Centralized independent disease status adjudication for maintenance treatment evaluation in advanced ovarian cancer setting: A critical analysis of the MIMOSA trial experience.

e16510^ Background: Progression free survival (PFS) is an accepted surrogate of Overall Survival (OS) often used as the primary endpoint in phase III trials evaluating maintenance treatment in advanced ovarian cancer (AOC). Methods: We compare the centrally assessed PFS (PFS-CA) vsthe locally assessed PFS (PFS-LA) data collected in the Mimosa Trial, a randomized, double blind, placebo controlled, Phase III study of Abagovomab maintenance therapy in AOC patients in complete response after standard chemotherapy. PFS was assessed at pre-fixed time points by pelvis/abdomen CT scan, which were centrally and blinded reviewed by trained radiologists for radiological assessment (RA) of recurrence status and date (PFS-RA). An independent blinded committee, including one radiologist and one oncologist, reviewed all the CT scans and any additional imaging records AND/OR clinical data (when locally required for patients’management) to adjudicate the recurrence status and date (PFS-CA). PFS-CA was used for the primary...