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| |  Taxotere First Drug To Outperform Adriamycin in Metastatic Breast Cancer Denver, Colorado, May 20, 1997 -- The anticancer agent Taxotere(R) (docetaxel) was shown to be more effective than Adriamycin(R) (doxorubicin) in patients with metastatic breast cancer, according to a Phase III study presented today at the annual meeting of the American Society of Clinical Oncology. "Taxotere is the first drug shown in a clinical study to be more effective than doxorubicin in the treatment of metastatic breast cancer,” said Dr. Stephen Chan, Clinical Oncologist, City Hospital Breast Clinic, Nottingham, England. "This is significant because doxorubicin is the current standard treatment and the most widely used chemotherapeutic agent for metastatic breast cancer." The patients who received Taxotere showed a 50 percent better overall response rate when compared with the doxorubicin patients (47.2 percent for Taxotere and 31.5 percent for Adriamycin). Study Background A total of 326 patients were entered in the multicentre study. One hundred sixty-one patients received 100 mg/m2 of Taxotere as a one hour infusion given every three weeks and 185 received 75 mg/m2 of doxorubicin as a short infusion every three weeks. Of the 161 Taxotere patients, 63 (39.1 percent) had a partial response and 13 (8.1 percent) had a complete response. The overall response rate was 47.2 percent. Of the 165 doxorubicin patients, 45 (27.3 percent) had a partial response and 7 (4.2 percent) had a complete response. The overall response rate was 31.5 percent. 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. "13 patients receiving doxorubicin dropped out of the study due to cardiac toxicity," according to Dr. Chan. We observed three dropouts in the Taxotere group due to fluid retention. "Both drug groups exhibited a similar incidence of neutropenia, infection and asthenia. Although side effects were observed in both groups, taxotere showed a lower incidence of nausea, vomiting and stomatitis, and doxorubicin showed a lower incidence of diarrhea." Doxorubicin, introduced in 1979, has been considered the most effective single agent for the first-line treatment of advanced breast cancer. This study shows that, at approximately equal toxicity level, Taxotere appears to be more effective against metastatic breast cancer. Combining these two effective agents is likely to yield even greater efficacy and this is being studied in many settings. 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 United States, 183,000 new cases are diagnosed each year, and nearly 45,000 patients die annually. 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 disease. In the United States, metastatic breast cancer is the leading cause of death for women between the ages of 40 and 55. Taxotere is a new chemical entity that inhibits cancer cell growth and division, which ultimately causes cell death. Taxotere has been studied extensively in clinical trials involving thousands of patients worldwide. Additional clinical trials are ongoing to investigate the potential use of Taxotere to treat other tumour types.
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