Abstract | PURPOSE: METHODS: Patients with histologically or cytologically confirmed, measurable biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary cancer, who were not suitable candidates for surgery, were eligible for the study. Patients received oral UFT at 300 mg/m(2) per day divided into two doses on days 1-14 and intravenous doxorubicin at 30 mg/m(2) on day 1. This cycle was repeated every 21 days. The relationship between the patient characteristics and the prognosis was examined. Univariate and multivariate analyses were conducted to identify the prognostic factors associated with survival. RESULTS: Sixty-one patients from 12 institutions were enrolled in the late phase II study between April 2005 and March 2006. Of the 61 patients, 4 patients had partial responses, for an objective response rate of 6.6% (95% CI: 1.8-15.9%); 28 patients had stable disease, 27 had progressive diseases, and 2 patients were not evaluated. The median progression-free survival was 1.6 months, and the overall median survival time was 6.5 months. In the 85 patients who received this UFD chemotherapy in previous and late phase II studies, multivariate analysis revealed the ECOG performance status 1 (P = 0.001), gallbladder as the primary cancer site (P = 0.014), T-factor 4 of the TNM classification (P = 0.035), and elevated serum lactate dehydrogenase levels (P = 0.043) as being associated with a significantly shorter survival. CONCLUSIONS:
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Authors | Junji Furuse, Takuji Okusaka, Shinichi Ohkawa, Michitaka Nagase, Akihiro Funakoshi, Narikazu Boku, Kenji Yamao, Taketo Yamaguchi, Toshiya Sato |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 65
Issue 1
Pg. 113-20
(Dec 2009)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 19404641
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Tegafur
- Uracil
- Doxorubicin
- L-Lactate Dehydrogenase
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Topics |
- Aged
- Ampulla of Vater
(pathology)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Bile Duct Neoplasms
(diagnosis, drug therapy, mortality)
- Bile Ducts, Intrahepatic
(pathology)
- Biliary Tract Neoplasms
(diagnosis, drug therapy, mortality)
- Cholangiocarcinoma
(diagnosis, drug therapy, mortality)
- Common Bile Duct Neoplasms
(diagnosis, drug therapy, mortality)
- Disease-Free Survival
- Doxorubicin
(administration & dosage)
- Female
- Gallbladder Neoplasms
(diagnosis, drug therapy, mortality)
- Humans
- L-Lactate Dehydrogenase
(blood)
- Male
- Middle Aged
- Multivariate Analysis
- Neoplasm Staging
- Prognosis
- Survival Rate
- Tegafur
(administration & dosage)
- Treatment Outcome
- Uracil
(administration & dosage)
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