Regional combined with systemic chemotherapy in unresectable biliary tract cancers: a phase II study.
Unresectable biliary tract cancers have a very poor prognosis. No good systemic chemotherapeutic regimen is available. This study aimed to evaluated the activity and toxicity of a novel approach of combined loco-regional and systemic chemotherapy. Twenty four patients with advanced or metastatic biliary tumors were treated with epiadriamycin 50 mg/m2 and cisplatin 60 mg/m2 administered bolus in proper hepatic artery on day 1, combined with systemic continuous infusion of 5-fluorouracil 200 mg/m2/day, from day 1 to day 14, every 3 weeks. The overall response rate was 8/24 (33%), including one complete response and 7 partial responses (stable disease 46%, progression 21%). The treatment was well tolerated with a minimal hematological toxicity; the major clinical problem was the deep venous thrombosis related to central venous catheter, that occurred in 5 patients (21%). Median overall survival was 14,6 months and 1-year and 2-year survival were 54% and 38% respectively. Performance status improved in 33% of patients and weight gain more than 7% was observed in 17%. This novel combined loco-regional and systemic chemotherapeutic regimen is active and safe for advanced biliary tract cancer patients.
Cantore
M
M
Oncological Department, USL 1 Massa e Carrara, Empoli. mauriziocantore@hotmail.com
Fiorentini
G
G
Mambrini
A
A
Rabbi
C
C
Zamagni
D
D
Carlone
N
N
Manni
A
A
Caudana
R
R
Torri
T
T
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002408:Catheters, Indwelling / Q000009:adverse effects; D010478:Chemotherapy, Cancer, Regional Perfusion; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007269:Injections, Intra-Arterial; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000139:chemically induced
D000970:Antineoplastic Agents; D004317:Doxorubicin; D002945:Cisplatin; D005472:Fluorouracil