Apalutamide Plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study.

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Exploratory analysis of prostate cancer-related pain and fatigue on health-related quality of life in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving apalutamide (240 mg/day) or placebo, with continuous androgen-deprivation therapy (ADT), in the phase 3, randomized, double-blind placebo-controlled TITAN trial (NCT02489318).Patient-reported outcomes for pain and fatigue were evaluated using the Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory (BFI). Time to deterioration (TTD) was estimated by Kaplan-Meier method; hazard ratios and 95% confidence intervals were calculated using Cox proportional-hazards model. General estimating equations for logistic regression estimated treatment-related differences in the likelihood of worsening pain or fatigue.Compliance for completing the BPI-SF and BFI was high (96% to 97%) in the first year. Median follow-up times were similar between treatments (19 to 22 months). Median pain TTD was longer with apalutamide than placebo for “pain at its least in the last 24 hours” (28.7 vs 21.8 months, respectively; p=0.0146), “pain interfered with mood” (not estimable [NE] vs 22.4 months; p=0.0017), “pain interfered with walking ability” (28.7 vs 20.2 months; p=0.0027), “pain interfered with relations” (NE vs 23.0 months; p=0.0139), “pain interfered with sleep” (28.7 vs 20.9 months; p=0.0167). Likelihood for fatigue and worsening fatigue was similar between groups.mCSPC patients receiving apalutamide plus ADT vs placebo plus ADT reported consistently favorable TTD of pain. No difference for change in fatigue was observed with apalutamide vs placebo.

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Authors: Neeraj Agarwal, Kelly McQuarrie, Anders Bjartell, Simon Chowdhury, Andrea J Pereira de Santana Gomes, Byung Ha Chung, Mustafa Özgüroğlu, Álvaro Juárez Soto, Axel S Merseburger, Hirotsugu Uemura, Dingwei Ye, Robert Given, Ethan Basch, Branko Miladinovic, Angela Lopez-Gitlitz, Kim N Chi