After a median duration of follow-up of 14.5 months in the olaparib group and 14.1 months in the standard-therapy group, median PFS was significantly longer in the olaparib group than in the standard-therapy group (7.0 months vs 4.2 months; HR for disease progression or death=0.58; 95% CI, 0.43 to 0.80; p<0.001).r
Kaplan-Meier curve of progression-free survivalr
©N Engl J Med 2018
The study stratified patients for hormone receptor status, prior platinum chemotherapy, and any prior chemotherapy in the metastatic setting. Subgroup analysis showed statistically significant improvement in PFS in those with triple negative breast cancer (HR=0.43; 95% CI, 0.29 to 0.63), patients who had not received prior platinum containing chemotherapy (HR=0.60; 95% CI, 0.43 to 0.84) and those with a BRCA1 mutation (HR=0.54; 95% CI, 0.37 to 0.79).
The response rate was 59.9% in the olaparib group and 28.8% in the standard-therapy group.
An updated analysis conducted after a median follow-up of 25.3 months in the olaparib group and 26.3 months in the standard-therapy group, showed a median OS of 19.3 months vs 17.1 months respectively (HR=0.90, 95% CI, 0.66 to 1.23, p=0.513).r
Kaplan-Meier curve of overall survivalr
TPC = standard-therapy group
©Ann Oncol 2019
Health-related QOL was assessed with the use of the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). The median time to a clinically meaningful decrease in QLQ-C30 score, defined as ≥ 10 points, was not reached in the olaparib group and was 15.3 months in the standard-therapy group (HR=0.44; 95% CI, 0.25 to 0.77, p=0.004).