Phase II study of docetaxel, capecitabine, and cisplatin as neoadjuvant chemotherapy for locally advanced breast cancer.
OBJECTIVE
Docetaxel, capecitabine, and cisplatin are effective chemotherapeutic agents for breast cancer with significant synergistic cytotoxicity demonstrated by in vitro studies. The purpose of this study was to assess the efficacy of a combination of docetaxel, capecitabine, and cisplatin (TXP) in patients diagnosed with locally advanced breast cancer (LABC).


METHODS
Patients (n = 42) with chemotherapy-naïve LABC (stage IIIa or IIIb) were enrolled. The chemotherapeutic regimen consisted of 4-6 cycles of intravenous docetaxel (60 mg/m(2)) and cisplatin (50 mg/m(2)) on day 1, plus oral capecitabine (1,800 mg/m(2)/day) on day 1-14, repeated every 3 weeks. Upon completion of therapy, the primary tumor was resected when not contraindicated.


RESULTS
Median patient age was 48.5 years (range 31-66 years). Median tumor size was 6.8 cm (range 2.7-15 cm), 29 patients were node-positive, and 12 patients were hormone receptor positive. A total of 216 cycles (median 5; range 3-6 cycles) were administered without prophylactic G-CSF. The predominant toxicities were grade 3/4 neutropenia (30%/28%) and no grade 3/4 thrombocytopenia, febrile neutropenia, or grade 4 non-hematological toxicities were observed. Grade 3 non-hematological toxicities included hand-foot syndrome (5.6%) and vomiting (0.5%). The overall clinical response rate was 97.6% (41/42). Six of the 42 patients (14.3%) achieved a complete pathological response. Of 22 patients who completed 6 cycles of combination treatment, the complete pathological response was 27.3% (6/22).


CONCLUSIONS
A combination of TXP can be administered safely without prophylactic G-CSF, and appears to be an effective neoadjuvant regimen in patients with LABC.
Lu
Yen-Shen
YS
Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, ROC. yslu@ntu.edu.tw
Chen
Dar-Ren
DR
Tseng
Ling-Min
LM
Yeh
Dah-Cherng
DC
Chen
Shou-Tung
ST
Hsieh
Chia-Ming
CM
Wang
Hwei-Chung
HC
Yeh
Hsien-Tang
HT
Kuo
Sung-Hsin
SH
Huang
Chiun-Sheng
CS
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; 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; D020360:Neoadjuvant Therapy; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil