Abstract | BACKGROUND: 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:
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Authors | Norbert Marschner, Dominik Rüttinger, Gerhard Zugmaier, Gyula Nemere, Jan Lehmann, Peter Obrist, Patrick A Baeuerle, Andreas Wolf, Margit Schmidt, Per-Anders Abrahamsson, Carsten Reinhardt, Axel Heidenreich |
Journal | Urologia internationalis
(Urol Int)
Vol. 85
Issue 4
Pg. 386-95
( 2010)
ISSN: 1423-0399 [Electronic] Switzerland |
PMID | 20606402
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2010 S. Karger AG, Basel. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antigens, Neoplasm
- Antineoplastic Agents
- Cell Adhesion Molecules
- EPCAM protein, human
- Epithelial Cell Adhesion Molecule
- adecatumumab
- Prostate-Specific Antigen
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Topics |
- Aged
- Antibodies, Monoclonal
(adverse effects, pharmacokinetics, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antigens, Neoplasm
(immunology)
- Antineoplastic Agents
(adverse effects, pharmacokinetics, therapeutic use)
- Cell Adhesion Molecules
(adverse effects, antagonists & inhibitors, immunology, pharmacokinetics, therapeutic use)
- Double-Blind Method
- Epithelial Cell Adhesion Molecule
- Europe
- Humans
- Male
- Middle Aged
- Placebo Effect
- Prostate-Specific Antigen
(blood)
- Prostatectomy
- Prostatic Neoplasms
(blood, drug therapy, immunology, surgery)
- Retrospective Studies
- Time Factors
- Treatment Outcome
- Up-Regulation
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