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First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial. | LitMetric

AI Article Synopsis

  • This study evaluated the effectiveness and safety of combining bevacizumab with carboplatin and paclitaxel (CP) as a first-line treatment for stage III/IV ovarian cancer in Chinese patients after surgery.
  • Results showed that patients receiving bevacizumab + CP had a median progression-free survival (PFS) of 22.6 months, significantly longer than the 12.3 months for those on placebo + CP.
  • The safety profile indicated that treatment-related severe side effects were more common in the bevacizumab group (94%) compared to the placebo group (68%), but the drug's overall safety was consistent with previous findings.

Article Abstract

Objective: First-line bevacizumab plus carboplatin and paclitaxel (CP) is approved for stage III/IV ovarian cancer treatment following initial surgical resection, based on global phase III GOG-0218 and ICON7 trials. This study evaluated the efficacy and safety of bevacizumab + CP as first-line ovarian cancer therapy in Chinese patients.

Methods: Patients with newly diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer post-primary surgery were randomized 1:1 to receive 6 cycles of CP with bevacizumab/placebo, followed by bevacizumab/placebo maintenance until unacceptable toxicity or disease progression. Primary endpoint was investigator-assessed progression-free survival (PFS). Stratification factors were FIGO stage and debulking status (stage III optimally debulked vs stage III suboptimally debulked vs stage IV) and Eastern Cooperative Oncology Group performance status (0 vs 1 or 2).

Results: Of randomized patients, 51 received bevacizumab + CP and 49 received placebo + CP. Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP (stratified hazard ratio=0.30; 95% CI=0.17, 0.53). Treatment-related grade 3/4 adverse events occurred in 46 of 49 (94%) patients receiving bevacizumab + CP, and 34 of 50 (68%) receiving placebo + CP.

Conclusion: Bevacizumab + CP showed clinically meaningful improvement in PFS vs placebo + CP, consistent with GOG-0218 results. Safety data were aligned with the known bevacizumab safety profile. These results support first-line bevacizumab + CP therapy in Chinese patients with ovarian cancer.

Trial Registration: ClinicalTrials.gov Identifier: NCT03635489.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11390243PMC
http://dx.doi.org/10.3802/jgo.2024.35.e99DOI Listing

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