- 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.
- 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.
- 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.
- Exploratory subset analysis.