Secondary Endpoint (response by ORR and pCR)
PD, tumor, SD, Tumor
DISEASE PROGRESSION, DISEASE, TUMOR, TUMOR
All ORR was determined by RECIST 1.1. Objective response was achieved in 4 patients (10.3% of the entire cohort); one with complete and 3 with partial responses (PR), while stable disease (SD) was observed in 28 (71.8%) and progressive disease (PD) in 6 patients (15.4%). There were 6 patients who developed disease progression: 3 in the no treatment arm, 1 in C-Olaparib, and 2 in D-Olaparib. Tumor response was not evaluated in 1 patient in the Olaparib only arm who underwent surgery earlier than scheduled and was unable to proceed for reevaluation. The ORR among treated patients evaluable for response (pCR was observed in 2 patients; 1 treated with D-Olaparib who also achieved a complete response (CR) and 1 in the C-Olaparib arm. One patient in the Olaparib only arm attained almost pCR (3 mm tumor was detected in surgical biopsy). Thirteen treated patients (38.2%) attained pathologic downstaging.