Abstract 2491
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 with mHSPC 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), FACIT-Fatigue, 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); 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 |
|---|---|---|
| ADT+D | 0.70 | 0.37-1.34 |
| ADT | 2.51 | 1.37-4.58 |
1. Adjusted for treatment arm, disease volume, ECOG PS, Gleason, prior local therapy and BMI, and stratification factors at randomization.
Conclusions
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.
Clinical trial identification
NCT00309985.
Legal entity responsible for the study
ECOG- ACRIN.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
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.