Recurrent ovarian cancer: secondary surgery fails phase 3

  • Coleman RL & al.
  • N Engl J Med
  • 14 Nov 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with platinum-sensitive recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy is feasible but does not extend survival vs chemotherapy alone.

Why this matters

  • Secondary cytoreduction is widely performed, but there is limited supporting literature.

Study design

  • Phase 3, multicenter, GOG-0213 study of 485 platinum-sensitive patients with recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Patients were randomly assigned 1:1 to either undergo secondary surgical cytoreduction followed by platinum-based chemotherapy or platinum-based chemotherapy alone.
  • Funding: National Cancer Institute.

Key results

  • Median follow-up was 48.1 months.
  • 67% of the patients who underwent surgery achieved complete gross resection.
  • 84% of patients received concomitant and maintenance bevacizumab.
  • No difference was observed in the surgery vs no-surgery group in:
    • OS (median, 50.6 vs 64.7 months; HR, 1.29; P=.08); adjustment for chemotherapy regimen used, platinum-free interval, or previous bevacizumab use did not modify the OS.
    • PFS (median, 18.9 vs 16.2 months; HR, 0.82; 95% CI, 0.66-1.01).
  • Surgical morbidity was 9% at 30 days and 0.4% of patients died from postoperative complications.
  • Patients undergoing surgery reported a significant decline immediately after secondary cytoreduction.
  • QoL did not differ between groups at 6 and 15 weeks and at 6- and 12-month follow-ups.

Limitations

  • Open-label design.

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