Objective: To assess the efficacy and safety profile of docetaxel, as a single agent, in the treatment of elderly patients with advanced breast cancer.
Methods: Twenty-eight patients, with a median age of 72 (range 66-84) years, were included in the study and received docetaxel (50-100 mg/m(2)) every 3-4 weeks as first- or second-line treatment of advanced breast cancer. Granulocyte colony-stimulating factor (G-CSF) was administered as primary prophylaxis in 97% of cycles.
Results: The overall response rate was 50% (95% CI 32, 69). The median time to disease progression was 10.7 months (95% CI 10.0, 11.5), and the median overall survival was 26.6 months (95% CI 16.6, 36.7). Neutropenia was the most frequent grade 3/4 toxicity (18% of patients and 5% of cycles). There was just one case of febrile neutropenia that resulted in toxic death. Severe neutropenia only occurred in patients who did not receive G-CSF support from the start of the study treatment. Vomiting was the most frequent grade 3/4 non-haematological toxicity (11% of patients and 2% of cycles).
Conclusion: Docetaxel as a single agent is active in elderly patients with advanced breast cancer. The use of prophylactic G-CSF allowed the administration of high doses of docetaxel with minimal myelosuppression.