Phase II trial of gemcitabine combined with 5-fluorouracil and cisplatin (GFP) chemotherapy in patients with advanced biliary tree cancers.
OBJECTIVE
Advanced biliary tree cancers are often diagnosed at an advanced or metastatic stage and have poor prognoses. We reported the promising anti-tumor activity of gemcitabine/5-fluorouracil (5-FU)/cisplatin (CDDP) therapy, called 'GFP chemotherapy' in a pilot study.


METHODS
Twenty-one patients with advanced or metastatic biliary tree cancers with no prior chemotherapy were enrolled in this Phase II trial. Patients were treated on 4-week cycle GFP chemotherapy consisting of gemcitabine at 1000 mg/m(2) on days 1, 8 and 15, and 5-FU at 150 mg/m(2) and CDDP at 3 mg/m(2) on days 1-5, 8-12 and 15-19. After two cycles, a 4-week outpatient treatment of gemcitabine (1000 mg/m(2)) on days 1 and 15 combined with 5-FU (500 mg/m(2)) and CDDP (7 mg/m(2)) on days 1 and 15 was commenced. Treatment was repeated until tumor progression or remission allowing curative operation, or unacceptable toxicity occurred.


RESULTS
Of these 21 patients, no complete responses were observed, but 7 patients (33.3%) demonstrated partial responses (PRs) with an additional 12 patients (57.2%) having stable diseases, as assessed by RECIST. Three patients with PRs were treated by curative operation after GFP chemotherapy, and all of them survived with no recurrence for over 3 years. The median overall survival time was 18.8 months, and median time to progression was 13.4 months. Grade 3 side effects such as leukopenia, thrombocytopenia and anemia were found in six patients (28.6%), but no patients dropped out because of toxicity.


CONCLUSIONS
This GFP chemotherapy has promising anti-tumor activity and is well tolerated in patients with advanced biliary tree cancers.
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
Itoh
Shinji
S
Harimoto
Norifumi
N
Tsujita
Eiji
E
Sugimachi
Keishi
K
Gion
Tomonobu
T
Maehara
Yoshihiko
Y
D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000633:toxicity; D000971:Antineoplastic Combined Chemotherapy Protocols; D001650:Bile Duct Neoplasms / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000633:toxicity; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000633:toxicity; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine