Wednesday, December 21, 2011 (Last Updated: 12/22/2011)WEDNESDAY, Dec. 21 (HealthDay News) -- Aflibercept, a potent inhibitor of vascular endothelial growth factor (VEGF), shows clinical activity and increases the time to repeat paracentesis for patients with advanced chemo-resistant ovarian cancer and recurrent symptomatic malignant ascites, according to a study published online Dec. 21 in The Lancet Oncology.
Walter H. Gotlieb, M.D., from McGill University in Montreal, and colleagues assessed the safety and efficacy of aflibercept in the treatment of malignant ascites. In a phase 2 study, 55 patients with advanced chemo-resistant ovarian cancer and recurrent symptomatic malignant ascites were stratified by the time interval between the two most recent paracenteses. Following stratification, participants were randomized to receive either intravenous aflibercept (4 mg/kg every two weeks; 26 patients) or placebo (29 patients). The double-blind phase of the study continued until repeat paracentesis, or for a minimum of 60 days, following which the participants could opt for aflibercept treatment. The time to repeat paracentesis during the double-blind phase was the primary efficacy end point.
The investigators found that the aflibercept group had a significantly longer mean time to repeat paracentesis than the placebo group (55.1 versus 23.3 days). Two patients from the aflibercept group did not require a repeat paracentesis during the six months of double-blind treatment. Dyspnea, fatigue or asthenia, and dehydration were the most common grade 3 or 4 treatment-emergent adverse events. The aflibercept group had a higher frequency of fatal gastrointestinal events (three intestinal perforations) than the placebo group (one intestinal fistula leading to sepsis).
"This study shows the effectiveness of VEGF blockade in the reduction of malignant ascites," the authors write.
Several authors disclosed financial relationship with pharmaceutical companies, including Sanofi-Aventis, whose Sanofi Oncology division funded the study.
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