OlympiAD
Trial question
What is the role of olaparib monotherapy in patients with HER2- metastatic breast cancer and germline BRCA mutations?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
98.0% female
2.0% male
N = 302
302 patients (295 female, 7 male).
Inclusion criteria: patients with HER2- metastatic breast cancer and germline BRCA mutations.
Key exclusion criteria: HER2+ disease; prior treatment with PARP inhibitor; > 2 prior lines of chemotherapy for metastatic breast cancer; untreated and/or uncontrolled brain metastases; HIV infection; pregnancy or lactation.
Interventions
N=205 olaparib monotherapy (at a dose of 300 mg BID).
N=97 standard therapy (capecitabine, eribulin, or vinorelbine in 21-day cycles, based on the physician's choice).
Primary outcome
Median progression-free survival
7 months
4.2 months
7.0 months
5.3 months
3.5 months
1.8 months
0.0 months
Olaparib
monotherapy
Standard
therapy
Significant
increase ▲
Significant increase in median progression-free survival (7 months vs. 4.2 months; HR 1.72, 95% CI 1.25 to 2.33).
Secondary outcomes
Significantly greater improvement in mean 30-Item European Organization for Research and Treatment of Cancer QoL Questionnaire (3.9 points vs. -3.6 points; MD 7.5, 95% CI 2.5 to 12.4).
Safety outcomes
No significant difference in adverse event.
Conclusion
In patients with HER2- metastatic breast cancer and germline BRCA mutations, olaparib monotherapy was superior to standard therapy with respect to median progression-free survival.
Reference
Mark Robson, Seock-Ah Im, Elżbieta Senkus et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533.
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