Association between patient reported quality of life (QOL) and survival: Analysis of E3805 chemohormonal androgen ablation randomized trial in prostate cancer

Background: Chemohormonal therapy (docetaxel and androgen deprivation (ADT+D)) for metastatic hormone sensitive prostate cancer (mHSPC) prolongs overall survival (OS) versus ADT alone. We assessed the association between QOL and OS in men withmHSPC treated with ADT+D vs ADT. Methods: Men were randomized to ADT+D (6 cycles) or ADT. QOL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACITFatigue, and Brief Pain Inventory (BPI). Logrank test and Cox proportional hazards models were used to evaluate the association between QOL and OS. Results: 790 men were randomized (ADT+D, N=397, and ADT, N=393). OS was significantly poorer for ADT patients with baseline FACT-P ≤ median than > median (p=0.03), but not for ADT+D patients (p=0.34). FACT-P at 3 months was associated with OS for ADT patients (median OS lowest vs highest quartile 26.5 vs 44.1 mo, p=0.003), but not ADT+D (median OS lowest vs highest quartile 46.1 vs 48.4 mo, p=0.98 and Table). Change in QOL from baseline to 12 months in the patients with most improvement and most decline was associated with OS (median OS in best vs worst 25% in ADT 36.1 vs 23.7 mo, p=0.048; median OS in best vs worst 25% in ADT+D NR vs 37.1 mo, p=0.006). Baseline fatigue, but not baseline pain, was associated with OS after adjusting for multiple prognostic factors (BPI (p=0.86); FACITFatigue 3-unit increase HR=0.95, p=0.006). Conclusions: In men with mHSPC, baseline and 3month poor QOL are associated with OS in ADT patients but not ADT+D. The latter may be due to positive treatment effect from docetaxel in pts with poor baseline QOL. There was no association between chemotherapy induced poor QOL and OS. (Table Presented) .