Prolonging the duration of frontline treatment with bevacizumab does not improve outcomes in patients with ovarian cancer, according to research published in the Journal of Clinical Oncology.
The phase 3 trial showed that 30 months of bevacizumab treatment did not improve progression-free survival (PFS) or overall survival (OS) when compared with the standard 15 months.
The trial (ClinicalTrials.gov Identifier: NCT01462890) included 927 patients with newly diagnosed, stage IIB-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. All patients underwent primary cytoreductive surgery and received 6 cycles of chemotherapy (paclitaxel plus carboplatin every 3 weeks).
The patients were randomly assigned to receive bevacizumab at 15 mg/kg every 3 weeks for 22 cycles (n=464) or for 44 cycles (n=463), corresponding with 15 months or 30 months of treatment, respectively.
At baseline, the median age was 61 (range, 25-86) years in the 15-month cohort and 60 (range, 21-89) years in the 30-month cohort. Most patients (84% in both arms) had ovarian cancer, stage IIIC disease (61% and 64%, respectively), and high-grade serous disease (78% and 79%, respectively).
The study’s primary endpoint was PFS. The median PFS was 24.2 months in the 15-month cohort and 26.0 months in the 30-month cohort (hazard ratio [HR], 0.99; 95% CI, 0.85-1.15; P =.90).
The median OS was 54.3 months in the 15-month cohort and 60.0 months in the 30-month cohort (HR, 1.04; 95% CI, 0.87-1.23; P =.68).
In subgroup analyses, neither treatment strategy was favored over the other for PFS or OS in any prespecified subgroup.
“Longer treatment duration with bevacizumab for up to 30 months did not improve PFS or OS in patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer,” the researchers concluded. “A bevacizumab treatment duration of 15 months remains the standard of care.”
The proportion of patients who experienced 1 or more adverse events was 99% in both treatment groups. The most common grade 3 or higher adverse events of special interest (in the 15-month and 30-month cohorts, respectively) were hypertension (20% vs 25%), thromboembolic events (4% vs 3%), and proteinuria (2% vs 4%).
Disclosures: Financial support and the bevacizumab used in this trial were provided by F. Hoffmann-La Roche Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Pfisterer J, Joly F, Kristensen G, 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. Published online November 4, 2022. doi:10.1200/JCO.22.01010