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Adding lapatinib to capecitabine improves treatment of advanced breast cancer
Capecitabine and lapatinib yielded a 36.9-week time to progression compared with 19.7 weeks for capecitabine alone.
ATLANTA — A phase-3 international multicenter clinical trial has shown that lapatinib and capecitabine controls cancer growth more effectively than capecitabine alone in women with advanced HER2/neu-positive breast cancer refractory to trastuzumab.
“Trastuzumab [Herceptin, Genentech] is a very effective drug that has substantially improved the available treatments for women with metastatic breast cancer that produces large amounts of the HER2/neu protein. However, because trastuzumab eventually stops controlling these cancers, there is a need for effective alternative treatments that block the function of HER2/neu in another way,” said Charles E. Geyer Jr., MD, director of breast medical oncology at Allegheny General Hospital in Pittsburgh. “These results indicate that lapatinib [Tykerb, GlaxoSmithKline] can be effective in helping control the growth of breast cancers that are not being controlled by trastuzumab.”
The study was presented here at the 2006 ASCO Annual Meeting.
Late breaking results
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The study’s primary endpoint was time to progression, which was observed from March 2004 through November 2005. At the time of an interim analysis, researchers had evaluated 321 women with HER2/neu-positive advanced or metastatic breast cancer who were refractory to treatment with an anthracycline drug, a taxane and trastuzumab. Those women were randomly assigned to receive either lapatinib and capecitabine (Xeloda, Roche; n=160) or capecitabine alone (n=161).
The time to progression in women taking lapatinib and capecitabine was almost double (36.9 weeks) that of women who received capecitabine alone (19.7 weeks), Geyer said. Additionally, lapatinib seemed to prevent metastases to the brain. Researchers observed four instances of brain metastases in the capecitabine plus lapatinib group vs. 11 in the capecitabine alone group. Geyer called for further investigation to confirm lapatinib’s preventive effects on distal metastases. Adverse events were similar between the two groups. Women in the lapatinib group were more likely to experience mild-to-moderate diarrhea (58% vs. 39%) and rash (30% vs. 18%).
For more information:
- Geyer C, et al. Lapatinib added to capecitabine improves treatment of patients with advanced breast cancer compared with capecitabine alone. Late breaking abstract, presented at: 2006 ASCO Annual Meeting; June 2-6; Atlanta.