A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas

Ming Hsien Lin, Jen Shi Chen, Helen H.W Chen, Wu-Chou Su

Research output: Contribution to journalArticle

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Abstract

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/m2/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. Conclusion: Chemotherapy with gemcitabine demonstrated notable activity and was associated with a well-tolerable toxicity profile in patients with advanced biliary tract malignancies.

Original languageEnglish
Pages (from-to)154-158
Number of pages5
JournalChemotherapy
Volume49
Issue number3
DOIs
Publication statusPublished - 2003 Jun 30

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gemcitabine
Bile Ducts
Carcinoma
Therapeutics
Confidence Intervals
Disease-Free Survival
Survival
Biliary Tract

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Drug Discovery
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

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title = "A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas",
abstract = "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/m2/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. Conclusion: Chemotherapy with gemcitabine demonstrated notable activity and was associated with a well-tolerable toxicity profile in patients with advanced biliary tract malignancies.",
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A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas. / Lin, Ming Hsien; Chen, Jen Shi; Chen, Helen H.W; Su, Wu-Chou.

In: Chemotherapy, Vol. 49, No. 3, 30.06.2003, p. 154-158.

Research output: Contribution to journalArticle

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AB - 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/m2/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. Conclusion: Chemotherapy with gemcitabine demonstrated notable activity and was associated with a well-tolerable toxicity profile in patients with advanced biliary tract malignancies.

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