A multicentre phase II pilot study of epirubicin and Taxol (TM) (paclitaxel) in patients with advanced breast cancer

Anthracyclines are the gold standard monotherapy for metastatic breast canc er. Higher response rates are seen with drug combinations, especially with newer agents such as taxanes. The purpose of this study was to evaluate the toxicity and activity of the combination of paclitaxel and epirubicin in p atients with advanced breast cancer. Thirty-five women with locally advance d or metastatic breast cancer (first and second relapse) were treated with epirubicin 75 mg/m(2) and paclitaxel 200 mg/m(2) 3-weekly. Six centres recr uited 35 patients; 34 (97%) were assessable for response. Eighteen had unde rgone prior chemotherapy, including six (17%) with anthracycline-containing regimens. Grade 4 neutropenia was found in 33 patients (94%), which was of 4 days' av erage duration; however, infective complications were rare, with only nine cycles (6%) complicated by neutropenic sepsis, There were two sepsis-relate d deaths. Symptomatic cardiotoxicity was infrequent, although a >15% declin e in cardiac function was recorded in five patients (14%). Grade 3 peripher al neuropathy occurred in three patients (9%). The overall response rate wa s 50% (95% confidence interval 33-67) (complete response 12%; partial respo nse 38%), with a median duration of response of 31 weeks. The median time t o progression was 27 weeks, with a median survival of 48 weeks. This regimen appears to be a relatively safe, tolerable and effective treat ment for advanced breast cancer. A United Kingdom Co-ordinating Committee f or Cancer Research Phase III trial (AB-OI) comparing this combination of ep irubicin and paclitaxel with cyclophosphamide and paclitaxel completed accr ual in November 1999.