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 with mHSPC treated with ADT+D vs ADT.
Men were randomized to ADT+D (6 cycles) or ADT. QOL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACIT-Fatigue, and Brief Pain Inventory (BPI). Logrank test and Cox proportional hazards models were used to evaluate the association between QOL and OS.
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); FACIT-Fatigue 3-unit increase HR = 0.95, p = 0.006).Table: 832P
Association between 3-month FACT-P and OS (worst 25% and best 25% of patients)
|Treatment||HR (worst 25% vs best 25%)1||95% CI|
1. Adjusted for treatment arm, disease volume, ECOG PS, Gleason, prior local therapy and BMI, and stratification factors at randomization.
In men with mHSPC, baseline and 3 month 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.
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A.K. Morgans: Honoaria: Sanofi, Janssen, AstraZeneca, Genentech. C. Sweeney: Consultant: Genentech/Roche, Sanofi, Janssen, Pfizer, Astellas, Bayer, Tomar, Leuchemix. Research: Sanofi, Janssen, Pfizer, Astellas, Bayer. All other authors have declared no conflicts of interest.