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.
The Journal of urology. 2021 May 27 [Epub ahead of print]
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
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., Janssen Research & Developmen, Horsham, Pennsylvania., Skåne University Hospital, Lund University, Malmö, Sweden., Guy's, King's, and St Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK., Liga Norte Riograndense Contra O Câncer, Natal, Brazil., Yonsei University College of Medicine and Gangnam Severance Hospital, Seoul, South Korea., Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey., Hospital Universitario de Jerez de la Frontera, Cadiz, Spain., University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany., Kindai University Faculty of Medicine, Osaka, Japan., Fudan University Shanghai Cancer Center, Shanghai, China., Urology of Virginia, Eastern Virginia Medical School, Norfolk, Virginia., University of North Carolina, Chapel Hill, North Carolina., Janssen Research & Development, San Diego, California., Janssen Research & Development, Los Angeles, California., BC Cancer, Vancouver, BC, Canada.