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| |  ICACT: Taxotere And Adriamycin Combo Effective For Breast Cancer PARIS, FRANCE -- February 3, 2000 -- Weekly administration of the chemotherapeutic agent Taxotere(R) (docetaxel) in combination with Adriamycin(R) (doxorubicin) is a well-tolerated and effective regimen for the treatment of advanced breast cancer, according to preliminary results of a phase II trial presented at the 10th International Congress on Anti-Cancer Treatment (ICACT). "Our results suggest that dose-dense administration of docetaxel provides impressive antitumor efficacy and an acceptable safety profile," Dr. Gumersindo Perez-Manga, who is the Head of Medical Oncology at the Gregorio Maranon Hospital in Madrid, Spain, said. "We continue to be encouraged with these results as well as prior data that shows a weekly schedule of docetaxel to demonstrate increased antitumor activity with less toxicity."
Dose-dense administration or dose intensity refers to the shortest intervals between cycles of chemotherapy that may result in improved efficacy and tolerance. Early results in 42 women with metastatic or locally advanced breast cancer who received a combination of weekly docetaxel and doxorubicin showed an overall response rate of 77 percent. The overall response rate is the sum of the complete and partial response rates. A complete response is defined as a complete disappearance of clinical and x-ray signs of cancer, while a partial response refers to a 50 percent or greater decrease in measurable tumor size. All women enrolled in the trial had a diagnosis of metastatic or locally advanced breast cancer with measurable and/or evaluable disease and an adequate performance status. Those locally advanced patients who had undergone prior chemotherapy or radiotherapy for breast cancer were excluded. Patients received four cycles of docetaxel, 36 mg/m2, given weekly in combination with doxorubicin every 28 days. Docetaxel was administered as three weekly infusions followed by a one-week non-treatment period. It is usually administered intravenously every three weeks, and its recommended dose is 60-100 mg/m2. Doxorubicin, 50 mg/m2, was given on day one. After four cycles of chemotherapy, mammography was performed followed by surgery and/or radiotherapy. All patients were premedicated with three doses of dexamethasone at 8 mg. Twelve of 16 patients with operable breast cancer and 23 of 31 with inoperable advanced or metastatic disease were evaluable for response. Four of the evaluable women with operable breast cancer and four with inoperable advanced or metastatic disease had a complete remission, and seven with operable breast cancer and 12 with inoperable or advanced metastatic disease had a partial remission - for an overall response rate of 77 percent. The main hematologic toxicity was neutropenia (grade III or IV in ten percent of cycles and febrile neutropenia in five percent of cycles). The main grade 3 non-hematologic toxicities included alopecia, fatigue, nail disorders, nausea, vomiting, and stomatitis. There was no evidence of grade IV non-hematologic toxicity. Dr. Perez-Manga emphasized that the results are preliminary and added that future analysis may confirm the improved clinical efficacy and tolerance of dose-dense administration of docetaxel in combination with doxorubicin. Dose-dense docetaxel may also be a convenient therapeutic option as an outpatient regimen in patients with locally advanced breast cancer. Breast cancer is an abnormal cell growth originating in breast tissue. If not diagnosed and treated early, these cells can invade surrounding tissue and spread through the blood and lymph node system. Common sites of breast cancer metastases include the bone, lungs, liver, brain, and lymph nodes. The incidence of breast cancer has been increasing steadily since the 1930s. It is the most common malignancy affecting women, accounting for 20 percent of all female cancers in industrialized countries, and over 780,000 new cases are reported each year worldwide. Related Links: Taxotere (docetaxel) and Adriamycin (doxorubicin).
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