Taxotere Combinations Show Promise in Advanced Breast Cancer

December 1, 1995

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

Combinations of the new agent, Taxotere (docetaxel), and Navelbine(vinorelbine), and Taxotere plus Adriamycin (doxorubicin) haveboth demonstrated activity in the treatment of metastatic breastcancer, according to research presented at the Eighth Annual EuropeanCancer Conference (ECCO-8).

In a Phase I study conducted at the Centre Régional deLutte Contre le Cancer (Regional Center for the Fight AgainstCancer) at the Centre René Gauducheau in Nantes, France,patients with metastatic breast cancer were treated with the combinationof docetaxel and vinorelbine.

"The preliminary results of this study show that the Taxotere-Navelbinecombination appears to be both active and well-tolerated in thesepatients," said Dr. Pierre Fumoleau of the Centre RenéGauducheau. "This finding encourages us to continue studiesof Taxotere in combination with Navelbine as well as other chemotherapydrugs."

Of 28 patients enrolled in the study, 23 had received previouschemotherapy for metastatic breast cancer. All treated patientswere premedicated with corticosteroids and a capillary protectorto reduce the possibility of adverse events caused by chemotherapy.All patients received a 1-hour intravenous infusion of docetaxelpreceded by a 20-minute bolus intravenous infusion of vinorelbine.

Of 25 evaluable patients, 10 had metastatic disease which couldbe measured. Of those, six patients had partial response and fourhad 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 anywithdrawn for fluid retention.

The Centre René Gauducheau, one of the French cancer centers,works in conjunction with the European Organization for Researchand Treatment of Cancer.

Docetaxel-Doxorubicin

The docetaxel-doxorubicin combination also demonstrated significantactivity and a well-tolerated safety profile in the first-linetreatment of metastatic breast cancer. This Phase I study wasconducted at the Institut Curie, in Paris, and Hôpital Paul-Broussein Villejuif, France.

"Our study is significant because it indicates that the combinationof Taxotere with doxorubicin is very active on an outpatient basisas first-line chemotherapy in metastatic breast cancer and iswell-tolerated," said Dr. Veronique Dieras of the InstitutCurie. The combination did not have any significant adverse effectson cardiac function, Dr. Dieras said.

Of the 35 patients enrolled in the study, 13 had not receivedprevious chemotherapy, 20 had received adjuvant therapy with anthracycline,and two had received adjuvant non-anthracycline-based chemotherapyat least 12 months prior to entering the study.