Capecitabine plus hepatic intra-arterial epirubicin and cisplatin in unresectable biliary cancer: a phase II study.
The aim of the present study was to evaluate the activity of hepatic intra-arterial infusion of epirubicin and cisplatin combined with oral capecitabine, in patients with unresectable biliary carcinomas.


METHODS
Twenty patients were treated by bolus infusion of epirubicin 50 mg/m2 and cisplatin 60 mg/m2 in the hepatic artery on day 1, combined with oral capecitabine 1000 mg/m2 bid, from day 2 to day 15.


RESULTS
Partial responses (PR) were observed in 6 patients (31.5%), stable disease (SD) in 9 (47.5%) and progression (PD) in 4 (21%). The median progression-free and overall survival periods were 11.6 and 18.0 months, respectively, and 1-year survival was 74%. One patient died after the first cycle because of G4 diarrhea. The other patients had good tolerance, with minimal hematological toxicity and only 1 G3 vomiting.


CONCLUSIONS
This combined intra-arterial and oral approach to patients with biliary carcinomas was found to be active and safe and seems to produce an encouraging survival response.
Mambrini
Andrea
A
Department of Oncology and 3Radiology, Carrara City Hospital, Carrara, Italy.
Guglielmi
Alfredo
A
Pacetti
Paola
P
Iacono
Calogero
C
Torri
Tito
T
Auci
Alessio
A
Nicoli
Nicola
N
Orlandi
Massimo
M
Guadagni
Stefano
S
Fiorentini
Giammaria
G
Cantore
Maurizio
M
D000230:Adenocarcinoma / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D018281:Cholangiocarcinoma / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged
D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil