoea and nausea) or general events (chills), showing a dose dependency but no grade 3/4 intensity in any patient. Conclusion: In men with rising PSA levels after radical prostatectomy and no evidence of clinical relapse, adecatumumab delayed disease progression in a subgroup of patients with baseline PSA levels <= 1 ng/ml and high EpCAM-expressing tumours. Copyright (C) 2010 S. Karger AG, Basel (Less)
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published
subject
keywords
Phase II study, Prostate-specific antigen, Prostate cancer, Human monoclonal antibody, MT201, Adecatumumab
in
Urologia Internationalis
volume
85
issue
4
pages
386 - 395
publisher
Karger
external identifiers
  • wos:000285582100003
  • scopus:78650991636
ISSN
0042-1138
DOI
10.1159/000318055
language
English
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yes
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7b2a18e6-970d-49a9-8853-599fd7a0fac5 (old id 1815136)
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2011-03-02 12:53:17
date last changed
2018-05-29 10:15:12
@article{7b2a18e6-970d-49a9-8853-599fd7a0fac5,
  abstract     = {Background: Rising serum levels of prostate-specific antigen (PSA) after radical prostatectomy are indicative of recurrent prostate cancer. This double-blind, placebo-controlled phase II study evaluated the anti-tumour activity of the anti-epithelial cell adhesion molecule (EpCAM) antibody adecatumumab in delaying biochemical disease progression. Patients and Methods: Prostate cancer patients with increasing serum PSA levels following radical prostatectomy were randomized to low- (2 mg/kg) or high-dose adecatumumab (6 mg/kg) or placebo. The primary efficacy endpoint was the mean change from baseline in total serum PSA at week 24. Secondary endpoints included PSA response rate, prolongation of serum PSA doubling time and time to biochemical disease progression. Results: The primary and secondary endpoints of the study were not met in the predefined analyses. In a retrospective analysis of patients with baseline PSA &lt;= 1 ng/ml and a high EpCAM expression, both the mean increase in PSA from baseline to week 24 and the PSA doubling time at week 15 were significantly improved in the high-dose adecatumumab group compared with the placebo group. Most frequent treatment-related clinical adverse events were gastrointestinal (diarrhoea and nausea) or general events (chills), showing a dose dependency but no grade 3/4 intensity in any patient. Conclusion: In men with rising PSA levels after radical prostatectomy and no evidence of clinical relapse, adecatumumab delayed disease progression in a subgroup of patients with baseline PSA levels &lt;= 1 ng/ml and high EpCAM-expressing tumours. Copyright (C) 2010 S. Karger AG, Basel},
  author       = {Marschner, Norbert and Ruettinger, Dominik and Zugmaier, Gerhard and Nemere, Gyula and Lehmann, Jan and Obrist, Peter and Baeuerle, Patrick A. and Wolf, Andreas and Schmidt, Margit and Abrahamsson, Per-Anders and Reinhardt, Carsten and Heidenreich, Axel},
  issn         = {0042-1138},
  keyword      = {Phase II study,Prostate-specific antigen,Prostate cancer,Human monoclonal antibody,MT201,Adecatumumab},
  language     = {eng},
  number       = {4},
  pages        = {386--395},
  publisher    = {Karger},
  series       = {Urologia Internationalis},
  title        = {Phase II Study of the Human Anti-Epithelial Cell Adhesion Molecule Antibody Adecatumumab in Prostate Cancer Patients with Increasing Serum Levels of Prostate-Specific Antigen after Radical Prostatectomy},
  url          = {http://dx.doi.org/10.1159/000318055},
  volume       = {85},
  year         = {2010},
}