Drug May Slow Advanced Breast Cancer
Drug, Called Tykerb, May Hold off Cancer's Progression in Some Patients
June 5, 2006 -- An experimental drug called Tykerb might delay the
progression of advanced breast cancerin
some patients, new research shows.
The findings were presented in Atlanta at the American Society of Clinical
Oncology's annual meeting. The researchers included Charles Geyer, MD, director
of Breast Medical Oncology at Pittsburgh's Allegheny General Hospital.
Tykerb, which has not yet been submitted for FDA approval, is taken as a
pill. It targets a protein called HER2/neu, which is involved in the growth of
Tykerb blocks part of the HER2/neu's receptor.
About 20% to 25% of breast cancer patients have HER2/neu breast cancer,
which may be more aggressive and possibly more resistant to chemotherapy and
hormone therapy than other forms, notes the Susan G. Komen Breast Cancer
Breakthroughs for Women Fighting
Geyer's study included 321 patients with advanced breast cancer that was
positive for HER2/neu.
Participants had already gotten chemotherapy and had taken the drug
Herceptin, which also targets HER2/neu breast cancer.
Geyer and colleagues split the patients into two groups. Both got the
chemotherapy drug Xeloda. One group also took Tykerb.
Interim results showed that 114 cancers had progressed. On average, breast
cancer progressed after 36.9 weeks (about 9.2 months) with Tykerb and Xeloda,
compared with 19.7 weeks (about 4.9 months) with Xeloda alone.
At that point, the researchers recommended stopping enrollment in the study
and reporting the interim results. In their abstract, they write that Tykerb
provided "a clinically meaningful" impact on HER2/neu breast cancer in
patients pretreated with chemotherapy and Herceptin.
more common in patients taking both Tykerb and Xeloda than in those only taking
The two groups had similar percentages of patients who quit the study: 11%
for Xeloda alone; 14% for Tykerb plus Xeloda.
About 2% of patients taking Tykerb with Xeloda had a 20% drop in the pumping
strength of the heart's left ventricle, compared to 1% of those only taking
That problem appeared to be temporary. In all patients, the heart's left
ventricle regained its previous pumping strength, the study shows.
The study was funded by the drug company GlaxoSmithKline, Tykerb's maker.
GlaxoSmithKline is a WebMD sponsor.
GlaxoSmithKline plans to submit Tykerb for regulatory approval in the U.S.
and Europe in the second half of 2006, states a company news release.