The objective of this study was to assess the response rate and the toxicity of the combination docetaxel(Drug information on 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 days), respectively.
CONCLUSION: The combination of docetaxel/vinorelbine is highly active in patients with metastatic breast carcinoma who were previously treated with an anthracycline-containing regimen.