[Lolly]

Here's an excerpt from GSK's web page on the data from Tykerb trials released last summer, along with the link to the site:

Tykerb Activity in Brain Metastases Associated with Breast Cancer
http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=843
"...analysis from the EGF100151 study (Late-Breaking Abstract) suggests that Tykerb may play a role in decreasing the occurrence of brain metastases. Indeed, in the interim analysis, only 4 patients experienced CNS relapse in the Tykerb -capecitabine arm versus 11 in the capecitabine alone arm.1
Another study (abstract #503) being presented today at ASCO provides preliminary evidence suggesting that Tykerb may be effective in treating brain metastases associated with breast cancer. The Phase II trial was conducted by investigators at the Dana-Farber/Harvard Cancer Center, the Universityof North Carolina, and Georgetown Universityand was sponsored by the National Cancer Institute’s Cancer Therapeutic Evaluation Program (CTEP). The trial evaluated Tykerb in 39 patients with ErbB2 positive breast cancer who had developed CNS metastases while on trastuzumab. As reported in the abstract, two patients achieved partial response as measured by RECIST, a linear measure of solid tumors. An additional five patients achieved stable disease for ≥ 16 weeks. Volumetric analysis, which is a more precise three dimensional measure of tumor volume, was performed in 20 patients. Eight of the patients (40 percent) showed volumetric decline in CNS lesions – five patients showed ≥ 30 percent volumetric decline and an additional three patients showed 15-30 percent volumetric decline. Although the trial did not demonstrate the hypothesized level of activity as assessed by RECIST, the study concludes that there is sufficient evidence of preliminary clinical effect to suggest that Tykerb can penetrate the CNS.2 The most common adverse events with Tykerb were diarrhoea (grade 3, 21 percent), fatigue (grade 3, 16 percent), and rash (grade 3, 5 percent).

Following the encouraging results from the CTEP trial, Tykerb is now being studied by GSK in a large, international, randomized Phase II study designed to assess the impact of Tykerb monotherapy on brain metastases by monitoring lesions in the brain using magnetic resonance imaging, a volumetric measure."