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| |  Taxotere The First Breast Cancer Drug to Outperform Adriamycin SAN ANTONIO, TX -- December 4, 1997 -- The chemotherapeutic agent Taxotere(R) (docetaxel), has shown superior activity in reducing tumors compared to Adriamycin(R) (doxorubicin), the current standard of treatment for women with metastatic (spreading) breast cancer, according to the final results of a Phase III clinical trial presented today at the 20th Annual San Antonio Breast Cancer Symposium. Doxorubicin, introduced in 1979, is considered to be the most effective single agent in the first-line treatment of metastatic breast cancer. Taxotere is the first anticancer agent to show superior activity to doxorubicin. "This study clearly confirms preliminary results which showed Taxotere to be a more active agent than doxorubicin in patients with metastatic breast cancer," said John Crown, M.D., of St. Vincent's Hospital in Dublin, Ireland and chairman of the Irish Clinical Oncology Research Group. Patients treated with Taxotere showed a 50 percent better overall response rate compared to patients treated with doxorubicin (48 percent for Taxotere versus 33 percent for doxorubicin). Among resistant patients (those who had failed on previous regimens containing alkylating agents) and those with liver metastases, the response rates were significantly higher than doxorubicin (47 percent versus 24 percent for resistant patients and 54 percent versus 27 percent for patients with liver metastases). Patients treated with Taxotere also showed a longer time to disease progression than those treated with doxorubicin (26 weeks versus 21 weeks) and a significantly faster onset of response (12 weeks versus 23 weeks). The overall response rate is the partial response rate plus the complete response. A partial response is defined as a 50 percent or greater reduction in measurable tumor size, and a complete response is a complete disappearance of all clinical and radiological signs of cancer. A total of 326 women from 16 countries were entered into the study, all of whom had previous therapy with alkylating agents. One hundred sixty-one patients received 100 mg/m2 of Taxotere as a one-hour infusion given once every three weeks and 165 patients received 75 mg/m2 of doxorubicin as a short infusion every three weeks. Of the 161 Taxotere patients, approximately 41 percent had a partial response and seven percent had a complete response. Of the 165 doxorubicin patients, 29 percent had a partial response rate and four percent had a complete response. According to Dr. Crown, the increased responses seen in the Taxotere group were achieved with a predictable and less severe toxicity profile. While 13 patients receiving doxorubicin were removed from the study due to cardiac complications, including four deaths, no Taxotere patients were removed due to The study also confirmed that at approximate equally myelosuppressive (bone marrow depression) doses, both drugs exhibited a similar incidence of neutropenia (a decrease in white blood cells), infection and asthenia (weakness). A higher incidence of febrile neutropenia and infections requiring hospitalizations were seen with doxorubicin. While Taxotere showed a lower incidence of nausea, vomiting, and stomatitis (inflammation of the mucous membrane of the mouth), doxorubicin showed a lower incidence of diarrhea. "Because of the lack of overlapping toxicities, combining these two agents is likely to yield even greater efficacy and this is currently being studied in many settings." More information on: Taxotere
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