Phase II study of epirubicin, cisplatin, and capecitabine for advanced biliary tract adenocarcinoma.
BACKGROUND
Advanced biliary tract carcinomas (BTCs) are associated with a very poor prognosis. New therapeutic strategies therefore are needed to improve efficacy and survival, and the current study was designed with a new, effective drug combination.


METHODS
Patients with recurrent or metastatic BTC received a combination of epirubicin at a dose of 50 mg/m(2), cisplatin at a dose of 60 mg/m(2) on Day 1, and capecitabine at a dose of 1000 mg/m(2) twice daily for 2 weeks. Treatment was repeated every 3 weeks.


RESULTS
A total of 43 patients (22 with extrahepatic cholangiocarcinoma, 15 with intrahepatic cholangiocarcinoma, and 6 with gallbladder carcinoma) were treated. The median age was 53 years (range, 36-69 yrs) and 5 patients had a Zubrod performance status of 2. Seventeen patients achieved a partial response (40%; 95% confidence interval [95% CI], 21-49%) and 10 had stable disease. With a follow-up duration of 18 months, the median survival time was 8 months (95% CI, 6-10 mos). In total, 187 chemotherapy cycles were delivered, with a median of 5 cycles per patient (range, 1-9 cycles). Toxicity was mainly myelosuppression and mucositis, but no patients died of toxicity.


CONCLUSIONS
This combination chemotherapy with epirubicin, cisplatin, and capecitabine offered promising antitumor activity in patients with advanced BTC.
Park
Se Hoon
SH
Division of Hematology and Oncology, Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, Korea.
Park
Yeon Ho
YH
Lee
Jeong Nam
JN
Bang
Soo-Mee
SM
Cho
Eun Kyung
EK
Shin
Dong Bok
DB
Lee
Jae Hoon
JH
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil