- Over a third of patients with metastatic castration-resistant prostate cancer (mCRPC) in the PREVAIL and AFFIRM trials experienced skeletal-related events (SREs).
- First SREs was significantly associated with functional decline and reduced health-related QoL (HRQoL).
- Spinal cord compression had the largest effect on HRQoL.
Why this matters
- Delaying SREs is an important treatment goal in patients with mCRPC without major cancer-related symptoms in the chemotherapy-naïve setting.
- In PREVAIL, 587 (34.2%) patients experienced ≥1 SRE.
- First SREs caused clinically meaningful declines in EQ-5D utility index.
- Spinal cord compression had the largest effect on utility index (trajectory-adjusted mean change [TAMC], −0.24) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score (TAMC, –16.95).
- In AFFIRM, 421 (35.1%) experienced ≥1 SRE.
- There were clinically meaningful and statistically significant declines in FACT-P and FACT-General total scores after any SRE (TAMC, –6.94 and –5.46, respectively), and clinically meaningful declines in FACT-P prostate cancer subscale for spinal cord compression only (TAMC, –2.66).
- Secondary endpoint data from PREVAIL and AFFIRM trials.
- Funding: Astellas Pharma and Medivation.
- HRQoL available for more enzalutamide than placebo patients in both trials.