A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas.
BACKGROUND
Gemcitabine is a novel nucleoside analogue with clinical anticancer activity in several malignancies. From September 1998 to April 2000, we treated patients with advanced bile duct and periampullary carcinomas with gemcitabine alone.


METHODS
Gemcitabine 1,000 mg/m(2)/day was administered in 200 ml of normal saline as a 30-min intravenous infusion on day 1 weekly for 3 weeks, followed by a 1-week rest.


RESULTS
A total of 24 consecutive patients (15 men, 9 women), with a median age of 59.5 years (range 40-72 years), were enrolled. All patients were evaluable for response: 1 patient achieved complete remission (CR); 2 patients had partial remission (PR); 8 patients remained stable (SD), and 13 patients had progressive disease (PD). The overall response rate (CR + PR) was 12.5% with a 95% confidence interval (CI) of 2.7-32.4%. The median progression-free survival (PFS) was 2.5 months (95% CI 1.6-5.5 months), and the median overall survival (OS) was 7.2 months (95% CI 3.8-8.9 months). Patients with disease control (CR + PR + SD) had better PFS and OS than those with PD. There were no treatment-related deaths. Few patients encountered grade 3/4 toxicity.


CONCLUSIONS
Chemotherapy with gemcitabine demonstrated notable activity and was associated with a well-tolerable toxicity profile in patients with advanced biliary tract malignancies.
Lin
Ming-Hsien
MH
Division of Hematology/Oncology, Department of Internal Medicine, College of Medicine, National Cheng Kung University Hospital, Tainan, Taiwan, ROC.
Chen
Jen-Shi
JS
Chen
Helen H-W
HH
Su
Wu-Chou
WC
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D003138:Common Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D016896:Treatment Outcome; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine