Park Byung Kyu, Kim Yoon Jae, Park Jeong Youp, Bang Seungmin, Park Seung Woo, Chung Jae Bock, Kim Kyung Sik, Choi Jin-Sub, Lee Woo Jung, Song Si Young
Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul 120-752, Korea.
J Gastroenterol Hepatol. 2006 Jun;21(6):999-1003. doi: 10.1111/j.1440-1746.2006.04230.x.
The aim of this phase II study was to determine the efficacy of gemcitabine plus cisplatin chemotherapy in patients with advanced biliary tract cancer.
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.
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.
Gemcitabine and cisplatin combination chemotherapy is an effective, safe, and well-tolerated regimen for the treatment of advanced biliary tract cancer.
本II期研究的目的是确定吉西他滨联合顺铂化疗对晚期胆管癌患者的疗效。
入选标准包括组织学确诊的腺癌，胆管内有可测量的肿瘤，无法切除，且为局部晚期或转移性。患者接受吉西他滨（第1、8和15天静脉注射1000mg/m²）和顺铂（第1天静脉注射75mg/m²）联合治疗。每28天重复一个周期。根据世界卫生组织标准评估客观肿瘤反应率和毒性。
27例患者入组本研究，共进行了120个化疗周期。9例（33.3%）患者观察到客观部分缓解，7例（25.9%）患者病情稳定。中位生存时间为10.0个月，1年生存率为36%。疾病进展的中位时间为5.6个月。最常见的3-4级毒性反应为白细胞减少（25.9%）、贫血（29.6%）、血小板减少（22.2%）和呕吐（18.5%）。只有1例患者因化疗相关并发症住院。
吉西他滨和顺铂联合化疗是治疗晚期胆管癌的一种有效、安全且耐受性良好的方案。
