Page 11 - CUA2019 Abstracts - Oncology-Prostate

2019 CUA Abstracts

tions of bone metastases contribute to morbidity, pain, and death. In this (Table 1). There was a 31% lower risk of radiographic progression in
exploratory post-hoc analysis of PREVAIL, we analyzed clinical outcomes PBO + BTT vs. PBO alone (0.69 [0.52, 0.93]; p=0.0075), and the risk
associated with bone-targeted therapies (BTT) and ENZA vs. ENZA alone. of death was similar between PBO + BTT and PBO alone (0.90 [0.69,
Methods: The phase 3 PREVAIL study (NCT01212991) randomized 1.19]; p=0.2669). The risk of ECOG PS deterioration was similar between
men with mCRPC 1:1 to ENZA (160 mg) or placebo (PBO) with con- ENZA + BTT and ENZA alone (p=0.6367), and between PBO + BTT and
tinued androgen-deprivation therapy. Target population was men with PBO alone (p=0.3615).
bone metastases at baseline, grouped by pre-study baseline BTT use. Conclusions: Pre-study BTT use with ENZA was not associated with
Co-primary endpoints were rPFS and OS. Eastern Cooperative Oncology improved clinical outcomes vs. ENZA alone. rPFS was improved in men
Group performance status (ECOG PS) deterioration was defined as time taking PBO + BTT vs. PBO alone. These results suggest that BTTs do
from randomization to first evidence of ECOG PS deterioration by ≥1 not improve outcomes in combination with first-line ENZA in mCRPC.
grade. Results are presented as hazard ratio (HR) (95% confidence inter- Further analysis of optimal timing and combinations when using BTTs
val [CI]). remains relevant.
Results: Of 1429 men, 410 had pre-study BTT use. The risk of radio- This paper has a figure, which may be viewed online at:
graphic progression was similar between ENZA + BTT and ENZA alone https://2019.cua.events/webapp/lecture/36
(HR [95% CI] 1.05 [0.69, 1.60]; p=0.4408), whereas the risk of death
was higher in ENZA + BTT vs. ENZA alone (1.44 [1.08, 1.92]; p=0.0076)

S122 CUAJ • June 2019 • Volume 13, Issue 6(Suppl5)