In an additional analysis of the 25-week randomized, placebo-controlled AFFIRM trial, researchers examined changes in Functional Assessment of cancer Therapy-Prostate (FACT-P) scores in 938 patients randomized to enzalutamide (160 mg/day) or placebo. FACT-P scores were gathered prior to randomization and at set intervals throughout the study.
Longitudinal changes were measured from baseline to 25 weeks using a mixed effects model for repeated measures (MMRM), with a secondary pattern mixture model (PMM). Cumulative distribution function (CDF) plots were applied for missing data.
The researchers found that after 25 weeks, mean FACT-P scores decreased by 1.52 in the enzalutamide group compared to 13.73 with placebo.
Additionally, significant treatment differences favoring enzalutamide were apparent in all FACT-P subscales and indices in both MMRM and PMM models. CDF plots favored the use of enzalutamide across all response levels for FACT-P scores.
In men with progressive mCRPC after docetaxel–based chemotherapy, enzalutamide is superior to placebo in health–related quality of life outcomes, regardless of analysis model or threshold selected for meaningful response.