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Denosumab and Bone Metastasis–Free Survival in Men With Nonmetastatic Castration-Resistant Prostate Cancer: Exploratory Analyses by Baseline Prostate-Specific Antigen Doubling Time
Author(s) -
Matthew R. Smith,
Fred Saad,
Stéphane Oudard,
Neal D. Shore,
Karim Fizazi,
Paul Sieber,
Bertrand Tombal,
Ronaldo Damião,
Gavin Marx,
Kurt Miller,
Peter J. Van Veldhuizen,
Juan Moróte,
Zhishen Ye,
Roger Dansey,
Carsten Goessl
Publication year - 2013
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.2012.44.6716
Subject(s) - denosumab , medicine , prostate cancer , hazard ratio , doubling time , bone metastasis , prostate specific antigen , urology , metastasis , prostate , oncology , cancer , surgery , osteoporosis , confidence interval , biochemistry , in vitro , chemistry
Denosumab, an anti-RANK ligand monoclonal antibody, significantly increases bone metastasis-free survival (BMFS; hazard ratio [HR], 0.85; P = .028) and delays time to first bone metastasis in men with nonmetastatic castration-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) ≥ 8.0 ng/mL and/or PSA doubling time (PSADT) ≤ 10.0 months. To identify men at greatest risk for bone metastasis or death, we evaluated relationships between PSA and PSADT with BMFS in the placebo group and the efficacy and safety of denosumab in men with PSADT ≤ 10, ≤ 6, and ≤ 4 months.

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