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Phase II study of gemcitabine and cisplatin in advanced biliary tract cancer
Author(s) -
Park Byung Kyu,
Kim Yoon Jae,
Park Jeong Youp,
Bang Seungmin,
Park Seung Woo,
Chung Jae Bock,
Kim Kyung Sik,
Choi JinSub,
Lee Woo Jung,
Song Si Young
Publication year - 2006
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2006.04230.x
Subject(s) - medicine , gemcitabine , leukopenia , chemotherapy , regimen , cisplatin , gastroenterology , biliary tract , phases of clinical research , combination chemotherapy , vomiting , cancer , oncology , surgery
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.