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.
Enzalutamide improves quality of life outcomes in progressive mCRPC.
This study aims to present longitudinal changes in Functional Assessment of Cancer Therapy–Prostate (FACT–P) scores during 25–week treatment with enzalutamide or placebo in men with progressive metastatic castration–resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial.
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.
From Mdlinx
