38 Phase II study of enzalutamide in androgen receptor positive (AR+) recurrent ovarian cancer: final results

Objectives This was a single institution, phase II, Simon 2-stage with safety lead-in study of the oral androgen-receptor antagonist, enzalutamide, in patients with recurrent AR+ ovarian cancer with measurable disease and 1–3 prior lines of chemotherapy. The primary objective was to determine the proportion of patients surviving progression free for 6 months (PFS6) and overall response rate by RECIST 1.1 Criteria; with 7/58 responses or PFS6 of 13 being considered a positive study.Methods Following consent, archival tissue was screened for AR+ by IHC with ≥5% considered positive. Enrolled patients were treated with enzalutamide 160mg po daily until progression of disease or treatment discontinuation. A cycle was 28 days. Adverse events were graded by CTCAE V 4.0.Results Between 11/2013–7/2018 160 patients were screened and 59 patients [45 high grade serous(HGS), 14 low grade serous(LGS …