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• W2580024806 endingPage "183" @default.
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• W2580024806 abstract "183 Background: In study COU-AA-301, the androgen biosynthesis inhibitor AA significantly increased overall survival in mCRPC post-docetaxel (D) in both interim and updated analyses at 552 and 775 events, respectively. Interim data also showed a significant benefit of AA on patient (pt) reported pain. We present long-term outcomes of the effect of AA on pain and SREs. Methods: In this international randomized double blind study of AA (1 g QD) + prednisone (P) (5 mg BID) vs placebo + P in mCRPC post-D, pain was assessed at baseline and each treatment cycle until treatment discontinuation using the BPI-SF questionnaire. Palliation/progression of pain intensity (P-INT) and pain interference (P-INF) were evaluated using a priori definitions. P-INT palliation was defined as ≥ 30% improvement in pt reported “worst pain in last 24 h” (on 0-10 numerical rating scale) durable for ≥ 28 d without increased analgesic use (by WHO criteria) in eligible pts (those with significant baseline pain). Conversely, P-INT progression was defined as ≥ 30% deterioration, or increased analgesic use, over ≥ 28 d. Results: 797 pts were randomized to AA + P, 398 to placebo + P. Median follow-up was 20.2 mos. Median time to SRE was 25.0 mos (AA + P) vs 20.3 mos (placebo + P), p = 0.0001. Pain data were available for most patients; the cumulative amount of missing data ranged from 5% at Cycle 1 to 7% at Cycle 20. AA + P improved P-INT outcomes (Table); P-INF benefits were similar and also highly significant. Conclusions: Benefits of AA + P observed in the interim analysis, including superior and more durable pain relief and delay of pain progression and SREs, were maintained with longer follow-up. Additional analyses of the potential relationships between pain/SREs and other outcomes, as well as of prednisone’s effect on pain palliation in the control arm, are ongoing. [Table: see text]" @default.
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• W2580024806 date "2012-02-10" @default.
• W2580024806 modified "2023-10-18" @default.
• W2580024806 title "Pain control and delay in time to skeletal-related events (SREs) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA): Long-term follow-up." @default.
• W2580024806 doi "https://doi.org/10.1200/jco.2012.30.5_suppl.183" @default.
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