Ovarian Cancer

Efficacy of Maintenance Olaparib for Patients with Newly Diagnosed Advanced Ovarian Cancer with a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial

In the October 20, 2020 edition of Journal of Clinical Oncology, Paul DiSilvestro and colleagues reported on the results of the SOLO1 trial.


In SOLO1 trial, maintenance olaparib dosed at 300 mg twice daily significantly improved progression-free survival for patients with newly diagnosed BRCA1/2 mutated advanced ovarian cancer compared with placebo (HR, 0.30; 95% CI, 0.23 – 0.41; median not reached v 13.8 months).  The authors investigated PFS in SOLO1 for subgroups analysis based on preselected baseline factors.


Investigator-assessed PFS subgroup analyses of SOLO1 post platinum chemotherapy clinical response (CR or PR), surgery sub-type (upfront vs interval surgery), disease status post-surgery (residual or no gross residual disease), and BRCA1/2 mutation status. PFS in stage III disease patients who underwent upfront surgery and had no gross residual disease was also assessed. 


Olaparib versus placebo resulted in reduced risk of disease progression or death by 69% (HR, 0.31; 95% CI, 0.21 – 0.46) and 63% (HR, 0.37; 95% CI, 0.24 – 0.58) in patients undergoing upfront or interval surgery; 56% (HR, 0.44; 95% CI, 0.25 – 0.77) and 67% (HR, 0.33; 95% CI, 0.23 – 0.46) in patients with or without residual disease post-surgery; 66% (HR, 0.34; 95% CI, 0.24 – 0.47) and 69% in women with clinical CR or PR at baseline (HR, 0.31; 95% CI, 0.18 – 0.52); and 59% (HR, 0.41; 95% CI, 0.30 – 0.56) and 80% (HR 0.20; 95% CI, 0.10 to 0.37) in patients with a BRCA1/2 mutation, respectively.

The authors concluded “ Patients with newly diagnosed advanced ovarian cancer achieve substantial benefit from maintenance olaparib treatment regardless of baseline surgery outcome, response to chemotherapy, or BRCA mutation type.”


Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial