- Cediranib+olaparib significantly extends PFS in patients with relapsed platinum-sensitive ovarian cancer vs olaparib alone.
- PFS and OS benefit was observed in patients with wild-type germline BRCA (gBRCA), but not in BRCA mutated patients.
Why this matters
- Results call for further evaluation in wild-type gBRCA patients.
- Randomized, open-label, phase 2 study.
- 90 patients with relapsed platinum-sensitive ovarian cancer of high-grade serous/endometrioid histology or deleterious gBRCA1/2 mutation (gBRCAm) were randomly assigned to receive olaparib or cediranib+olaparib until disease progression.
- Funding: National Cancer Institute; National Institutes of Health.
- Median follow-up, 46 months.
- Median PFS was significantly longer with cediranib+olaparib vs olaparib alone (16.5 vs 8.2 months; HR, 0.50; P=.006).
- OS was not statistically different in the overall population (44.2 vs 33.3 months; HR, 0.64; P=.11).
- In gBRCA wild-type/unknown patients, cediranib+olaparib significantly improved PFS (23.7 vs 5.7 months; P=.0013) and OS (37.8 vs 23.0 months; P=.047).
- In gBRCA mutated patients, PFS and OS were similar between 2 groups.
- Treatment-related toxicities were more common with cediranib+olaparib vs olaparib alone (478 vs 180 events).
- Most common grade 3/4 adverse events with cediranib/olaparib were fatigue, diarrhea, and hypertension.
- Open label design; small size.