Abstract | PURPOSE: This phase II study was conducted to evaluate the efficacy and toxicity of single-agent gemcitabine in patients with advanced or metastatic biliary tract cancer. PATIENTS AND METHODS:
Gemcitabine 1,000 mg/m(2) was administered as an intravenous 30-min infusion on days 1, 8, and 15 for every 28 days. RESULTS: Forty chemonaive patients with a median age of 61 (range 33-73) were enrolled, and all 40 patients were involved in efficacy and safety analyses. Seven (17.5%) achieved partial response; 15 (37.5%) had stable disease; 17 (42.5%) had progressive disease; and 1 (2.5%) was not evaluated. The median survival time was 7.6 months, and the 1-year survival rate was 25.0%. Grade 3/4 neutropenia occurred in 12 patients (30.0%), leukopenia in five patients (12.5%), and anemia in four patients (10.0%). The most common grade 3/4 nonhematologic toxicities were elevated ALT (15.0%) and elevated gamma- GTP (12.5%). One patient had grade 4 hemolytic uremic syndrome and recovered after discontinuation of gemcitabine. CONCLUSIONS:
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Authors | Takuji Okusaka, Hiroshi Ishii, Akihiro Funakoshi, Kenji Yamao, Shinichi Ohkawa, Soh Saito, Hiroshi Saito, Toshio Tsuyuguchi |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 57
Issue 5
Pg. 647-53
(May 2006)
ISSN: 0344-5704 [Print] Germany |
PMID | 16142487
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antimetabolites, Antineoplastic
- Deoxycytidine
- Ribonucleotide Reductases
- Gemcitabine
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Topics |
- Adenocarcinoma
(drug therapy, mortality, secondary)
- Adult
- Aged
- Antimetabolites, Antineoplastic
(therapeutic use)
- Biliary Tract Neoplasms
(drug therapy, mortality, pathology)
- Deoxycytidine
(analogs & derivatives, therapeutic use)
- Female
- Humans
- Male
- Maximum Tolerated Dose
- Middle Aged
- Ribonucleotide Reductases
(antagonists & inhibitors)
- Survival Rate
- Gemcitabine
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