CHICAGO — Adding bevacizumab to docetaxel slowed progression of
locally advanced or metastatic breast cancer in patients who had not received
prior treatment, according to results of the AVADO trial.
The results of AVADO, an international, randomized, double blind phase-3
trial, were presented at the 2008 ASCO Annual Meeting by David Miles, MD, a
professor at the Mount Vernon Cancer Centre in London. Bevacizumab (Avastin,
Genentech) with paclitaxel was approved by the FDA in February to treat
newly-diagnosed metastatic breast cancer, based on studies with
progression-free survival as the primary endpoint .
“Patients who received the higher bevacizumab dose had a response
rate of 63%, whereas patients who received the lower dose had a 55% response
rate,” Miles said at a press briefing. “In terms of the hazard ratios
for progression and the response rates, it appears that the higher dose is a
better option for our patients.
From March 2006 to April 2007, 736 patients enrolled onto the AVADO
trial were randomly assigned to one of three arms: docetaxel plus placebo,
docetaxel plus 15 mg/kg bevacizumab, or docetaxel plus 7.5 mg/kg bevacizumab.
Docetaxel was administered every three weeks for up to nine cycles. Bevacizumab
was administered every three weeks until disease progression or unacceptable
toxicity.
After a median follow-up of 11 months, progression-free survival was
better for both groups who received bevacizumab compared to docetaxel alone. In
an unstratified analysis, the hazard ratios were 0.79 in the group that
received 7.5 mg/kg bevacizumab and 0.72 in the group that received 15 mg/kg
bevacizumab. In a stratified analysis, the hazard ratios were 0.69 for the 7.5
mg/kg bevacizumab group and 0.61 for the 15 mg/kg bevacizumab group.
The adverse events were similar between the two bevacizumab groups, and
there were no unexpected toxicities, Miles said.
Miles D, Chan A, Romieu G, et al. #LBA1011. Presented at: 2008 ASCO
Annual Meeting. May 30 – June 3. Chicago.