Chen Jen-Shi, Chao Yee, Yang Tseng-Sheng, Chou Wen-Chi, Chen Li-Tzong, Lee Kuan-Der, Lin Yang-Chung
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital , Chang Gung University College of Medicine, 199 Dung-Hwa North Road, Taipei, Taiwan.
Cancer Chemother Pharmacol. 2009 Dec;65(1):151-7. doi: 10.1007/s00280-009-1018-5. Epub 2009 May 20.
Advanced biliary tract carcinoma (BTC) is a dismal disease with no standard chemotherapy. We investigated efficacy and toxicity of biweekly oxaliplatin with 48-h infusion of 5-FU/LV in advanced BTC.
All patients had histologic confirmation of BTC, at least one measurable site of disease, and had received no prior chemotherapy. Patients were older than 20 years with ECOG performance scores (PS) of 0-2. Treatment involved 2-h infusion of oxaliplatin (85 mg/m(2)) diluted in D5W 500 ml followed by 48-h infusion of 5-FU (3,000 mg/m(2)) and LV (100 mg/m(2)) biweekly. Response evaluation was based on RECIST criteria and was carried out every two courses of treatment; toxicity evaluation was based on NCI common toxicity criteria version 3.0.
From August 2005 to December 2006, 34 chemotherapy-naive patients with advanced BTC were enrolled and 32 intention-to-treat patients were evaluated. Partial response was 18.8%, stable disease was 31.3%, resulting in a disease control rate of 50.0%. Median time to progression and survival was 3.7 and 7 months, respectively. The most common grade 3/4 toxicities were neutropenia 15.6% (5/32), stomatitis 9.4% (3/32), thrombocytopenia 6.3% (2/32), diarrhea 6.3% (2/32) and neuropathy 3.1% (1/32). No treatment-related deaths occurred.
The biweekly OXA and 48-h infusion of 5-FU/LV in patients with advanced BTC showed tolerable and efficacy equivalent to other combination regimens treatment.
晚期胆管癌（BTC）是一种预后不佳的疾病，尚无标准的化疗方案。我们研究了每两周一次的奥沙利铂联合48小时持续输注5-氟尿嘧啶/亚叶酸钙（5-FU/LV）治疗晚期BTC的疗效和毒性。
所有患者均经组织学确诊为BTC，至少有一个可测量的病灶部位，且未接受过先前的化疗。患者年龄大于20岁，东部肿瘤协作组（ECOG）体能状态评分（PS）为0-2。治疗方案为将奥沙利铂（85mg/m²）稀释于500ml 5%葡萄糖溶液（D5W）中静脉输注2小时，随后每两周一次静脉输注48小时的5-氟尿嘧啶（3000mg/m²）和亚叶酸钙（100mg/m²）。疗效评估依据实体瘤疗效评价标准（RECIST），每两个疗程进行一次；毒性评估依据美国国立癌症研究所（NCI）通用毒性标准第3.0版。
2005年8月至2006年12月，34例初治的晚期BTC患者入组，32例接受意向性治疗的患者纳入评估。部分缓解率为18.8%，疾病稳定率为31.3%，疾病控制率为50.0%。中位疾病进展时间和生存期分别为3.7个月和7个月。最常见的3/4级毒性反应为中性粒细胞减少15.6%（5/32）、口腔炎9.4%（3/32）、血小板减少6.3%（2/32）、腹泻6.3%（2/32）和神经病变3.1%（1/32）。未发生与治疗相关的死亡。
对于晚期BTC患者，每两周一次的奥沙利铂联合48小时持续输注5-FU/LV显示出可耐受的毒性，且疗效与其他联合治疗方案相当。
