RECIST-assessed ORRs and duration of response were not
statistically different between the olaparib and PLD groups. Both
the CA-125–assessed ORR and the combined RECIST and/or
GCIG response rates were observed to be higher in the olaparib
400-mg group than in the olaparib 200-mg group and the PLD
group; there were no adjustments for multiple comparisons. These
findings concur with observations from earlier phase I and II
studies of patients with advanced ovarian cancer and BRCA1/2
mutations11,13 and suggest the existence of a dose-response relationship;
however, this study was not formally powered to address
this. Because only 33 deaths (26%) had occurred at the time of data
cutoff, the OS results are inconclusive.