Phase II clinical trial of eribulin (E) in advanced/recurrent cervical cancer.

5526Background: Eribulin (E), a Halichondrin B analog from the marine sponge H. okadai has clinical efficacy in pretreated metastatic breast cancer patients (pts) and preclinical antitumor activity in squamous cell carcinoma (SCC). We conducted a 2-stage Phase 2 study of E in pts with advanced/recurrent CC to examine its clinical activity and evaluate potential predictors of response. Methods: Pts with advanced/recurrent CC after ≤1 prior CT regimens, measurable disease and ECOG performance status ≤2 were treated with E (1.4mg/m2 IV day 1 and 8, every 21 days) with tumor assessments every 2 cycles. Primary endpoint was 6-month progression-free survival PFS6; secondary were best overall response (RECISTv1.1), toxicity (CTCAEv4.03) and overall survival (OS); and exploratory were associations of tumor and serum GRP78 as well as apoptosis/proliferation markers, unfolded protein response markers and tubulin sub-types with clinical activity. 30 evaluable pts would ensure 80% power when the true PFS6= 26% with a...