Weekly gemcitabine for the treatment of biliary tract and gallbladder cancer.
OBJECTIVE
To evaluate the efficacy and safety of weekly administration of gemcitabine treatment in chemotherapy-naïve patients with advanced biliary tract and gallbladder cancer.


METHODS
Gemcitabine at a dose of 800 mg/m2 was administered weekly as a 30-min infusion to patients with previously operated, histologically confirmed, metastatic, or unresectable locally advanced cholangiocarcinoma. Treatment was continued until unacceptable toxicity or disease progression.


RESULTS
A total of 30 patients (median age 66 years; range 54-72 years) were included in the study. A median of 14 (range, 4-33) weekly doses was administered. Out of 30 patients evaluable for response, nine partial responses were observed (30.0%), while a further 11 patients demonstrated stable disease (36.7%). The median time to disease progression was 7 months (range, 5-34). Overall response rate was superior in patients with cancer of the gallbladder (ORR = 35.7%) compared with those patients with biliary duct cancer (ORR = 27.3%). This correlated to a significantly longer time to progression of 6.4 months (95% confidence interval (CI), 5.6-7.1 months) versus 3.6 months (95% CI, 2.9-4.3 months; p = 0.03) and a significantly better overall survival of 17.1 months (95% CI, 15.8-18.5 months) versus 11.4 months (95% CI, 10.2-12.6 months, p = 0.021). Toxicities were generally mild with only one case of grade 3 neutropenia. There were no cases of febrile neutropenia and no treatment-related deaths.


CONCLUSIONS
Weekly administration of gemcitabine provides a safe, well-tolerated, and effective treatment for chemotherapy naïve patients with advanced cholangiocarcinoma, particularly with a gallbladder origin.
Tsavaris
Nikolas
N
Hellenic Group of Oncology, Athens, Greece.
Kosmas
Christos
C
Gouveris
Panagiotis
P
Gennatas
Kostadinos
K
Polyzos
Aris
A
Mouratidou
Despina
D
Tsipras
Heracles
H
Margaris
Helias
H
Papastratis
George
G
Tzima
Evanthia
E
Papadoniou
Nikitas
N
Karatzas
Gavrilos
G
Papalambros
Efstathios
E
D000368:Aged; D001661:Biliary Tract Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D018281:Cholangiocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D016001:Confidence Intervals; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005706:Gallbladder Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D006402:Hematologic Diseases / Q000097:blood / Q000139:chemically induced; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D000093542:Gemcitabine
D003841:Deoxycytidine; D000093542:Gemcitabine