Synapse - Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer

Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer Journal Article

Authors:	Manning-Geist, B. L.; Gordhandas, S. B.; Giri, D. D.; Iasonos, A.; Zhou, Q.; Girshman, J.; O'Cearbhaill, R. E.; Zamarin, D.; Lichtman, S. M.; Sabbatini, P. J.; Tew, W. P.; Li, K.; McDonnell, A. S.; Aviki, E. M.; Chi, D. S.; Aghajanian, C. A.; Grisham, R. N.
Article Title:	Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer
Abstract:	Objectives: 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. Methods: 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 (PFS6) and overall response rate (ORR) by RECIST 1.1 criteria. Results: 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 PFS6 rate (as binary) was 22% (90% CI: 15.1–100%). The 6-month PFS rate (as time to event) was 19.8% for HGS patients (90% CI: 12.7–100%) and 38.5% (90% CI: 21.7%–100%) for LGS patients. Grade 3 toxicities occurred in 6 patients (one toxicity (Grade 3 rash) was considered a dose-limiting toxicity). One patient died of cardiac arrest after 42 days on treatment of a cardiac arrest not attributed to study drug. Conclusions: The study met its primary endpoint, with a PFS6 rate of 22% (n = 13); however, the overall response rate was low. Enzalutamide was well tolerated and may be a potential treatment option in select patients. © 2021 Elsevier Inc.
Keywords:	ovarian cancer; recurrent ovarian cancer; enzalutamide; serous ovarian cancer; androgen receptor expression
Journal Title:	Gynecologic Oncology
Volume:	164
Issue:	1
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2022-01-01
Start Page:	12
End Page:	17
Language:	English
DOI:	10.1016/j.ygyno.2021.10.087
PUBMED:	34763937
PROVIDER:	scopus
PMCID:	PMC9449573
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85118843525&doi=10.1016%2fj.ygyno.2021.10.087&partnerID=40&md5=3c3b2e5a79869929241e7e7dc7a97c6e
Notes:	Article -- Export Date: 1 February 2022 -- Source: Scopus