BRCA+ ovarian cancer: maintenance olaparib boosts PFS in SOLO1

  • Moore K & al.
  • N Engl J Med
  • 21 Oct 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In women with BRCA+, platinum-sensitive advanced ovarian cancer, olaparib maintenance therapy lowered the risk for disease progression or death by 70% vs placebo.

Why this matters

  • Nearly 70% of patients relapse within 3 years of initial treatment; maintenance olaparib can become standard treatment in this setting.

Study design

  • Randomized, double-blind, phase 3 SOLO1 study of 391 BRCA1/2-mutated patients with newly diagnosed advanced high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer who received cytoreductive surgery and platinum-based chemotherapy. 
  • 260 patients were assigned to maintenance olaparib, and 131 to placebo.
  • Primary endpoint: PFS (time to disease progression or death).
  • Funding: AstraZeneca; MSD.

Key results

  • Median follow-up was 41 months.
  • 3-year PFS rate was significantly higher in patients who received olaparib vs placebo (60% vs 27%; HR, 0.30; P<.001>
  • Time to first subsequent therapy or death was significantly longer with olaparib vs placebo (median, 51.8 vs 15.1 months; HR, 0.30; 95% CI, 0.22-0.40).
  • 21% of the patients in the olaparib group experienced serious adverse events vs 12% in the placebo group.
  • Anemia was the most common serious adverse event with olaparib.
  • Health-related QoL did not change significantly in both groups.

Limitations

  • OS data were immature.

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