S-1 monotherapy in patients with advanced biliary tract cancer.
OBJECTIVE
The aim of this study was to evaluate the efficacy and safety of single-agent S-1 in patients with advanced biliary tract cancer.


METHODS
S-1 was administered orally at a dose of 80 mg/m2 for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal.


RESULTS
Forty-five patients were enrolled between January 2005 and June 2008. Among these, 29 patients received S-1 as first-line chemotherapy and 16 patients received S-1 as second-line chemotherapy. The response rates for first- and second-line chemotherapy were 17.2 and 18.8%, respectively. The median times to progression for the first- and second-line chemotherapy groups were 4.2 and 5.5 months (p = 0.91), respectively. The median overall survival and 1-year survival rate for each group were 8.7 and 8.0 months and 42.2 and 38.2%, respectively (p = 0.62). Only the first-line chemotherapy group experienced grade 3/4 toxicities, including leukopenia (6.9%), neutropenia (10.3%), anemia (6.9%), thrombocytopenia (10.3%) and total bilirubin elevation (3.4%).


CONCLUSIONS
S-1 monotherapy is a feasible and moderately efficacious treatment for advanced biliary tract cancer, as a first- or second-line chemotherapy regimen.
Sasaki
Takashi
T
Department of Gastroenterology, Faculty of Medicine, University of Tokyo, Tokyo, Japan. sasakit-tky@umin.ac.jp
Isayama
Hiroyuki
H
Yashima
Yoko
Y
Yagioka
Hiroshi
H
Kogure
Hirofumi
H
Arizumi
Toshihiko
T
Togawa
Osamu
O
Matsubara
Saburo
S
Ito
Yukiko
Y
Nakai
Yousuke
Y
Sasahira
Naoki
N
Hirano
Kenji
K
Tsujino
Takeshi
T
Tada
Minoru
M
Kawabe
Takao
T
Omata
Masao
M
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy*; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid