A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Trial ID # NCT01462890; AGO-OVAR17
Phase III
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Bevacizumab, Carboplatin, Paclitaxel
Eligible Participant

Newly diagnosed stage IIb-IV ovarian cancer

Patients Enrolled

927

Therapy Setting

First-line

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac+Bev (15 months, n=464) vs CarboPt+Pac+Bev (30 months, n=463):

PFS: 24.2 vs 26.0 months, HR: 0.99 (0.85-1.15, p=0.90)
OS: 54.3 vs 60.0 months, HR: 1.04 (0.87-1.23, p=0.68)

Clinically Significant Adverse Events

Serious AE: overall (11 vs 14%)
Grade 3-4 AE:

Conclusion

Longer treatment with bevacizumab for up to 30 months improves neither PFS nor OS in patients with newly diagnosed ovarian cancer. Therefore bevacizumab treatment duration of 15 months remains standard of care

Reference

Pfisterer J et al. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol (2023) 41(4):893-902
https://pubmed.ncbi.nlm.nih.gov/36332161/

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