TEXAS (Taxotere EXperience with Anthracyclines Study) trial: mature results of activity/toxicity of docetaxel given with anthracyclines in a community setting, as first line therapy for MBC.

Abstract

PURPOSE: The TEXAS (Taxotere EXperience with Anthracyclines Study) study examined docetaxel in combination with an anthracycline, as first line treatment of metastatic breast cancer (MBC), in everyday practice, and compared the findings with a randomised controlled trial. METHODS: Four hundred and seventy patients were registered on the TEXAS trial. Patients were assigned, according to treating clinician's discretion, to either doxorubicin 50 mg/m2 or epirubicin 75 mg/m2 both given day1 15 min intravenous bolus every 3 weeks, followed by docetaxel 75 mg/m2, day 1, 1 h intravenous infusion every 3 weeks. RESULTS: The overall response rate (ORR) was approximately 61%. The main toxicity reported was neutropenia, with 75 patients (55%) in the AT group and 203 (61%) in the ET arm. Febrile neutropenia or neutropenic sepsis was reported for 32 (24%) of the AT arm and 78 (23%) of the ET arm. CONCLUSIONS: This open access study demonstrates that AT or ET are highly active treatments for MBC, with similar response rates to those observed in a phase III clinical trial. This may be important for patients with rapidly progressive visceral disease. Side effects can be managed effectively with growth factors and/or prophylactic antibiotic.