[A pilot study of weekly versus 3-week docetaxel in combination with capecitabine in patients with anthracycline-pretreated metastatic breast cancer].
OBJECTIVE
To evaluate the efficacy and safety of weekly or 3-week docetaxel in combination with capecitabine.


METHODS
83 Patients with at least one measurable lesion were randomized to receive the treatment arms: docetaxel 37.5 mg/m(2) on days 1 and 8, oral capecitabine 950 mg/m(2) twice daily on days 1-14 (Group A); docetaxel 75 mg/m(2) on days 1, oral capecitabine 950 mg/m(2) twice daily on days 1-14 (Group B). Each cycle was repeated every 3 weeks.


RESULTS
Eighty-three patients were enrolled, 78 eligible for tumor assessment. The overall clinical response rate of all groups was 61.4% (51/83). There was no progressive disease (PD) after two cycles. Efficacy outcomes were similar in the two groups. The response rate of group A and B were 61.8% (21/34) and 61.2% (30/49) respectively. There were no drug-related deaths observed. Neutropenia was the most common toxicity. In all, the frequency of Grade 3/4 neutropenia were 45.8% (38/83), but Grade 3/4 neutropenia of Group B 55.1% (27/49) was higher than Group A 32.4% (11/34), P = 0.04.


CONCLUSIONS
The study confirmed the superior activity of docetaxe-capecitabine combination therapy in anthracycline resistant MBC, and comparing with 3-week schedule, weekly docetaxel plus capecitabine has same high efficacy with a favourable safety profile.
Zhang
Shao-hua
SH
Clinical Cancer Centre Hospital No. 307, Beijing 100071, China.
Jiang
Ze-fei
ZF
Xie
Xiao-dong
XD
Wei
Yan
Y
Ren
Jun
J
Liu
Ji-wei
JW
Liu
Wen-chao
WC
Li
Xia
X
Bai
Yu-xian
YX
Jiao
Shun-chang
SC
Sun
Qiang
Q
Liu
Duan-qi
DQ
Xiao
Ju-xiang
JX
Wang
Hua-qing
HQ
Tang
Li-li
LL
Cheng
Ying
Y
Wang
Yu
Y
Wang
Yong-sheng
YS
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010865:Pilot Projects; D043823:Taxoids / Q000008:administration & dosage; D017211:Treatment Failure; D016896:Treatment Outcome
D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil