Study Finds Apparent Benefit of Adding Fosbretabulin to Bevacizumab in Recurrent Ovarian, Tubal, or Peritoneal Carcinoma
Adding the vascular-disrupting agent fosbretabulin to bevacizumab (Avastin) improved outcomes in patients with recurrent ovarian, tubal, or peritoneal carcinoma, according to a randomized phase II NRG Oncology/Gynecologic Oncology Group study reported in the Journal of Clinical Oncology by Monk et al. Fosbretabulin is reported to selectively target the preexisting tumor vasculature, leading to vascular shutdown and cancer cell death and necrosis.
Study Details
In the study, 107 patients who had received no more than three prior regimens were randomized to receive bevacizumab at 15 mg/kg once every 3 weeks (n = 53) or bevacizumab plus intravenous fosbretabulin at 60 mg/m2 once every 3 weeks (n = 54). The primary endpoint was progression-free survival.
Outcomes
Median progression-free survival was 4.8 months in the bevacizumab group vs 7.3 months in the combination group (hazard ratio = 0.69, P = .05). Response was observed in 28.2% vs 35.7% among the 39 bevacizumab patients and 42 combination patients with measurable disease.
Toxicity
Adverse events greater than grade 3 were more common in the combination regimen than in the bevacizumab regimen only for hypertension (35% v 20%). A grade 3 thromboembolic event occurred in one patient in the combination group, and intestinal fistula occurred in one patient in the bevacizumab group. No treatment-related deaths were reported.
The investigators concluded: “On the basis of the [progression-free survival], overall response rate, and tolerability of these two antivascular therapies, further evaluation is warranted for this chemotherapy-free regimen.”
The study was supported by grants from the National Cancer Institute.
Bradley J. Monk, MD, of Creighton University School of Medicine, Omaha, Nebraska, is the corresponding author of the Journal of Clinical Oncology article.
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