Phase II study of gemcitabine and cisplatin in advanced biliary tract cancer
Authors
Byung Kyu Park ; Yoon Jae Kim ; Jeong Youp Park ; Seungmin Bang ; Seung Woo Park ; Jae Bock Chung ; Kyung Sik Kim ; Jin-Sub Choi ; Woo Jung Lee ; Si Young Song
Citation
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.21(6) : 999-1003, 2006
biliary tract cancer ; chemotherapy ; cisplatin ; gemcitabine
Abstract
BACKGROUND: The aim of this phase II study was to determine the efficacy of gemcitabine plus cisplatin chemotherapy in patients with advanced biliary tract cancer.
METHODS: Eligibility criteria included histologically confirmed adenocarcinoma with measurable tumor in the biliary tract that was unresectable and either locally advanced or metastatic. Patients received a combination of gemcitabine (1000 mg/m(2) intravenously [IV] on days 1, 8, and 15) and cisplatin (75 mg/m(2) IV on day 1). Cycles were repeated every 28 days. Objective tumor response rates and toxicities were evaluated according to World Health Organization criteria.
RESULTS: Twenty-seven patients were enrolled in the study and a total of 120 cycles of chemotherapy were administrated. Objective partial response was observed in nine (33.3%) patients, while stable disease was found in seven (25.9%) patients. The median survival time was 10.0 months and the 1-year survival rate was 36%. Median time to disease progression was 5.6 months. The most common grade 3-4 toxicities were leukopenia (25.9%), anemia (29.6%), thrombocytopenia (22.2%), and vomiting (18.5%). Only one patient was hospitalized for chemotherapy-related complications.
CONCLUSION: Gemcitabine and cisplatin combination chemotherapy is an effective, safe, and well-tolerated regimen for the treatment of advanced biliary tract cancer.