Treatment of patients resistant to anthracycline therapy

The results of three multicentre phase II trials in which docetaxel (Taxotere) was used in previously treated patients with metastatic breast cancer resistant to anthracyclines or anthracenediones are summarized here. Docetaxel was given to a total of 134 patients who had evidence of disease progression while receiving anthracyclines or anthracenediones for metastatic disease or had relapsed during adjuvant therapy which included these agents. The overall response rate (ORR) across the three studies was 41% in an intent-to-treat analysis. The median duration of response varied from 24 to 28 weeks between studies and the median survival varied from 9 to 12 months. The response rate was well maintained in evaluable patients with visceral metastases (ORR 43%), or multiple (> 2) sites of disease (ORR 48%). These response rates are the highest ever reported for a single agent in patients with anthracycline-resistant disease. The recommended dose and schedule for docetaxel (100 mg/m2 intravenously over 1-h every 3 weeks), which was used in all three studies, was found to be well tolerated, with neutropenia as the most common toxicity (grade 4 in 90% of patients) and febrile neutropenia requiring hospitalisation occurring in only 4% of cycles of therapy.