Communities Breast Imaging Bevacizumab improves outcome in newly diagnosed advanced breast cancer
Bevacizumab improves outcome in newly diagnosed advanced breast cancer
Tuesday, 30 November 1999 00:00 | 
| Communities |
Results of a phase III, double-blind, placebo-controlled trial confirm the clinical benefit of combining first-line bevacizumab (Avastin) with taxane chemotherapy for patients with HER2-negative metastatic breast cancer.
The results were presented Saturday at the annual meeting of the American Society of Clinical Oncology by Dr. David Miles of the Mount Vernon Cancer Centre in London, UK.
In the study, a total of 736 women with previously untreated locally recurrent or metastatic breast cancer were randomized to first-line therapy with docetaxel plus either placebo or bevacizumab (7.5 or 15 mg/kg every three weeks).
"Importantly, as we started this study, data had recently become available suggesting a benefit to bevacizumab, so we felt it important that upon disease progression all patients had the option to receive bevacizumab in the second-line setting with their chemotherapy," Dr. Miles noted.
After a median follow-up of 11 months, progression-free survival - the primary endpoint - was significantly superior in both bevacizumab arms compared with docetaxel alone.
In the unstratified analysis, women in the lower-dose bevacizumab arm were 21 per cent less likely to experience disease progression compared with women in the placebo arm. That is, the hazard ratio was 0.79, which was significant with a p value of 0.03, Dr. Miles noted. The higher-dose of bevacizumab produced a "slightly better" effect, with a hazard ratio of 0.72 (p = 0.0099).
In the pre-specified stratified analysis with censoring for additional anti-neoplastic therapy that started prior to disease progression, the hazard ratios for progression in the lower- and higher-dose bevacizumab arms were 0.69 and 0.61, respectively.
Tumor shrinkage was seen in 44.4 per cent of women in the placebo plus docetaxel arm, compared with 55.2 per cent and 63.1 per cent of women in the lower-dose and higher-dose bevacizumab arms, respectively.
Dr. Miles said the survival data are not yet mature and will be presented at a later date.
The rate of grade three or higher adverse events was slightly higher in the two bevacizumab arms: 74.8 per cent in the lower dose arm and 74.1 per cent in the higher dose arm, compared with 67.0 per cent in the docetaxel-placebo arm. "But I think the very important point is that, when we look at adverse events leading to death of patients, then the figures are really very comparable in each arm," Dr. Miles said.
"What I'm most reassured about from this trial," he added, "is the absence of new safety signals and the fact that some of the toxicities that we may have had concerns about in the past - for example, bowel perforation and thrombotic events - are really not at all worrisome and very equal across the three treatment arms."
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