Abstract
BACKGROUND
The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as firstβline treatment for patients with locally advanced/metastatic breast carcinoma.
METHODS
This openβlabel, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m^2^ (intravenous bolus), and docetaxel, 75 mg/m^2^ (1βhour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m^2^ twice daily, on Days 1β14 of each 3βweek treatment cycle.
RESULTS
A total of 67 patients received 392 cycles of treatment, with a median of 6 cycles in patients with Stage III disease (n = 34 patients) and a median of 8 cycles in patients with Stage IV disease (n = 33 patients). The objective response rate was 82%, including complete responses in 21% of patients. A greater proportion of patients with Stage III disease achieved tumor responses compared with patients who had Stage IV disease (97% vs. 67%, respectively). Among 34 patients with Stage III disease, pathologic complete responses were confirmed in 10 patients (29%). TEX chemotherapy demonstrated an acceptable safety profile. There was a low incidence of Grade 3 adverse events, and Grade 4 adverse events were particularly rare (4%). The most common Grade 3β4 adverse event was febrile neutropenia, which occurred in 16% of patients.
CONCLUSIONS
TEX combination therapy has important antitumor activity and an acceptable safety profile in this setting. A large, randomized, Phase III trial is ongoing to compare TEX chemotherapy with an epirubicin plus docetaxel regimen in patients with untreated, advanced breast carcinoma. Cancer 2003;97:1174β80. Β© 2003 American Cancer Society.
DOI 10.1002/cncr.11203