aBSI Is of Prognostic Significance in Castration-resistant Prostate Cancer
An automated bone scan index at baseline is clinically validated as a prognostic biomarker in men with castration-resistant prostate with bone metastases.
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An automated bone scan index (aBSI) at baseline is clinically validated as a prognostic biomarker in men with castration-resistant prostate cancer (CRPC) with bone metastases, according to data from a phase 3 study presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The data were reported by Andrew J. Armstrong, MD, of the Duke Cancer Institute in Raleigh, North Carolina.
Researchers used whole body scans acquired at screening from 1245 men with chemotherapy-naïve metastatic CRPC who were enrolled on this phase 3 trial (ClinicalTrials.gov Identifier: NCT01234311) to receive tasquinimod or placebo.
Imaging quality of all scans generated at the 241 trial sites was assessed and analyzed using EXINI boneBSI version 2 software. The aBSI results were blindly associated with outcomes.
Based on patient characteristics at baseline and overall survival (OS) outcomes, the aBSI population of 721 patients was representative of the entire study population.
Median aBSI was 1.07. Analyses by quartiles of aBSI population showed that quartile 1 (Q1) was associated with the highest OS.
Baseline aBSI was also significantly associated with survival (hazard ratio, 1.2 per doubling of BSI; P < .0001) and remained significant after adjusting for treatment, prostate-specific antigen (PSA), C-reactive protein, and lactate dehydrogenase.
“This is the largest study to date to demonstrate clinically important outcomes associated with increasing BSI,” Dr Armstrong said. “aBSI can be considered for clinical trial eligibility and risk stratification based on these defined thresholds and may be promising as an endpoint.”
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- Armstrong AJ, Edenbrandt L, Bondesson E, et al. Phase 3 prognostic analysis of the automated bone scan index (aBSI) in men with bone-metastatic castration-resistant prostate cancer (CRPC). J Clin Oncol. 2017;35(suppl; abstr 5006).