TY - JOUR
T1 - Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma
AU - Venturini, Marco
AU - Durando, Antonio
AU - Garrone, Ornella
AU - Colozza, Maria Antonietta
AU - Contu, Antonio
AU - Stevani, Ilaria
AU - Genta, Franco
AU - Bighin, Claudia
AU - Lambiase, Antonio
AU - Del Mastro, Lucia
PY - 2003/3/1
Y1 - 2003/3/1
N2 - BACKGROUND. The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma. METHODS. This open-label, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m2 (intravenous bolus), and docetaxel, 75 mg/m2 (1-hour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m2 twice daily, on Days 1-14 of each 3-week 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 3-4 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.
AB - BACKGROUND. The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma. METHODS. This open-label, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m2 (intravenous bolus), and docetaxel, 75 mg/m2 (1-hour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m2 twice daily, on Days 1-14 of each 3-week 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 3-4 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.
KW - Advanced breast carcinoma
KW - Capecitabine
KW - Docetaxel
KW - Epirubicin
KW - Phase II
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U2 - 10.1002/cncr.11203
DO - 10.1002/cncr.11203
M3 - Article
C2 - 12599222
AN - SCOPUS:0345505673
VL - 97
SP - 1174
EP - 1180
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 5
ER -