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PAOLA-1

Olaparib Plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Date of Publication:

December 19, 2019

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/31851799/
Hypothesis:

Will the addition of olaparib to bevacizumab frontline maintenance improve PFS in an unselected population of advanced ovarian cancer patients?

Control Arm(s):

Placebo PO BID

bevacizumab 15mg/kg q3w for 15 months

Experimental Arm(s):

Olaparib 300mg PO BID

bevacizumab 15mg/kg q3w for 15 months

Primary End Point:

PFS

Inclusion Criteria:

High-grade serous or endometrioid ovarian cancer

Primary treatment with bevacizumab resulting in NED, CR, or PR.

Exclusion Criteria:

Delays due to hematologic toxicity during primary treatment.

Results:

Olaparib + Bev vs Placebo + Bev:

median PFS, all: 22.1 vs. 16.6 (SS)    

median PFS, BRCAm: 37.2 vs. 21.7 (SS)    

median PFS, HRD: 28.1 vs. 16.6 (SS)    

median PFS, HR proficient/unknown:16.9 vs. 16.0 (NS)

Anemia, fatigue, nausea more common in olaparib arm.

Grade 3 HTN: 19% vs 30%

Discontinuation 20% vs. 6%

Conclusions:

Olaparib added to frontline bevacizumab maintenance prolonged PFS in unselected cohort of patients with advanced ovarian cancer. Greatest benefit seem in BRCAm or HRD patients.

Reviewer:
Ross Harrison, OTF