Herceptin® Approved for Early-stage Breast Cancer

Herceptin® Approved for Early-stage Breast Cancer.

Herceptin® (trastuzumab) has been approved by the U.S. Food and Drug Administration (FDA) for use in the post-surgery treatment of early-stage breast cancer that is HER2-positive and node-positive. The approval specified that Herceptin be given in combination with the chemotherapy drugs doxorubicin, cyclophosphamide, and paclitaxel.

Though a diagnosis of breast cancer will always be a shock, women diagnosed with early-stage breast cancer can be reassured that the cancer was caught early, when treatment has the best chance of success. Furthermore, recent advances in the treatment of early-stage breast cancer promise to further improve patient outcomes.

Twenty to thirty percent of breast cancers overexpress (make too much of) a protein known as HER2. Overexpression of this protein leads to increased growth of cancer cells and a worse breast cancer prognosis. Fortunately, the development of treatments that specifically target HER2-positive cells has improved prognosis for women with HER2-positive breast cancer.

Herceptin is an agent that recognizes and binds to HER2-positive cells. The effects of Herceptin are thought to include decreased cell growth and increased cell death.

Use of Herceptin was initially evaluated in women with metastatic breast cancer; in these women, treatment with chemotherapy plus Herceptin slowed cancer progression and improved survival compared to treatment with chemotherapy alone. Herceptin was first approved for the treatment of metastatic breast cancer in 1998.

More recently, Herceptin has produced good results in women with early-stage HER2-positive breast cancer. A combined analysis of two phase III clinical trials, published in October 2005 in the New England Journal of Medicine, reported that women who received post-surgery treatment with chemotherapy and Herceptin were half as likely to develop a cancer recurrence as women given chemotherapy alone.

Based on these results, Herceptin-given in combination with doxorubicin, cyclophosphamide, and paclitaxel-is now approved for the post-surgery (adjuvant) treatment of women with HER2-positive, node-positive breast cancer.

Women who have been diagnosed with HER2-positive, node-positive breast cancer may wish to talk with their doctor about the risks and benefits of a treatment regimen that includes Herceptin. Potential risks of Herceptin include an increased risk of heart problems.

Reference: Genentech Press Release. FDA Approves Herceptin for the Adjuvant Treatment of HER-2-positive Node-positive Breast Cancer. November 16, 2006. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=10207 (accessed November 17, 2006).

Related News:Herceptin® Continues to Show Benefits in Early Breast Cancer (6/12/2006)

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