Friday, December 17, 2010

Avastin and TNBC: Let's Refocus the Research

Recent research has shown that Avastin can be effective against triple-negative when paired with standard chemo; when used with the chemo drug Xeloda; and when paired with taxanes. It has shown special promise for metastatic triple-negative. As a targeted therapy, it offers a way of treating cancer that goes beyond typical chemo. Still, the drug's effects are usually limited to triple-negative, extending patients lives by several months. And the numbers are small, because the percentage of women with triple-negative in any study of overall breast cancer tends to be fewer than 20 percent, usually between 15 percent and 18 percent.

Yesterday the FDA said the evidence of the drug's effectiveness in treating breast cancer was weak and it began the process of pulling its approval for use of Avastin in breast cancer. The cost, they say—some $8,000 a treatment—outweighs the benefits. It is still allowed for other forms of cancer, such as brain, colon, kidney, and lung.

Once again, the experts lump all breast cancers together. The drug was not effective for hormone-positive, so its use is pulled for all breast cancer. I hope this does not stop research on Avastin and other biologic agents, which may ultimately be the future of triple-negative treatment.

The side-effects of Avastin can be significant, including high blood pressure and internal bleeding. And its benefits are usually limited to an average of a few months. Plus, there is some indication that keeping women on the drug too long can actually cause a recurrence. So much remains to be learned about the drug.

Yet, there are plenty of stories of women who have done extremely well on Avastin. Josh Turnage of Mississippi wrote eloquently about how the drug saved his mother. And Stacey Singer, writing in Palm Beach Post Health offers another excellent patient story plus a good perspective on why some doctors and patient advocates think the FDA made the wrong move.

More research is needed specifically on Avastin and triple-negative. This requires a change in focus, but that focus might ultimately yield enough evidence to demonstrate the drug's effectiveness--or lack thereof--for this important and specific subgroup.

Rather than triple-negative being an add-on, it should be the focus of research on Avastin.

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