Gemcitabine combined with 5-fluorouracil and cisplatin (GFP) in patients with advanced biliary tree cancers: a pilot study.
BACKGROUND
Advanced biliary tree cancers have poor prognosis and chemotherapy has been shown to have little impact. To date, no standard chemotherapy regimens have been established. A pilot study to evaluate gemcitabine/5-Fluorouracil(5-FU)/cisplatin(CDDP) (GFP) chemotherapy in patients with advanced biliary tree cancers was performed.


METHODS
Eight patients with advanced intrahepatic cholangiocarcinoma and gallbladder carcinoma with no prior chemotherapy were treated with a 4-week cycle GFP chemotherapy consisting of gemcitabine at 1000 mg/m2 on days 1, 8, and 15, and of 5-FU at 250 mg/patient and CDDP at 5 mg/patient on days 1 to 5, 8 to 12 and 22 to 26.


RESULTS
Of these 8 patients, no complete responses (CR) were observed, but 3 patients (37.5%) demonstrated partial responses (PR) with an additional 3 patients (37.5%) having stable diseases (SD), as assessed by RECIST. Two patients with PR and 1 patient with SD were treated by curative operation after GFP chemotherapy and all of them survived with no recurrence. The median overall survival time was 23.5 months, and median time to progression was 14.5 months. Grade 3/4 side-effects, such as leukopenia, thrombocytepenia and anemia were found in 4 patients (50%), but no patients dropped out because of toxicity.


CONCLUSIONS
This GFP chemotherapy has promising antitumor activity and is well tolerated in patients with advanced biliary tree cancers. This regimen warrants further evaluation in a phase II study including larger numbers of patients.
Yamashita
Yo-ichi
Y
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. yamashi@surg2.med.kyushu-u.ac.jp
Taketomi
Akinobu
A
Fukuzawa
Kengo
K
Yoshizumi
Tomoharu
T
Uchiyama
Hideaki
H
Simada
Mitsuo
M
Shirabe
Ken
K
Wakasugi
Kenzo
K
Maehara
Yoshihiko
Y
D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005706:Gallbladder Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine