Avastin Combined with Taxol Slows Advanced Breast Cancer

Reviewed study: "Avastin Combined with Taxol Slows Advanced Breast Cancer" by K.D. Miller et al., American Society of Clinical Oncology Annual Meeting, May 2005, late-breaking session

Is this for me? If you have advanced (metastatic) breast cancer and have not yet had chemotherapy for your advanced disease, you might want to read this article. (If you had chemotherapy for early-stage disease and now have advanced breast cancer, then this article is for you too.)

Background and importance of the study: Drugs that choke off the blood supply to cancer cells improve survival in people with advanced colon and lung cancers. These are known as antiangiogenesis drugs. Anti means "in opposition to," angio means "blood vessel," and genesis means "beginning."

Researchers wondered if antiangiogenesis drugs would also benefit women with advanced breast cancer. Advanced breast cancer is cancer that has spread from the breast to another part of the body.

Avastin (chemical name: bevacizumab) is an antiangiogenesis drug that has been approved by the U.S. Food and Drug Administration (FDA) to treat advanced colorectal cancer when combined with chemotherapy.

The study reviewed here compared two treatment plans in women with advanced breast cancer:

• Avastin plus Taxol (chemical name: paclitaxel), and
• Taxol alone

The researchers wanted to see if Avastin plus Taxol would slow the progression of the cancer more than Taxol alone.

The study was sponsored by the National Cancer Institute and carried out by researchers of the Eastern Cooperative Oncology Group (ECOG). The study also was funded by The Breast Cancer Research Foundation. The study is known as trial E2100.

Study design: Done between December 2001 and May 2004, the study included 722 women with advanced breast cancer who HAD NOT previously received chemotherapy treatment for their advanced cancer. (Women could have received chemotherapy in the past for early-stage disease, after their surgery.) Women with HER2-positive breast cancer were not included in the study unless they had already taken Herceptin or were unable to take Herceptin. Women who had a history of blood clots or who were taking blood-thinning medication also were not included.

The women were randomly assigned to receive Avastin plus Taxol or only Taxol. The researchers followed the women's progress for at least one year. They looked at the possible benefits of adding Avastin to Taxol, as well as any differences in side effects between the two treatment groups.

Study results: The researchers have finished their first analysis of the results. Women who received Avastin plus Taxol had a longer time before their cancer worsened (an average of 11 months) than women who got only Taxol (an average of 6 months). In other words, compared to Taxol alone, Avastin plus Taxol provided a 50% reduction in the risk of the cancer worsening. The reduction is statistically significant. This means that the longer time before the cancer progressed is probably due to adding Avastin to Taxol, and not just to chance.

Avastin plus Taxol also reduced the risk of death by 33% compared to Taxol alone. More information about survival will be available in the future.

In women whose metastatic disease could be measured, such as those who had a lung nodule, Avastin plus Taxol reduced the size of the cancer by 28%, while Taxol alone reduced the cancer only by 14%. So Avastin plus Taxol doubled the amount of the shrinkage of cancer compared to Taxol alone.

Based on these early results, the committee overseeing the study recommended that the results be shared with the public. This is the first time a drug that chokes off the blood supply to cancer cells has been shown to benefit women with breast cancer.

The women who received Avastin plus Taxol did have had more side effects than women who received Taxol alone:

• neuropathy (nerve pain in hands and legs): 21% vs. 14%;
• high blood pressure: 13% vs. 0%; and
• proteinuria (too much protein in the urine): 2% vs. 0%.

Conclusions: The researchers concluded that Avastin combined with Taxol slows the progression of advanced breast cancer better than Taxol alone.

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