SOLO-1: Maintenance Olaparib in Newly Diagnosed Advanced Ovarian Cancer

Title: Maintenance Olaparib in Newly Diagnosed Advanced Ovarian Cancer

Hypothesis: Maintenance PARP-i after initial therapy in high-grade ovarian carcinoma improves progression free survival.

Standard Arm: Placebo

Experimental Arm: Olaparib 300 mg bid daily x 2 years

Design: Double blinded randomized controlled phase 3 study

Inclusion Criteria: High-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer with mutation in BRCA1, BRCA2 (germline or somatic)

Primary Endpoint: PFS or death at 3 years

Outcomes: Experimental vs. Standard arm (p-value)

PFS/death at 3 years: 60% vs. 27% (p<0.001)

Median time to subsequent therapy: 51.8 months vs. 15.1 months (HR – 0.30, p<0.001)

Serious Adverse Events:Experimental vs. Standard arm (p-value)

Anemia (G3/G4): 22% vs. 2% (p=s.s.)

Neutropenia (G3/G4): 9% vs. 5% (p=s.s.)

AML: 3/260 (1%) vs. 0/130 (0%) (p=n.s)

New Primary Cancer: 5/260 (2%) vs. 3/130 (2%) (p=n.s.)

Pneumonitis/Interstitial Lung Disease: 5/260 (2%) vs. 0 (p=n.s)

Conclusion: Addition of Olaparib 300mg bid for two years maintenance after completion of primary chemotherapy and debulking surgery in BRCA 1/2 (both germline or somatic) increases progression free survival or risk of death at 3 years.