An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial-

Trial ID # UMIN000017247; JGOG3023
Phase II
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 Liposomal doxorubicin, Paclitaxel, Topotecan, Bevacizumab, Gemcitabine
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

103; median 2 prior therapies (estimated from publication data)

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST or CA125

Efficacy

Treatment of Physician's Choice (TPC) of non-platinum chemotherapy: Gem (n=19)/Pac (n=8)/PLD (n=21)/Top (n=4)+Bev vs TPC Gem (n=18)/Pac (n=8)/PLD (n=21)/Top (n=4):

ORR (RECIST): 25.0 (1CR, 12PR) vs 13.7% (7PR), p=0.0599
ORR (GCIG CA125):  21.4 vs 16.7%
PFS: 4.0 vs 3.1 months, HR: 0.54 (0.30-0.92, p=0.0082)
OS: 15.3 vs 11.3 months, HR: 0.67 (0.38-1.17, p=0.1556)

Clinically Significant Adverse Events

TPC+Bev vs TPC:
Serious AE: overall (15.7 vs 6.0%), 1 death - infection in PLD+Bev arm
Grade 3-4 AE: overall (54.9 vs 42.0%), neutropenia (37.3 vs 32.0%), thrombocytopenia (9.8 vs 14.0%)

Conclusion

Retreatment with bevacizumab is effective and AEs are manageable for platinum resistant recurrent ovarian cancer previously treated with bevacizumab for front-line or platinum sensitive recurrence

Reference

Shoji T et al. Efficacy and safety of standard of care with/without bevacizumab for platinum-resistant ovarian/fallopian tube/peritoneal cancer previously treated with bevacizumab: The Japanese Gynecologic Oncology Group study JGOG3023. Cancer Sci (2022) 113(1):240-250
https://pubmed.ncbi.nlm.nih.gov/34716979/

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