LONDON (Reuters) - A combination drug treatment that includes Tykerb, know generically as lapatinib, appears to be able to fight breast cancer that has spread to the brain, GlaxoSmithKline Plc announced Sunday.
An extension to an earlier phase II study involving 49 patients showed 20 percent of those receiving Tykerb and Xeloda experienced at least a 50 percent volume reduction in measurable brain metastases, cancer that has spread from its site of origin.
The finding is significant because up to one third of women with HER2-positive advanced breast cancer may develop brain metastases.
The results were presented at the San Antonio Breast Cancer Symposium in San Antonio, Texas.
Tykerb, a once-daily pill, was approved by U.S. regulators in March and won a conditional green light from the European Medicines Agency on Friday.
It is recommended as a treatment, in combination with Xeloda, for patients with advanced or metastatic breast cancer whose tumors over-express protein HER2.
The small study reviewed here offers some good news for women diagnosed with HER2-positive breast cancer that has spread to the brain and is not responding to Tykerb (chemical name: lapatinib) alone. It also offers more evidence that the combination of Tykerb and Xeloda (chemical name: capecitabine) can stop advanced, HER-positive cancer from growing better than either Tykerb or Xeloda alone.
When Tykerb was combined with Xeloda, the combination reduced the amount of HER2-positive breast cancer in the brains of 28 of the 49 women in the study. The reduction in cancer ranged from 20% to 50%.
The most common side effects were redness and tingling in the hands and feet, diarrhea, and nausea.
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 cell's 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. Also, Tykerb can be taken in pill form, which might be easier than an IV for some people.
Tykerb has been approved by the U.S. Food and Drug Administration to be given in combination with Xeloda to treat advanced, HER2-positive breast cancer that has stopped responding to anthracyclines, taxanes, and Herceptin. Research has shown that the combination of Tykerb and Xeloda can stop advanced, HER-positive cancer from growing nearly twice as long compared to Xeloda alone.
If you've been diagnosed with HER2-positive breast cancer that has spread and is not responding to treatment, you might want to talk to your doctor about the results of this study. So far, Tykerb hasn't improved overall survival -- the length of time that the women lived, with or without the cancer progressing. More research and longer follow-up time is necessary to know if Tykerb will improve overall survival.
Stay tuned to breastcancer.org for the very latest information on new treatments for recurrent and metastatic breast cancer.
Breastcancer.org 7 East Lancaster Avenue, 3rd Floor Ardmore, PA 19003
Learn more about our commmitment to your privacy
© 2008 Breastcancer.org - All rights reserved.
Breastcancer.org is a non-profit organization dedicated to providing information and community to those touched by this disease. Learn more about our commitment to providing complete, accurate, and private breast cancer information.