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| |  Taxotere Combination Effective First-Line Treatment of Metastatic Breast Cancer Denver, Colorado, May 20, 1997 -- The anticancer agent Taxotere(R) (docetaxel) in combination with the anthracycline Adriamycin(R) (doxorubicin) and cyclophosphamide is highly active against metastatic (spreading) breast cancer, according to a phase II study presented today at the annual meeting of the American Society of Clinical Oncology (ASCO). "This study is significant because we combined Taxotere with an anthracycline, and reported a high overall response rate in metastatic breast cancer without observing any clinical sign of cardiac toxicity, a common side effect associated with doxorubicin," said Jean-Marc Nabholtz, M.D., Chair of the Alberta Breast Cancer Program, senior medical oncologist at Cross Cancer Institute, Edmonton, Alberta, Canada, and lead investigator. "The study shows that this combination of the disease, since our ultimate goal is to try to keep the cancer from spreading after initial diagnosis." Study Background In the study, 36 patients with measurable metastatic breast cancer who had not undergone prior treatment with anthracyclines or taxoids were treated with infusions of Taxotere, doxorubicin and cyclophosphamide. Of the 28 evaluable patients, eighteen percent (5 of 28) of the patients showed a complete response, while 64 percent (18 of 28 patients) experienced a partial response. The overall response rate was 82 percent (23 of 28 patients). At five months there was no disease progression or clinical evidence of cardiac toxicity. A partial response is defined as a 50 percent or greater reduction in measurable tumour size, and a complete response is a complete disappearance of all clinical and radiological signs of cancer; however, it does not mean a cure. The overall response rate is the partial response rate plus the complete response rate. Based on 165 courses of treatment, safety data showed neutropenia to be the most common side effect. Other clinically significant side effects included febrile neutropenia, nausea, vomiting, diarrhea, and fatigue. Clinical evidence of cardiac toxicity was not observed in any patient. Breast Cancer Breast cancer is an abnormal cell growth originating in glandular breast tissue. If not diagnosed early, these cells invade surrounding tissues and spread (metastasize) through the blood and lymph system. Common sites of breast cancer metastases include the bone, lungs, liver, brain, and lymph nodes. Each year there are 570,000 new cases of breast cancer reported worldwide. In the European Community, the World Health Organisation reported 157,000 new cases and 68,800 deaths in 1990, the last year for which data are available. Although many women are initially treated successfully, about 50 percent of breast cancer patients will eventually have a relapse or recurrence of the disease.
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