Relapsed ovarian cancer: olaparib tops chemotherapy in platinum-sensitive BRCA+ patients

  • Penson RT & al.
  • J Clin Oncol
  • 19 Feb 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Olaparib resulted in superior objective response rate (ORR) and PFS vs nonplatinum chemotherapy in heavily pretreated patients with platinum-sensitive ovarian cancer harboring germline BRCA mutation.

Why this matters

  • Relapsed ovarian cancer has a poor prognosis.

Study design

  • Randomized, multinational, phase 3 SOLO3 trial of 223 patients with platinum-sensitive relapsed ovarian cancer and a germline BRCA1/2 mutation, randomly assigned to olaparib (n=151) or nonplatinum chemotherapy (n=72).
  • Primary outcome: ORR assessed by blinded independent central review (BICR).
  • Funding: AstraZeneca.

Key results

  • ORR was significantly higher with olaparib vs chemotherapy:
    • 72.2% vs 51.4%;
    • OR, 2.53 (P=.002).
  • In post hoc subgroup analysis, olaparib was linked to significantly improved ORR in patients who had received 2 prior lines of treatment:
    • 84.6% vs 61.5%;
    • OR, 3.44 (95% CI, 1.42-8.54).
  • Olaparib was also linked to significantly improved BICR-assessed PFS:
    • Median, 13.4 vs 9.2 months;
    • HR, 0.62 (P=.013).
  • The most common grade ≥3 adverse events were anemia in the olaparib group and palmar-plantar erythrodysesthesia and neutropenia in the chemotherapy group.
  • Serious adverse event rate was 23.6% in the olaparib group vs 18.4% in the chemotherapy group.
  • 2.2% of patients in the olaparib and 3.9% in the chemotherapy group developed myelodysplastic syndrome/acute myeloid leukemia.

Limitations

  • Open-label study.