Tykerb Tablets In Combination With Paclitaxel As First-Line Treatment For Patients With Metastatic Or Relapsed Advanced Breast Cancer

Paclitaxel is one of the most commonly used chemotherapies in breast cancer. Therefore, the evaluation of Tykerb tablets in combination with this treatment is of high importance.


This large, randomized, multicenter, prospective trial evaluated a total of 580 patients who were either negative or untested for HER2 overexpression and had not previously been treated with trastuzumab. While the combination therapy did not demonstrate an incremental benefit for patients with HER2 negative disease, an analysis of 91 patients who were retrospectively identified as having HER2 positive disease showed that Tykerb tablets plus paclitaxel increased progression-free survival in this subpopulation.


Results, as follows, represent the combination of Tykerb tablets plus paclitaxel (n=52) versus paclitaxel alone (n=39), respectively, in patients with HER2 positive disease:


• Median progression-free survival was 7.9 months versus 5.2 months (p=0.007)

• Median duration of response was 7.4 months versus 5.5 months

• Complete or partial response occurred in 60 per cent of patients versus 36 per cent (p = 0.027)

• There was a trend towards improvement in overall survival after 39 deaths had been reported. Data presently available indicate a median survival of 24 months versus 19 months (p=0.160), but data are not yet fully mature


Data from this trial of Tykerb tablets plus paclitaxel versus paclitaxel alone as first-line treatment in patients with newly diagnosed metastatic breast cancer not previously treated with trastuzumab have provided the first evidence of activity in the HER2 positive subgroup that the combination significantly improves progression-free survival of the disease compared with the chemotherapy alone.


"These results have the potential to directly impact clinical practice and may benefit patients in the first-line treatment setting," said Dr. Angelo Di Leo, Director of the Medical Oncology Unit, Hospital of Prato (Italy) and lead investigator of this trial. "Tykerb in combination with paclitaxel is a step in the right direction as the oncology community explores potential combination therapies to individualize treatment for breast cancer patients."


The most common adverse events (AEs) included rash, diarrhea, nausea, vomiting, neutropenia and mucositis. The addition of Tykerb tablets to paclitaxel resulted in an increase in diarrhea and rash. Severe AE-related deaths were higher in the combination arm (2.7 per cent vs. 0.6 per cent).


Several additional Phase III trials combining Tykerb tablets with taxanes are being conducted in patients with HER2 positive disease.


About Tykerb Tablets















Tykerb is an investigational drug that is in a class of cancer treatments called targeted therapies, designed to interfere with specific cellular processes or disease mechanisms common in cancer.


A pivotal Phase III trial showed that Tykerb tablets in combination with Xeloda nearly doubled time to progression (8.4 months versus 4.4 months with capecitabine alone) for women with HER2 positive advanced breast cancer whose disease had progressed despite receiving prior therapy including anthracycline, a taxane and trastuzumab. The most common adverse events during treatment with Tykerb tablets plus capecitabine were diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue.6


GSK has a comprehensive clinical trial program that is actively studying Tykerb tablets in other breast cancer settings and other cancers to better identify patient populations that may respond to therapy. The landmark Phase III study TEACH (Tykerb Evaluation After CHemotherapy) trial has reached a key milestone, enrolling more than 1,000 patients. TEACH is designed to investigate whether adjuvant treatment with Tykerb tablets will improve disease-free survival in women with early stage HER2 positive breast cancer, including those with positive and negative node involvement.


About GlaxoSmithKline


GlaxoSmithKline - one of the world's leading research-based pharmaceutical and health-care companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. In Canada, GlaxoSmithKline is among the top 15 investors in research and development, contributing more than $176 million in 2006 alone. GSK is an Imagine Caring Company, and is consistently recognized as one of the 50 Best Employers in Canada. For company information, please visit gsk.ca.


Tykerb™ is a trademark of the GlaxoSmithKline.

Herceptin® is a registered trademark of Hoffmann-La Roche Ltd.

Taxol® is a registered trademark of Bristol-Myers Squibb.

Taxotere® is a registered trademark of sanofi-aventis Canada Inc.


View drug information on Herceptin; Taxol; Taxotere.