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GlaxoSmithKline Announces Data on TYKERB(R) (Lapatinib) Plus Capecitabine for the Treatment of HER2 Positive Breast Cancer Brain Metastases
Date:12/17/2007

n metastases.

"I know first hand that HER2-positive breast cancer can have unique, difficult-to-treat complications. Brain metastases can be particularly devastating for patients, as they may cause blurred vision, speech impairments and can limit patients' ability to engage in even simple day-to-day activities," said Christine Druther, MSPH, founder and president, HER2 Support Group. "We look forward to the results of any and all research in the treatment of HER2-positive breast cancer and its complications."

Data Presented on Abstract 6076(1)

In this study, the combination of TYKERB plus capecitabine showed a reduction in HER2-positive breast cancer that had spread to the brain and had progressed on TYKERB alone. Preliminary results are available from the initial 49 patients who enrolled in the TYKERB plus capecitabine extension arm as of March 2007. Exploratory analysis revealed 18 patients (37 percent) experienced at least a 20 percent volume reduction in brain metastases, without progression of their disease outside of the brain, increase in steroid requirements or worsening of neurological signs or symptoms, and a median reduction in brain metastases of 4.8 cm(3). Of these 18 patients, 10 patients (20 percent) experienced at least a 50 percent volume reduction in brain metastases with a median reduction in brain metastases of 7.1 cm(3). As of September 2007, three patients remained on the parent study with TYKERB monotherapy and of the 51 patients enrolled in the extension arm with TYKERB plus capecitabine, eight remained on lapatinib plus capecitabine.

Of the 51 patients enrolled in the extension arm, 10 (20 percent) who received TYKERB plus capecitabine experienced a partial response and 20 patients (39 percent) achieved stable disease. The disease progressed in fifteen patients (29 percent) who received the combination. The status of 6 patients (12%) was unknown at the time of reporting.

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