Combinations of the new agent, Taxotere (docetaxel), and Navelbine (vinorelbine), and Taxotere plus Adriamycin (doxorubicin) have both demonstrated activity in the treatment of metastatic breast cancer, according to research presented at the Eighth Annual European Cancer Conference (ECCO-8).
In a Phase I study conducted at the Centre Régional de Lutte Contre le Cancer (Regional Center for the Fight Against Cancer) at the Centre René Gauducheau in Nantes, France, patients with metastatic breast cancer were treated with the combination of docetaxel(Drug information on docetaxel) and vinorelbine.
"The preliminary results of this study show that the Taxotere-Navelbine combination appears to be both active and well-tolerated in these patients," said Dr. Pierre Fumoleau of the Centre René Gauducheau. "This finding encourages us to continue studies of Taxotere in combination with Navelbine as well as other chemotherapy drugs."
Of 28 patients enrolled in the study, 23 had received previous chemotherapy for metastatic breast cancer. All treated patients were premedicated with corticosteroids and a capillary protector to reduce the possibility of adverse events caused by chemotherapy. All patients received a 1-hour intravenous infusion of docetaxel preceded by a 20-minute bolus intravenous infusion of vinorelbine.
Of 25 evaluable patients, 10 had metastatic disease which could be measured. Of those, six patients had partial response and four had no change. "We were pleased to see a decrease of 50% in tumor size...after only three to four cycles of treatment," said Dr. Fumoleau.
No patients experienced excessive fluid retention, nor were any withdrawn for fluid retention.
The Centre René Gauducheau, one of the French cancer centers, works in conjunction with the European Organization for Research and Treatment of Cancer.
The docetaxel-doxorubicin combination also demonstrated significant activity and a well-tolerated safety profile in the first-line treatment of metastatic breast cancer. This Phase I study was conducted at the Institut Curie, in Paris, and Hôpital Paul-Brousse in Villejuif, France.
"Our study is significant because it indicates that the combination of Taxotere with doxorubicin(Drug information on doxorubicin) is very active on an outpatient basis as first-line chemotherapy in metastatic breast cancer and is well-tolerated," said Dr. Veronique Dieras of the Institut Curie. The combination did not have any significant adverse effects on cardiac function, Dr. Dieras said.
Of the 35 patients enrolled in the study, 13 had not received previous chemotherapy, 20 had received adjuvant therapy with anthracycline, and two had received adjuvant non-anthracycline-based chemotherapy at least 12 months prior to entering the study.