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| |  DG DISPATCH - ICACT: Weekly Docetaxel Plus Doxorubicin Effective In Advanced Breast Cancer By Jill Stein Special to DG News
PARIS, FRANCE -- January 31, 2000 -- Preliminary results of a phase II trial suggest that weekly administration of docetaxel in combination with doxorubicin is a well-tolerated and effective regimen for the treatment of advanced breast cancer.
"Our results suggest that dose-dense administration of docetaxel provides impressive anti-tumor efficacy and an acceptable safety and tolerability profile," said Professor Gumersindo Perez-Manga, with the Gregorio Maranon Hospital in Madrid, Spain, speaking at the 10th International Congress on Anti-Cancer Chemotherapy (ICACT). "We are encouraged with these results as well as with prior data showing that a weekly schedule of docetaxel demonstrates increased anti-tumor activity with less toxicity." Early results in 42 women with locally advanced breast cancer who received a combination of weekly docetaxel and doxorubicin demonstrated an overall response rate of 77 percent. All women enrolled in the trial had a histologic or cytologic diagnosis of inflammatory or locally advanced breast adenocarcinoma with measurable and/or evaluable disease and adequate functional status. Those who had undergone prior systemic therapy or radiotherapy for breast cancer were excluded. The median age of the study population was 54 years, and the median ECOG (Eastern Cooperative Oncology Group, a gage of functional status) status was 0. Sites of metastatic involvement included soft tissue in 74 percent of patients, liver in 31 percent, bone in 30 percent and lung in 20 percent. 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 1. After four cycles of chemotherapy, mammography was performed followed by surgery and/or radiotherapy. All patients were pre-medicated with three 8-mg doses of dexamethasone. 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 and vomiting, and stomatitis. There was no evidence of grade 4 non-hematologic toxicity. The docetaxel dose was reduced in seven of 40 treatment cycles in patients with operable breast cancer and in 19 of 105 cycles in patients with inoperable advanced or metastatic disease. Seventeen treatment cycles were postponed in women with operable disease, and 22 cycles were postponed in women with inoperable or advanced metastatic disease. 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, he added.
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