Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Oncology. 2012;83(2):57-66. doi: 10.1159/000338795. Epub 2012 Jun 29.
The purpose of this study was to determine the efficacy and safety of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) as salvage chemotherapy in biliary tract cancer (BTC) and to identify prognostic factors.
Fifty patients received 5-FU 800 mg/m(2) over 10 h on days 1-5, doxorubicin 30 mg/m(2) on day 1 and mitomycin-C 8 mg/m(2) on day 1, every 4 weeks. The primary endpoint was the overall survival (OS) rate at 6 months.
The responses to iFAM were as follows: partial response in 2 patients (4.2%) and stable disease in 9 patients (18.7%). The median progression-free survival and OS were 2.2 months and 5.6 months, respectively. The 6-month OS rate was 48%. Grade 3/4 adverse events included neutropenia (10%), thrombocytopenia (8%), and anemia (2%). Based on multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status, serum albumin, and response to previous chemotherapy were significantly associated with OS. Three risk groups based on the number of 3 poor prognostic factors (0 vs. 1 vs. 2-3) were well correlated to OS (8.7 vs. 5.5 vs. 2.4 months, respectively; p = 0.0002).
iFAM as salvage regimen has modest effect and tolerable toxicity in advanced BTC. The described risk group classification may help guide treatment plans.
本研究旨在确定氟尿嘧啶（5-FU）、多柔比星和丝裂霉素-C（iFAM）输注作为胆道癌（BTC）挽救性化疗的疗效和安全性，并确定预后因素。
50 例患者接受 5-FU 800mg/m²，静脉滴注 10 小时，第 1-5 天；多柔比星 30mg/m²，第 1 天；丝裂霉素-C 8mg/m²，第 1 天，每 4 周一次。主要终点是 6 个月时的总生存率（OS）率。
iFAM 的反应如下：2 例（4.2%）部分缓解，9 例（18.7%）稳定疾病。中位无进展生存期和 OS 分别为 2.2 个月和 5.6 个月。6 个月 OS 率为 48%。3/4 级不良事件包括中性粒细胞减少（10%）、血小板减少（8%）和贫血（2%）。基于多变量分析，东部合作肿瘤学组（ECOG）表现状态、血清白蛋白和对先前化疗的反应与 OS 显著相关。根据 3 个不良预后因素的数量（0 与 1 与 2-3）将患者分为 3 个风险组，与 OS 密切相关（8.7 与 5.5 与 2.4 个月，分别；p=0.0002）。
iFAM 作为挽救方案在晚期 BTC 中具有中等疗效和可耐受的毒性。描述的风险组分类可能有助于指导治疗计划。
