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 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
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withdrawn for fluid retention.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 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.