The objective of this study was to assess the response rate and the
toxicity of the combination docetaxel (Taxotere)/vinorelbine
(Navelbine) in patients with advanced breast cancer.
Ninety-six patients, with a median age of 55 years (range: 2677
years), were included. All patients had metastatic breast carcinoma
and had received an anthracycline-containing regimen to treat
advanced disease. Therapy consisted of docetaxel at 75 mg/m² on
day 1 and vinorelbine at 20 mg/m² on days 1 and 5, every 21
days. Courses were repeated every 21 days. The dose of both drugs was
reduced by 25% in the case of previous delays due to toxicity.
Granulocyte colony-stimulating factor (G-CSF) was allowed in the case
of previous grade 4 neutropenia or febrile neutropenia. An evaluation
was performed after three courses and therapy was continued up to six
courses, unless progression or intolerable toxicity occurred.
The Eastern Cooperative Oncology Group (ECOG) performance status was
0 in 36% of the patients, 1 in 54%, and 2 in 10%. The main metastatic
sites were liver (46% of patients) and lung (42%); nearly half of the
patients had more than one metastatic location. A total of 511
courses were given, with a median of 6 per patient (range: 16).
There were 13 complete responses and 51 partial responses, for an
overall response rate of 70% (95% CI: 59%79%). Grade 34
toxicity was as follows: neutropenia 24% of patients, febrile
neutropenia 15%, alopecia 60%, and stomatitis 16%. After a median
follow-up of 230 days, disease-free and overall survival were 269
days (95% CI: 219287 days) and 420 days (95% CI: 321517
CONCLUSION: The combination of docetaxel/vinorelbine is highly active
in patients with metastatic breast carcinoma who were previously
treated with an anthracycline-containing regimen.