PMID- 31473120
OWN - NLM
STAT- MEDLINE
DCOM- 20200706
LR  - 20211204
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 17
IP  - 6
DP  - 2019 Dec
TI  - Results of a Real-world Study of Enzalutamide and Abiraterone Acetate With 
      Prednisone Tolerability (REAAcT).
PG  - 457-463.e6
LID - S1558-7673(19)30245-9 [pii]
LID - 10.1016/j.clgc.2019.07.017 [doi]
AB  - BACKGROUND: The objective of this study was to evaluate differences in 
      tolerability in patients with metastatic castration-resistant prostate cancer 
      treated with enzalutamide (ENZA) or abiraterone acetate plus prednisone (AA+P). 
      PATIENTS AND METHODS: This was a phase IV, prospective, open-label, multicenter, 
      real-world study. Patients were prescribed ENZA or AA+P at the treating 
      physician's discretion. Computerized tests of 4 cognitive domains (Cogstate), 
      patient-reported outcomes (European Organisation for Research and Treatment of 
      Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-30], Functional 
      Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], Functional 
      Assessment of Cancer Therapy-Cognitive Function [FACT-Cog]), and 
      patient/caregiver surveys were assessed at baseline and 2 months. Safety data 
      were collected. RESULTS: Of 100 treated patients, 92 were evaluable (46/arm). 
      Baseline characteristics were similar, with mild cognitive impairment observed in 
       approximately 20% of patients. The FACIT-Fatigue demonstrated a statistically significant 
      worsening from baseline of -4.00 (95% confidence interval, -6.61 to -1.39) for 
      ENZA compared with AA+P, -0.01 (95% confidence interval, -2.40 to 2.38). Overall, 
      more adverse events (AEs) and more AEs of fatigue were reported with ENZA versus 
      AA+P (52% vs. 36% and 26% vs. 8%, respectively). Grade 3/4 AEs were similar (4% 
      vs. 6%). Unique neuropsychiatric AEs reported with ENZA included amnesia, 
      cognitive disorders, memory impairment, and confusional state; those for AA+P 
      included cerebrovascular accident, presyncope, and spinal cord compression. 
      Clinically meaningful cognitive decline was seen in 4 patients on ENZA versus 1 
      patient on AA+P. However, the overall mean changes from baseline for the Cogstate 
      tests, the EORTC QLQ-C30, and the FACT-Cog assessment were similar and showed no 
      meaningful change. Caregiver survey responses noted more fatigue with ENZA and 
      more moodiness with AA+P compared with patient responses. CONCLUSIONS: Although 
      baseline values were similar, more fatigue and neurocognitive differences were 
      observed with ENZA compared with AA+P.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Shore, Neal D
AU  - Shore ND
AD  - Carolina Urologic Research Center, Myrtle Beach, SC. Electronic address: 
      nshore@gsuro.com.
FAU - Saltzstein, Daniel
AU  - Saltzstein D
AD  - Urology San Antonio, San Antonio, TX.
FAU - Sieber, Paul
AU  - Sieber P
AD  - Lancaster Urology, Lancaster, PA.
FAU - Mehlhaff, Bryan
AU  - Mehlhaff B
AD  - Oregon Urology Institute, Springfield, OR.
FAU - Gervasi, Lawrence
AU  - Gervasi L
AD  - SouthWest Urology, Cleveland, OH.
FAU - Phillips, Jennifer
AU  - Phillips J
AD  - Janssen Scientific Affairs, LLC, Horsham, PA.
FAU - Wong, Yu-Ning
AU  - Wong YN
AD  - Janssen Scientific Affairs, LLC, Horsham, PA.
FAU - Pei, Huiling
AU  - Pei H
AD  - Janssen Research & Development, LLC, Spring House, PA.
FAU - McGowan, Tracy
AU  - McGowan T
AD  - Janssen Scientific Affairs, LLC, Horsham, PA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190806
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Benzamides)
RN  - 0 (Nitriles)
RN  - 2010-15-3 (Phenylthiohydantoin)
RN  - 93T0T9GKNU (enzalutamide)
RN  - EM5OCB9YJ6 (Abiraterone Acetate)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Abiraterone Acetate/*adverse effects
MH  - Affect/drug effects
MH  - Aged
MH  - Aged, 80 and over
MH  - Amnesia/chemically induced/epidemiology
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects
MH  - Benzamides
MH  - Caregivers/statistics & numerical data
MH  - Cognitive Dysfunction/chemically induced/epidemiology
MH  - Confusion/chemically induced/epidemiology
MH  - Fatigue/chemically induced/epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Phenylthiohydantoin/adverse effects/*analogs & derivatives
MH  - Prednisone/*adverse effects
MH  - Prospective Studies
MH  - Prostatic Neoplasms, Castration-Resistant/*drug therapy/pathology
MH  - Quality of Life
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical trial
OT  - Phase IV
OT  - Prospective
OT  - Prostatic neoplasms
OT  - mCRPC
EDAT- 2019/09/02 06:00
MHDA- 2020/07/07 06:00
CRDT- 2019/09/02 06:00
PHST- 2019/04/17 00:00 [received]
PHST- 2019/07/19 00:00 [revised]
PHST- 2019/07/28 00:00 [accepted]
PHST- 2019/09/02 06:00 [pubmed]
PHST- 2020/07/07 06:00 [medline]
PHST- 2019/09/02 06:00 [entrez]
AID - S1558-7673(19)30245-9 [pii]
AID - 10.1016/j.clgc.2019.07.017 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2019 Dec;17(6):457-463.e6. doi: 
      10.1016/j.clgc.2019.07.017. Epub 2019 Aug 6.