RT Journal Article
T1 Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study
A1 Agarwal, Neeraj
A1 McQuarrie, Kelly
A1 Bjartell, Anders
A1 Chowdhury, Simon
A1 Pereira de Santana Gomes, Andrea J.
A1 Chung, Byung Ha
A1 Ozguroglu, Mustafa
A1 Juarez Soto, Alvaro
A1 Merseburger, Axel S.
A1 Uemura, Hirotsugu
A1 Ye, Dingwei
A1 Given, Robert
A1 Basch, Ethan
A1 Miladinovic, Branko
A1 Lopez-Gitlitz, Angela
A1 Chi, Kim N.
K1 apalutamide
K1 quality of life
K1 prostatic neoplasms
K1 neoplasm metastasis
K1 Chemotherapy-naive patients
K1 Abiraterone acetate
K1 Double-blind
K1 Prednisone
K1 Patient
K1 Men
AB Purpose: We performed an exploratory analysis of prostate cancer-related pain and fatigue on health-related quality of life in patients with metastatic castration-sensitive prostate cancer 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).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: Patients with metastatic castration-sensitive prostate cancer 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.
PB Lippincott williams & wilkins
SN 0022-5347
YR 2021
FD 2021-10-01
LK https://hdl.handle.net/10668/25041
UL https://hdl.handle.net/10668/25041
LA en
DS RISalud
RD Apr 4, 2025