Background: Previous phase II studies of docetaxel have indicated that hepatic metastases from breast cancer respond well to first-line treatment with docetaxel. The objective of this prospective, open label phase II study therefore was specifically to evaluate the activity and safety of docetaxel in this indication.
Patients and methods: The study recruited 47 women (mean age 50 years, range 33-66 years) with hepatic metastases from breast cancer who fulfilled the eligibility criteria. After premedication with steroids, patients received a one-hour intravenous infusion of docetaxel 100 mg/m2 at three-weekly intervals for up to eight cycles. Response to treatment during medication was assessed after three, six and where appropriate, eight cycles and every three month follow-up thereafter, until disease progression or death.
Results: The best overall response rate (ORR) for evaluable patients was 64.3% (95% CI: 48.0-78.5%). In terms of the primary efficacy parameters, the ORR at the sixth cycle of treatment was 62% (95% CI: 45%-80%) with 17% complete responses. The median duration of response was 139 days (95% CI: 111-216 days) and the median survival duration calculated on an intent-to-treat basis was 335 days (227-568 days, 95% CI). One (2%) toxic death was reported.
Conclusions: Docetaxel is a highly effective cytotoxic agent in the treatment of patients with liver metastases from breast cancer.