Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.
Oncology. 2010;79(1-2):39-45. doi: 10.1159/000318020. Epub 2010 Nov 10.
The purpose of this study was to elucidate the treatment efficacy and safety of gemcitabine monotherapy, and to identify prognostic factors in patients with advanced biliary tract cancer receiving this therapy.
The data of 100 patients with advanced biliary tract cancer who were treated with gemcitabine as first-line chemotherapy were reviewed retrospectively.
One patient showed complete response (1.0%) and 6 patients showed partial response (6.0%), yielding an overall response rate of 7.0%. The main grade 3/4 toxicities were neutropenia and leukopenia. The median survival, 1-year survival rate and progression-free survival were 7.3 months, 21.6% and 3.1 months, respectively. Multivariate analysis identified a performance status of 0-1, serum C-reactive protein level of <3.0 mg/dl, serum carcinoembryonic antigen level of <10 ng/ml and serum albumin level of ≥ 3.5 g/dl as factors independently associated with a favorable prognosis.
Gemcitabine monotherapy showed modest efficacy with manageable toxicity in patients with biliary tract cancer. These results could be useful as reference data for optimizing treatment strategies and planning future clinical trials in patients with advanced biliary tract cancer.
本研究旨在阐明吉西他滨单药治疗晚期胆道癌的疗效和安全性，并确定接受该治疗的患者的预后因素。
回顾性分析了 100 例接受吉西他滨一线化疗的晚期胆道癌患者的数据。
1 例患者完全缓解（1.0%），6 例患者部分缓解（6.0%），总缓解率为 7.0%。主要的 3/4 级毒性是中性粒细胞减少和白细胞减少。中位生存期、1 年生存率和无进展生存期分别为 7.3 个月、21.6%和 3.1 个月。多因素分析显示，体能状态 0-1、血清 C 反应蛋白水平<3.0mg/dl、血清癌胚抗原水平<10ng/ml 和血清白蛋白水平≥3.5g/dl 是与预后良好相关的独立因素。
吉西他滨单药治疗胆道癌具有一定的疗效，毒性可耐受。这些结果可作为优化晚期胆道癌患者治疗策略和计划未来临床试验的参考数据。
