In a European phase III trial (AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15) reported in the Journal of Clinical Oncology, Jacobus Pfisterer, MD, PhD, and colleagues found no significant progression-free survival benefit with the extension of bevacizumab treatment from 15 to 30 months in patients receiving front-line treatment for stage IIB to IV ovarian cancer.
Longer treatment duration with bevacizumab for up to 30 months did not improve progression-free survival or overall survival in patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer. A bevacizumab treatment duration of 15 months remains the standard of care.— Jacobus Pfisterer, MD, PhD, and colleagues
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Study Details
The open-label multicenter trial included 927 women with primary epithelial ovarian, fallopian tube, or peritoneal cancer enrolled between November 2011 and August 2013. Patients underwent primary cytoreductive surgery followed by six cycles of chemotherapy with paclitaxel at 175 mg/m2 plus carboplatin at AUC 5 once every 3 weeks plus bevacizumab at 15 mg/kg once every 3 weeks. Patients were randomly assigned to receive bevacizumab for 15 months (22 cycles; standard group, n = 464) or 30 months (44 cycles; extended group, n = 463) with stratification according to International Federation of Gynecology and Obstetrics stage/residual tumor. The primary endpoint was investigator-assessed progression-free survival.
Progression-Free Survival
At data cutoff for the final analysis (in January 2021), median follow-up was 85 months (95% confidence interval [CI] = 82–86 months). Median progression-free survival was 24.2 months (95% CI = 22.2–26.5 months) in the standard group vs 26.0 months (95% CI = 23.7–29.7 months) in the extended group (hazard ratio [HR] = 0.99, 95% CI = 0.85–1.15, P = .90). Restricted mean survival time analysis showed a mean progression-free survival of 39.5 vs 39.3 months (P = .92).
Median overall survival was 54.3 months (95% CI = 51.0–64.6 months) in the standard group vs 60.0 months (95% CI = 54.0–68.6 months) in the extended group (HR = 1.04, 95% CI = 0.87–1.23, P = .68). Restricted mean survival time analysis showed a mean overall survival of 60.4 vs 60.8 months (P = .87).
KEY POINTS
- 30 vs 15 months of bevacizumab did not significantly improve progression-free or overall survival.
- Median progression-free survival was 26.0 vs 24.2 months.
Adverse Events
Grade ≥ 3 adverse events over the entire treatment course occurred in 63% of patients in the standard group vs 68% of patients in the extended group. Adverse events of special interest occurred in 29% vs 34% of patients. The extended-bevacizumab group had somewhat higher incidence of grade ≥ 3 hypertension (25%, with 4% during the additional cycles, vs 20% in the standard group) and grade ≥ 3 proteinuria (4%, with 2% during additional cycles, vs 2% in the standard group), with no other notable differences observed between groups. Intestinal perforation occurred in four patients in the standard group vs seven patients in the extended group.
The investigators concluded, “Longer treatment duration with bevacizumab for up to 30 months did not improve progression-free survival or overall survival in patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer. A bevacizumab treatment duration of 15 months remains the standard of care.”
Dr. Pfisterer, of AGO Study Group and Gynecologic Oncology Center, Kiel, Germany, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by F. Hoffmann-La Roche Ltd. For full disclosures of the study authors, visit ascopubs.org.
