Ovarian cancer: upfront bevacizumab fails improve overall survival in phase 3

  • Tewari KS & al.
  • J Clin Oncol
  • 19 Jun 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The PFS benefit of add-on bevacizumab failed to translate to an OS advantage in patients with incompletely resected stage III-IV ovarian cancer receiving chemotherapy.
  • Adding concurrent+maintenance bevacizumab improved OS in stage IV, BRCA BRCA1/2 and non-BRCA1/2 homologous recombination repair (HRR)-mutated disease.

Why this matters

  • Bevacizumab was approved on the basis of PFS advantage; findings question clinical relevance of PFS.

Study design

  • Phase 3 GOG-0218 study of 1873 patients with incompletely resected stage III-IV ovarian cancer.
  • Patients were randomly assigned 1:1:1 to carboplatin+paclitaxel alone, or with concurrent bevacizumab or concurrent+maintenance bevacizumab.
  • Funding: National Cancer Institute; others.

Key results

  • Median follow-up was 102.9 months.
  • Compared with only chemotherapy (median OS, 41.1 months), median OS was not significantly different with addition of:
    • Concurrent+maintenance bevacizumab (median OS, 43.4 months; HR, 0.96; P=.53).
    • Concurrent bevacizumab (median OS, 40.8 months; HR, 1.06; P=.34).
  • Disease-specific survival was statistically similar between groups.
  • Exploratory analysis: concurrent+maintenance bevacizumab improved OS in:
    • Stage IV disease (42.8 v 32.6 months; HR, 0.75; 95% CI, 0.59 to 0.95).
    • BRCA1/2-mutated disease (HR, 0.62; 95% CI, 0.52-0.73).
    • Non-BRCA1/2 HRR-mutated disease (HR, 0.65; 95% CI, 0.51-0.85).
  • BRCA1/2 and HRR were not predictive of bevacizumab activity.

Limitations

  • Exploratory subset analysis.

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