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| |  ASCO MEETING: Epirubicin Treatment Regimen Improves Early Breast Cancer Survival ATLANTA, GA -- May 17, 1999 -- Premenopausal women with early breast cancer have a significantly better chance of living longer when treated with a chemotherapy regimen including the anti-cancer drug epirubicin compared to a current standard therapy, according to data presented today at the 35th annual meeting of the American Society of Clinical Oncology (ASCO). In a large study involving more than 1,000 women, researchers demonstrated that adjuvant treatment (after breast cancer surgery) with a combination of drugs containing epirubicin (cyclophosphamide, epirubicin, fluorouracil, or CEF) improved six-year survival rates in premenopausal women with node-negative, grade II-III tumours by 10 percent (93 percent versus 83 percent), when compared to treatment with a commonly-used drug combination known as CMF (cyclophosphamide, methotrexate and fluorouracil). "This study shows that an epirubicin-based regimen offers highly significant disease-free and overall survival advantages for premenopausal breast cancer patients compared to a CMF regimen," said Dr. Henning Mouridsen, principal trial investigator and general secretary at the Danish Breast Cancer Cooperative Group, Copenhagen University Hospital, Denmark. "By using the epirubicin-based regimen instead of CMF, we can decrease the risk of death from breast cancer in premenopausal women by approximately 20-25 percent." Breast cancer is the most common cancer among women in industrialised countries and remains a major killer. In 1998, almost 800,000 women world-wide were diagnosed with breast cancer and 314,000 women died from the disease, according to the World Health Organization. "The epirubicin combination and CMF are standard treatments around the world, so this study is of special importance," Dr. Mouridsen said. "Although 10-year data will offer a true test of the treatment's success, the six-year survival data is very promising." The trial has followed for six years 1,195 pre- and post-menopausal women with early breast cancer. The study considered three sub-groups -- premenopausal women with node-negative, grade II-III tumour (sub-group A); premenopausal women with node-positive, receptor-negative or unknown tumour (sub-group B); and postmenopausal women with node-positive, receptor-negative tumour (sub-group C). Following surgery, patients were randomly assigned to receive first-line chemotherapy with either a standard CMF combination or CEF, the epirubicin-containing treatment. Node-positive tumours refer to tumours that have spread from the breast to the lymph nodes under the armpit. Receptor-negative tumours refer to tumours that are not sensitive to hormones (such as estrogen or progesterone) and therefore not treatable with hormonal therapy. Grade II-III tumours have an increased risk of recurrence; grade III tumours are the most aggressive. After six years, the combined overall survival rate in epirubicin-treated women from sub-groups A and B was 76 percent, compared to 69 percent for those on the CMF combination. (A 24 percent death rate compared with 31 percent results in an absolute reduction of seven percent and a relative reduction of approximately 20-25 percent.) In sub-group A, women treated with CEF had a survival rate of 93 percent, while those receiving CMF had a survival rate of 83 percent. Women in sub-group B who were treated with CEF had a survival rate of 66 percent versus a survival rate of 60 percent for CMF. No statistically significant difference between treatments was observed in sub-group C (50 percent versus 48 percent). Hematological toxicities were evenly distributed in the two groups. Other events that occurred more frequently in the CEF group, included transient hair loss (87 percent versus seven percent) and loss of menstrual function (80 percent versus 60 percent). First introduced in 1982, epirubicin has been available in more than 80 countries for the past 15 years and is a standard of care for breast cancer world-wide. The United States Food and Drug Administration (FDA) is currently considering epirubicin for treatment of breast cancer as a component of adjuvant therapy following surgery and for locally advanced or metastatic breast cancer. "The study results concerning epirubicin will have a major impact on the management of breast cancer," Dr. Mouridsen said. "Except in the United States, where epirubicin has not yet been approved, women with early breast cancer are generally treated with a regimen based on either epirubicin or methotrexate. This study shows that epirubicin may be the better treatment option for premenopausal women." In the U.S., two standard chemotherapies, CMF and CAF (cyclophosphamide, adriamycin, fluorouracil), have been shown to have similar survival rates when used in adjuvant treatment. Adriamycin and epirubicin belong to the same class of drugs called anthracyclines. Patients with breast cancer in its early stages are usually treated first with surgery to remove as much of the tumour from the breast as possible. However, even when the tumour has been removed, the disease may spread, often first to the lymph glands in the armpit (the axillary nodes). To improve chances of survival of these patients, chemotherapy with combination drugs (such as CMF and CEF) is given following surgery to kill any cancerous cells that remain in the body, an approach referred to as systemic adjuvant chemotherapy. Large-scale clinical trials have shown that both the risk of cancer recurring and death rate are significantly lower in patients who receive systemic adjuvant chemotherapy compared with patients who received primary treatment alone.
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