Abstract
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 ∼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.
Keywords
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Article info
Publication history
Published online: August 06, 2019
Accepted:
July 28,
2019
Received in revised form:
July 19,
2019
Received:
April 17,
2019
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
