Background: The study was undertaken to determine the safety and efficacy of the monoclonal, antivascular endothelial growth factor antibody bevacizumab in combination with cytotoxic chemotherapy for women with platinum-refractory ovarian cancer.
Methods: A retrospective analysis of women who received bevacizumab in combination with a cytotoxic agent was performed. Response was determined by measurable disease or assessment of serial cancer antigen (CA) 125 measurements.
Results: Twenty-three patients were identified. The patients were heavily pretreated with a median of 7 prior regimens including a median of 3 prior platinum regimens. The combination regimen included cyclophosphamide in 15 (65%), 5-fluorouracil (5-FU) in 6 (26%), docetaxel in 1 (4%), and gemcitibine/liposomal doxorubicin in 1 (4%). Two (9%) women developed chylous ascites during treatment. CTC Grade 4-5 toxicities occurred in 4 (17%) subjects. Gastrointestinal perforation occurred in 2 (9%) patients. Measurable disease was present in 22. The overall best response rate was 35% and all 8 were partial responses (PRs). Stable disease was found in a further 10 (44%) women, whereas progressive disease was observed in 5 (22%). The median time to progression was 5.6 months in patients with a PR and 2.3 months in subjects with stable disease. Three (13%) women experienced a progression-free interval (PFI) of >6 months. At last follow-up, 8 (35%) subjects had died of disease, whereas 15 (65%) women were alive with disease.
Conclusions: Combination bevacizumab therapy demonstrated activity in heavily pretreated women with ovarian cancer. Gastrointestinal perforations were identified in 9%. Despite the toxicity of the regimen, prospective studies, particularly in less heavily pretreated patients, are warranted.
Copyright 2006 American Cancer Society.