학술논문

Bone Biomarkers and Subsequent Survival in Men with Hormone-sensitive Prostate Cancer: Results from the SWOG S1216 Phase 3 Trial of Androgen Deprivation Therapy with or Without Orteronel
Document Type
article
Source
European Urology. 85(2)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Oncology and Carcinogenesis
Clinical Research
Cancer
Aging
Urologic Diseases
Prostate Cancer
Precision Medicine
Prevention
Clinical Trials and Supportive Activities
Detection
screening and diagnosis
4.2 Evaluation of markers and technologies
4.1 Discovery and preclinical testing of markers and technologies
Male
Humans
Prostatic Neoplasms
Androgen Antagonists
Androgens
Biomarkers
Prostatic Neoplasms
Castration-Resistant
Biomarkers
Tumor
Imidazoles
Naphthalenes
Prostate cancer
Bone turnover
Overall survival
Prognostic
Predictive
Hormone sensitive
Urology & Nephrology
Clinical sciences
Language
Abstract
BackgroundBone biomarkers are strongly prognostic for overall survival (OS) in men with castration-resistant prostate cancer but not fully established for hormone-sensitive prostate cancer (HSPC).ObjectiveBone biomarkers in HSPC were prospectively evaluated as part of a phase 3 study of androgen deprivation therapy ± the CYP17 inhibitor orteronel.Design, setting, and participantsPatients were randomly divided into training (n = 316) and validation (n = 633) sets. Recursive partitioning and Cox proportional hazard models were employed.Outcome measurements and statistical analysisBone resorption (C-telopeptide and pyridinoline) and bone formation markers (C-terminal collagen propeptide and bone alkaline phosphatase) were assessed from patient sera.Results and limitationsOf 1279 men, 949 had evaluable baseline bone biomarkers. Optimal cutoffs were identified to define elevated levels of each of the four biomarkers (all p