ChemoID-guided therapy improves objective response rate in recurrent platinum-resistant ovarian cancer randomized clinical trial.

Abstract

Patients with recurrent platinum-resistant ovarian cancer (PROC) have poor clinical outcomes, owing mainly to the presence of therapy-resistant cancer stem cells (CSCs). The NCT03949283 randomized clinical trial enrolled patients with recurrent PROC to receive ChemoID-guided chemotherapy or the best physician-choice regimen selected from the same list of thirteen mono or combination chemotherapies. The primary outcome was objective response rate (ORR) assessed on CT scans using the RECIST 1.1 criteria at 6 months follow-up. Subjects treated with the ChemoID assay had an ORR of 55% (CI₉₅ 39% - 73%), compared to 5% (CI₉₅ 0% - 11%) for those treated with physician's choice chemotherapy (p <0.0001). Secondary endpoints of duration of response (DOR) and progression-free survival (PFS) of subjects treated with chemotherapies guided by the ChemoID assay versus physician's choice chemotherapy were a median of 8 months vs. 5.5 months (p <0.0001), and 11.0 months (CI₉₅ 8.0- NA) vs 3.0 months (CI₉₅ 2.0- 3.5) with 27% of hazard ratio (CI95, 0.15-0.49; p <0.001), respectively.