1. Phase II study of enzalutamide in androgen receptor positive, recurrent, high- and low-grade serous ovarian cancer.
- Author
-
Manning-Geist BL, Gordhandas SB, Giri DD, Iasonos A, Zhou Q, Girshman J, O'Cearbhaill RE, Zamarin D, Lichtman SM, Sabbatini PJ, Tew WP, Li K, McDonnell AS, Aviki EM, Chi DS, Aghajanian CA, and Grisham RN
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Benzamides administration & dosage, Cystadenocarcinoma, Serous mortality, Cystadenocarcinoma, Serous pathology, Female, Humans, Middle Aged, Neoplasm Recurrence, Local pathology, New York, Nitriles administration & dosage, Ovarian Neoplasms mortality, Ovarian Neoplasms pathology, Phenylthiohydantoin administration & dosage, Progression-Free Survival, Receptors, Androgen metabolism, Benzamides therapeutic use, Cystadenocarcinoma, Serous drug therapy, Neoplasm Recurrence, Local drug therapy, Nitriles therapeutic use, Ovarian Neoplasms drug therapy, Phenylthiohydantoin therapeutic use
- 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 (PFS
6 ) 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., (Copyright © 2021 Elsevier Inc. All rights reserved.)- Published
- 2022
- Full Text
- View/download PDF