[Phase II study of docetaxel plus epirubicin versus docetaxel plus cisplatin as first-line chemotherapy for advanced breast cancer].
OBJECTIVE
To evaluate the efficacy and safety of combination of docetaxel plus epirubicin (TE) versus docetaxel plus cisplatin (TP) as first-line chemotherapy for locally advanced or metastatic breast cancer.


METHODS
Eighty-eight patients were randomized into two groups with a ratio of 2:1, either to receive TE or TP regimen. The patients received docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 (TE group) or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 (TP group) administrated intravenously. Both regimens were once repeated 3 weeks later. The efficacy, time to progression and safety were evaluated at the end of the second cycle.


RESULTS
Complete response was achieved in 5% of TE group and 3.6% of TP. Overall (complete plus partial) response rates in TE and TP group were 48.3% and 60.7%, respectively (P = 0.2788). Disease control rates (CR + PR + SD) for TE and TP groups were 83.6% and 80%, respectively (P = 0.4899). The median time to progression (TTP) was 10 months for TE versus 8 months for TP groups (P = 0.7119). The major grade III or IV toxicities were neutropenia (66.7% in TE; 53.6% in TP, P = 0.2373); and alopecia (30.0% in TE; 10.7% in TP, P = 0.0508).


CONCLUSIONS
Both TE and TP regimens as first-line chemotherapy were similarly effective, safe and tolerable in the treatment for locally advanced or metastatic breast cancer.
Wang
Ya-Jie
YJ
Department of Oncology, Changhai Hospital, The Second Military Medical University, Shanghai 200433, China. yajiewa0459@163.com
Wu
Qing
Q
Su
Feng-Xi
FX
Zhou
Li-Zhong
LZ
Ye
Zheng-Bao
ZB
Yang
Jing-Qiao
JQ
Ren
Hong
H
Zhang
Jin
J
Ding
Gang
G
Fu
Qiang
Q
Wang
Ning
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D002945:Cisplatin