Theme

Maintenance Olaparib Reduces Risk of Progression or Death by 70% in Newly Diagnosed, BRCA-Mutated Advanced Ovarian Cancer

Source
Source: Moore K, Colombo N, Scambia G, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018;379:2495-2504. (SOLO1 ClinicalTrials.gov number, NCT01844986).
SOLO1 Phase 3 Trial N=391 41-Month Median Follow-up
Hazard Ratio
0.30
70% Risk Reduction
Disease Progression or Death
(P<0.001)

Study Design

  • Population: Newly diagnosed, advanced (FIGO III/IV) ovarian cancer w/ BRCA1/2 mutation.
  • Comparison (2:1):
    • Olaparib: 300 mg BID (n=260)
    • Placebo: (n=131)
  • Duration: Until progression or 2 years.

Safety Signal

Grade 3/4 Anemia

12% discontinuation rate in Olaparib arm due to adverse events.

Median Progression-Free Survival (PFS)

*Median not reached for Olaparib in primary analysis; ~36 months est. via sensitivity analysis.

3-Year Sustained Remission Rates

Percentage of patients free from disease progression and death at 36 months.

Clinical Recommendation: Standard of Care

Adopt Olaparib maintenance therapy for newly diagnosed, advanced ovarian cancer (BRCA1/2m). Immediate maintenance following first-line chemotherapy offers a potentially curative shift—sustaining long-term progression-free survival.

Monitor: Watch closely for hematologic toxicity, specifically anemia.
AbbreviationsQuick
CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; NC, not calculated; PARP, poly(adenosine diphosphate–ribose) polymerase; RECIST, Response Evaluation Criteria in Solid Tumors; ULN, upper limit of the normal range.
Bibliography8
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