Abstract | PURPOSE: MATERIALS AND METHODS: Patient-reported outcomes for pain and fatigue were evaluated using the Brief Pain Inventory-Short Form and Brief Fatigue Inventory. 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. RESULTS: Compliance for completing the Brief Pain Inventory-Short Form and Brief Fatigue Inventory was high (96% to 97%) in the first year. Median followup 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 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" (not estimable vs 23.0 months; p=0.0139) and " pain interfered with sleep" (28.7 vs 20.9 months; p=0.0167). Likelihood for fatigue and worsening fatigue were similar between groups. CONCLUSIONS:
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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 |
Journal | The Journal of urology
(J Urol)
Vol. 206
Issue 4
Pg. 914-923
(10 2021)
ISSN: 1527-3792 [Electronic] United States |
PMID | 34039013
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Androgen Antagonists
- Thiohydantoins
- apalutamide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Androgen Antagonists
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Cancer Pain
(diagnosis, drug therapy, etiology, psychology)
- Clinical Deterioration
- Fatigue
(diagnosis, drug therapy, etiology, psychology)
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Pain Measurement
(statistics & numerical data)
- Patient Reported Outcome Measures
- Progression-Free Survival
- Prostatic Neoplasms
(complications, drug therapy, mortality, pathology)
- Quality of Life
- Severity of Illness Index
- Thiohydantoins
(administration & dosage)
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