Treatment efficacy/safety and prognostic factors in patients with advanced biliary tract cancer receiving gemcitabine monotherapy: an analysis of 100 cases.
OBJECTIVE
The purpose of this study was to elucidate the treatment efficacy and safety of gemcitabine monotherapy, and to identify prognostic factors in patients with advanced biliary tract cancer receiving this therapy.


METHODS
The data of 100 patients with advanced biliary tract cancer who were treated with gemcitabine as first-line chemotherapy were reviewed retrospectively.


RESULTS
One patient showed complete response (1.0%) and 6 patients showed partial response (6.0%), yielding an overall response rate of 7.0%. The main grade 3/4 toxicities were neutropenia and leukopenia. The median survival, 1-year survival rate and progression-free survival were 7.3 months, 21.6% and 3.1 months, respectively. Multivariate analysis identified a performance status of 0-1, serum C-reactive protein level of <3.0 mg/dl, serum carcinoembryonic antigen level of <10 ng/ml and serum albumin level of ≥ 3.5 g/dl as factors independently associated with a favorable prognosis.


CONCLUSIONS
Gemcitabine monotherapy showed modest efficacy with manageable toxicity in patients with biliary tract cancer. These results could be useful as reference data for optimizing treatment strategies and planning future clinical trials in patients with advanced biliary tract cancer.
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan. eisuzuki@ks.kyorin-u.ac.jp
Eiichiro
E
Suzuki
Junji
J
Furuse
Masafumi
M
Ikeda
Takuji
T
Okusaka
Kohei
K
Nakachi
Shuichi
S
Mitsunaga
Hideki
H
Ueno
Chigusa
C
Morizane
Shunsuke
S
Kondo
Satoshi
S
Shimizu
Yasushi
Y
Kojima
Atsushi
A
Hagihara
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014408:Biomarkers, Tumor / Q000097:blood*; D002097:C-Reactive Protein / Q000378:metabolism; D002272:Carcinoembryonic Antigen / Q000097:blood; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011379:Prognosis; D012189:Retrospective Studies; D012709:Serum Albumin / Q000378:metabolism; D016896:Treatment Outcome; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D014408:Biomarkers, Tumor; D002272:Carcinoembryonic Antigen; D012709:Serum Albumin; D003841:Deoxycytidine; D002097:C-Reactive Protein; D000093542:Gemcitabine