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TAXOTERE (R) (DOCETAXEL) SHOWS OVERALL RESPONSE RATES OF MORE THAN 50 PERCENT IN PREVIOUSLY UNTREATED AND ANTHRACYCLINE-RESISTANT METASTATIC BREAST CANCER PATIENTS

 JERUSALEM, Nov. 15 /PRNewswire/ -- Important clinical data on the new antitumor drug, Taxotere(R) (docetaxel) were released yesterday at the 7th European Conference on Clinical Oncology and Cancer Nursing (ECCO 7), in Jerusalem. Taxotere(R) acts as a potent inhibitor of cancer cell division by acting on the cell's internal skeleton.
 The results were presented by researchers from the United States and Canada on the use of Taxotere(R) in women with metastatic breast cancer, including anthracycline-resistant disease. They demonstrate that Taxotere(R) is highly active in untreated metastatic breast cancer with overall response rates of 67-76 percent in three trials, and also shows significant antitumor activity in patients resistant to doxorubicin, the most active single agent for breast cancer.
 Presenting the results of the National Cancer Institute of Canada Clinical Trials Group study in metastatic breast cancer, Dr. Elizabeth Eisenhauer from Kingston, Canada, commented, "Taxotere(R) is an extremely effective antitumour agent in metastatic (advanced) breast cancer." She presented the results of a study of 49 previously untreated women with metastatic breast cancer, about one-third of whom had received previous adjuvant chemotherapy. The dose of Taxotere(R) used initially was 100 mg/m2 intravenously as a one-hour infusion, every three weeks, without premedication. In the last 16 patients, this dose was reduced to 75 mg/m2 (to improve the safety profile). Liver metastases were present in 28 cases, lung in 16, soft tissue in 24, bone in 30, and skin in 15 patients. Overall, 23 patients had metastases at more than two sites. To date, 46 patients are evaluable for toxicity and 45 for response.
 "Five patients achieved a complete response," said Dr. Eisenhauer, "and 25 a partial response, with an excellent overall response rate of 67 percent (95 percent Cl 51-80 percent). Among the 12 evaluable patients treated with a dose of 75 mg/m2, one patient demonstrated a complete response and six patients showed partial responses, giving a response rate of 58 percent (95 percent Cl 27-84 percent)."
 Two other leading researchers, Dr. Pierre Fumoleau for EORTC(A) Clinical Screening Group and Dr. Seidman for Memorial Sloan-Kettering Cancer Center, earlier this year reported similarly positive results in studies of previously untreated patients with metastatic breast cancer, which showed overall response rates of 72 percent and 76 percent, respectively.
 Good results have also been achieved with Taxotere(R) in patients with metastatic breast cancer who have demonstrated primary or secondary resistance to doxorubicin. Dr. Vincente Valero from the University of Texas, M.D. Anderson Cancer Center, Houston, presented preliminary data on 33 patients with anthracycline-resistant metastatic breast cancer who had previously received one to three chemotherapy regimens. Many of them have three or more sites with metastases. Liver metastases were present in 15 patients. Within this group, Dr. Valero reported that 18 patients (55 percent) achieved partial responses to Taxotere(R), a highly significant result for a potentially difficult-to-treat patient population. The use of premedication has decreased the degree of toxicity as well as its onset.
 Similarly, in another U.S.-based study of Taxotere(R), Dr. Peter Ravdin from The University of Texas Health Science Center, San Antonio, demonstrated a 53 percent response rate in 26 patients with anthracycline-resistant breast cancer. Emphasizing the diversity of the response sites, Dr. Ravdin explained that these included liver, lung, chest wall and soft tissue. Myelosuppression (neutropenia of short duration) was the dose-limiting toxicity.
 Investigators have noted some hypersensitivity reactions which have led to certain study protocols being amended to include effective premedications. Encouraging results were presented at the conference showing that severe hypersensitivity reactions can be completely blocked in most patients.
 Taxotere(R) is a new antitumor agent in the taxoid group with good clinical activity against non-small cell lung cancer and breast cancer. In addition, it has shown interesting results in head and neck cancer, gastric cancer, soft-tissue sarcomas, ovarian cancer, melanoma and pancreatic cancer. Taxotere(R) has been found to inhibit cancer cell division by acting on the cell's internal skeleton, which is made up of elements called microtubules. Microtubules assemble and disassemble during the cell cycle, but Taxotere(R) blocks the disassembly, thus preventing cancer cells from dividing.
 (A) The European Organization for Research and Treatment of Cancer.
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Date:Nov 15, 1993
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