Tykerb and Xeloda Seem to Shrink HER2-Positive Breast Cancer That’s Spread to Brain

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A very small, very early study offers some good news for women diagnosed with HER2-positive, metastatic breast cancer that has spread to the brain.

The combination of Tykerb (chemical name: lapatinib) and Xeloda (chemical name: capecitabine) seemed to shrink HER2-positive breast cancer lesions in the brain without radiation. The brain lesions hadn’t been treated before.

The study was published online by The Lancet Oncology on Nov. 2, 2012. Read the abstract of “Lapatinib plus capecitabine in patients with previously untreated brain metastases from HER2-positive metastatic breast cancer (LANDSCAPE): a single-group phase 2 study.”

Of the 44 women in the study, about 66% (29 women) had brain lesions that shrank by 50% or more after the combination of Tykerb and Xeloda. Many of the women were able to delay whole-brain radiation for more than 8 months.

In most cases, women diagnosed with HER-positive, metastatic breast cancer that has spread to the brain are treated with whole-brain radiation, which can cause problems with thinking and memory. Being able to delay whole-brain radiation could be a big advance in treatment for these women.

Like Herceptin (chemical name: trastuzumab), Tykerb is a targeted therapy that works against breast cancers that are HER2-positive. This means they make too much of the HER2/neu protein. While Herceptin blocks the protein on the cancer cells’ surface, Tykerb blocks the protein inside the cell. Because it uses a different mechanism to work, Tykerb may be effective against HER2-positive cancers that have stopped responding to Herceptin. Tykerb is a pill taken by mouth.

Xeloda is a chemotherapy medicine that interferes with cancer cells’ ability to divide. Xeloda also is a pill taken by mouth.

Tykerb is approved by the U.S. Food and Drug Administration (FDA) to be given in combination with Xeloda to treat advanced-stage, HER2-positive breast cancer that has stopped responding to anthracyclines, taxanes, and Herceptin.

While the results of this study are promising, it’s important to know that the combination of Tykerb and Xeloda caused some serious side effects. Nearly 50% of the women had severe side effects. The most common were:

  • diarrhea (9 women)
  • hand-foot syndrome (9 women)

Four women had to stop treatment because the side effects were so severe.

It’s also important to know that this study was a phase II trial, which means it was looking at how effective a new treatment is. Phase II trials are usually small and the results are considered early results. If the results are promising, the new treatment will probably go on to a phase III trial. Phase III trials are usually large and are the last step a new treatment goes through before the FDA considers approving it for general use.

If you’ve been diagnosed with HER2-positive, metastatic breast cancer that has spread to the brain, you and your doctor may be considering a number of treatment options. If you’re willing to participate in a clinical trial, you may have even more options available, possibly including an experimental combination such as Tykerb and Xeloda to treat brain metastases. Talk to your doctor about clinical trials that might be a good fit for you and your unique situation. Visit the Breastcancer.org Clinical Trials pages for more information.

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