Trial Outcomes & Findings for A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. (NCT NCT03106987)

This study was conducted at study centres in 11 countries (France, Italy, Spain, Germany, Poland, Belgium, Denmark, Israel, United Kingdom, Norway, and Canada) between 8-Jun-2017 and 15-Feb-2021.

Patients were randomised into 1 of 2 cohorts depending on their known BRCA1/2 status (BRCA1/2 +ve or BRCA1/2-ve). Within each cohort, patients were randomised in a 2 Olaparib:1 placebo ratio. Randomisation was stratified by prior use of bevacizumab and number of prior regimens of platinum-containing chemotherapy.

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

PFS (per RECIST 1.1) was defined as the time from randomisation until the date of Investigator assessed objective radiological disease progression or death (by any cause in the absence of disease progression). Objective progression (per RECIST 1.1) is defined as at least a 20% increase in the sum of the diameters of the target lesions and an absolute increase of \>5 mm, or an overall non-target lesion assessment of progression or a new lesion. Patients who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.

OS was defined as the time from the date of randomisation until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive

Time to progression by RECIST or CA-125 or death is defined as the time from randomisation to the earlier date of RECIST progression or CA-125 progression or death by any cause. Patients without a CA-125 progression or a RECIST progression who are still alive at the time of analysis will be censored at the time of their last evaluable RECIST assessment and/or their last available CA-125 measurement, whichever is the earliest at the time of analysis. Patients that do not have any evaluable RECIST assessments or any CA-125 results post-randomisation will be censored at the date of randomisation

TFST was assessed as time from randomisation to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment. Any patient not known to have had a further subsequent therapy or death was censored at the last known time to have not received subsequent therapy

TSST was assessed as time from randomisation to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment. Any patient not known to have had a further second subsequent therapy or death was censored at the last known time to have not received second subsequent therapy

TDT was assessed as time from randomisation to study treatment discontinuation or death if this occurs before discontinuation of study treatment. Any patient not known to have died at the time of analysis and not known to have discontinued study treatment was censored based on the last recorded date on which the patient was known to be alive

Health related quality of life (HRQoL) of Olaparib maintenance retreatment compared to placebo as measured by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) was determined. HRQoL was analysed using the FACT-O tool by mixed model for repeated measures (MMRM) analysis of the change from baseline in TOI score. FACT-O TOI is scored from O to 100 with higher scores denoting better quality of life. The higher the score, the better the HRQoL.

All AEs/serious adverse events (SAEs) reported during the study were recorded.

All AESIs reported during the study were recorded.