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Docetaxel plus bevacizumab improves PFS in breast cancer
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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.