Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
Benzamides
/ administration & dosage
Cystadenocarcinoma, Serous
/ drug therapy
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
/ drug therapy
New York
Nitriles
/ administration & dosage
Ovarian Neoplasms
/ drug therapy
Phenylthiohydantoin
/ administration & dosage
Progression-Free Survival
Receptors, Androgen
/ metabolism
Androgen receptor expression
Enzalutamide
Ovarian cancer
Recurrent ovarian cancer
Serous ovarian cancer
Journal
Gynecologic oncology
ISSN: 1095-6859
Titre abrégé: Gynecol Oncol
Pays: United States
ID NLM: 0365304
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
30
08
2021
revised:
19
10
2021
accepted:
26
10
2021
pubmed:
13
11
2021
medline:
23
2
2022
entrez:
12
11
2021
Statut:
ppublish
Résumé
We sought to determine the safety and efficacy of the oral androgen receptor antagonist enzalutamide in patients with previously treated, recurrent, AR-positive (AR+) ovarian cancer. This was a single-institution phase II study of patients with AR+ ovarian cancer with measurable disease with 1-3 prior lines of chemotherapy; patients were screened for enrollment from 11/2013-7/2018. Following consent, archival tissue was evaluated for AR+. Enrolled patients received daily enzalutamide 160 mg until progression of disease or treatment discontinuation. Adverse events were graded by CTCAE v4.0. Co-primary endpoints were 6-month progression-free survival (PFS During the study period, 160 patients were screened and 59 (45 high-grade serous [HGS] and 14 low-grade serous [LGS]) consented to treatment on study. There was 1 confirmed and 1 unconfirmed partial response. The ORR was 1.7% (90% CI: 0.2-100%). The overall PFS The study met its primary endpoint, with a PFS
Identifiants
pubmed: 34763937
pii: S0090-8258(21)01551-1
doi: 10.1016/j.ygyno.2021.10.087
pmc: PMC9449573
mid: NIHMS1828696
pii:
doi:
Substances chimiques
Benzamides
0
Nitriles
0
Receptors, Androgen
0
Phenylthiohydantoin
2010-15-3
enzalutamide
93T0T9GKNU
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
12-17Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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