GYOEDU

SOLO-1

Maintenance Olaparib in Newly Diagnosed Advanced Ovarian Cancer

Date of Publication:

December 10, 2018

Pubmed Link:

https://www.ncbi.nlm.nih.gov/pubmed/30345884

Hypothesis:

Does the addition of maintenance PARPi after initial therapy in high-grade ovarian carcinoma improve progression free survival?

Control Arm(s):

Placebo

Experimental Arm(s):

Olaparib 300 mg PO bid x 2 years

Primary End Point:

PFS

Inclusion Criteria:

High-grade serous or endometrioid ovarian cancer

mutation in BRCA1, BRCA2 (germline or somatic)

Exclusion Criteria:

Results:

Olaparib vs Placebo:

median f/u: 41 mos

3yrs PFS: 60% vs. 27% (SS)

Median time to subsequent therapy: 51.8 vs 15.1 months (SS)

Anemia G3/G4: 22% vs. 2% (SS)

Neutropenia G3/G4: 9% vs. 5% (SS)

AML: 1% vs. 0% (NS)

New Primary Cancer: 2% vs 2% (NS)

Pneumonitis/Interstitial Lung Disease: 2% vs. 0% (NS)

Conclusions:

Addition of Olaparib for two years maintenance after completion of primary chemotherapy and debulking surgery in BRCA 1/2 (both germline or somatic) improves progression free survival.

Reviewer:

Shitanshu Uppal, OTF