Breast Cancer Treatment: Ellence™
One hundred and eighty thousand new cases of breast cancer are diagnosed every year, making breast cancer the most common cancer in women in the United States. Breast cancer is the second-leading cause of cancer deaths for women in the US. One out of eight women will develop breast cancer in her lifetime.
A new treatment for breast cancer, which could potentially save the lives of thousands of women received FDA approval in September of 1999. The drug is called Ellence™ (epirubicin hydrochloride injection). The FDA approved Ellence as a component of adjuvant therapy following resection of early breast cancer that has spread to the lymph nodes under the arm.
Ellence, which was first granted orphan drug designation, has been used to treat nearly one million women with breast cancer worldwide. The FDA approval makes Ellence the first and only chemotherapy agent approved by the FDA for the adjuvant treatment of node-positive early breast cancer.
The approval of Ellence was based on mature data from a pivotal trial which demonstrated that in combination with cyclophosphamide and fluorouracil, it provides greater relapse-free and overall survival benefits than a current standard therapy that uses CMF (cyclophosphamide, methotrexate, flurorouracil) in patients with early breast cancer.
Adjuvant therapy--a mainstay of treatment for early breast cancer--is drug therapy following initial breast cancer surgery to destroy any remaining cancer cells. Two commonly used adjuvant chemotherapies, CMF and AC {Adriamycin® (doxorubicin hydrochloride), cyclophosphamide}, have been shown to have similar survival rates.
However, Ellence combined with cyclophosphamide and fluorouracil has been shown to provide a significant survival advantage compared to CMF when used as adjuvant chemotherapy in early node-positive breast cancer. Approximately 75,000 women are eligible for adjuvant therapy annually.
Data indicates that women with early breast cancer who are treated with Ellence experience a 19% reduction in the risk of cancer recurrence, and reduce their relative risk of death by 29% over women treated with more traditional chemotherapies.
Side effects of therapy with Ellence are generally predictable and manageable, and are similar to those observed with other chemotherapies. The most common side effects include hair loss, nausea, vomiting, mouth sores, and a low white blood cell count caused by myelosuppression (bone marrow suppression) which can be severe. Side effects normally subside at the completion of treatment.
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