Dr. Tripathy on the AVEREL Bevacizumab Trial Results

Debu Tripathy, MD
Published: Friday, Dec 09, 2011

Debu Tripathy, MD, professor of medicine and co-leader of the Women’s Cancer Program at the University of Southern California Norris Comprehensive Cancer Center, discusses the results of the AVEREL trial, the first phase III trial looking at bevacizumab (Avastin) in combination with trastuzumab (Herceptin) and docetaxel for patients with HER2-positive metastatic breast cancer.

The AVEREL results suggested a delay in progression with the addition of bevacizumab. The investigator-assessed median progression-free survival (PFS) was 18% (HR=0.82; P= .0775), which translated to 2.8 months and was deemed not significant. A separate analysis by an independent review committee determined the addition of bevacizumab increased the median PFS by 28% (HR=0.72; P=.0162), this analysis was deemed significant.

Tripathy notes the implications of the AVEREL trial are not clear at this point and it remains indefinite whether or not it will impact how physicians practice or how the regulatory agencies will look at bevacizumab.

One of the key issues surrounding the use of bevacizumab for patients with breast cancer has been the benefit compared to the potential toxicity and side effects. Despite being outweighed by the lives saved bevacizumab has shown a small increase in treatment related deaths. These issues warrant a closer look, specifically when a survival benefit is not found to be statistically significant.


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Debu Tripathy, MD, professor of medicine and co-leader of the Women’s Cancer Program at the University of Southern California Norris Comprehensive Cancer Center, discusses the results of the AVEREL trial, the first phase III trial looking at bevacizumab (Avastin) in combination with trastuzumab (Herceptin) and docetaxel for patients with HER2-positive metastatic breast cancer.

The AVEREL results suggested a delay in progression with the addition of bevacizumab. The investigator-assessed median progression-free survival (PFS) was 18% (HR=0.82; P= .0775), which translated to 2.8 months and was deemed not significant. A separate analysis by an independent review committee determined the addition of bevacizumab increased the median PFS by 28% (HR=0.72; P=.0162), this analysis was deemed significant.

Tripathy notes the implications of the AVEREL trial are not clear at this point and it remains indefinite whether or not it will impact how physicians practice or how the regulatory agencies will look at bevacizumab.

One of the key issues surrounding the use of bevacizumab for patients with breast cancer has been the benefit compared to the potential toxicity and side effects. Despite being outweighed by the lives saved bevacizumab has shown a small increase in treatment related deaths. These issues warrant a closer look, specifically when a survival benefit is not found to be statistically significant.


>>>Return to the main conference coverage page.

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