Efficacy and Safety of S-1 Monotherapy in Patients with Advanced Biliary Tract Adenocarcinoma Retrospective Analysis of 162 Patients
Efficacy and Safety of S-1 Monotherapy in Patients with Advanced Biliary Tract Adenocarcinoma Retrospective Analysis of 162 Patients
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DOI：
10.1159/000195538
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发表时间：
2009-01-01
期刊：
影响因子：
3.5
通讯作者：
Lee, Jungshin
中科院分区：
文献类型：
--
作者：
Park, Inkeun;Lee, Jae-Lyun;Lee, Jungshin
目的：在临床实践中研究S-1单药治疗晚期胆道腺癌（BTA）的疗效和安全性。方法：我们回顾了2004年8月至2007年9月期间接受S- 1单药治疗的217例晚期BTA患者的临床资料。结果：鉴定出162例符合条件的患者。原发肿瘤为肝内（n = 57）、胆囊（n = 50）、肝外胆管（n = 41）和壶腹（n = 14）。120例可评估患者中有16例达到部分缓解，缓解率为13.3% （95% CI 7.2-19.4%）。另有51例患者病情稳定，总体肿瘤控制率为55.8% （95% CI 46.9-64.7%）。中位进展时间为2.7个月，中位总生存时间为6.9个月。不同肿瘤原发部位的有效率和生存率差异有统计学意义（p = 0.002和p < 0.001），肝外胆管腺癌预后最好。该治疗方案在大多数情况下仅产生轻度毒性（1级或2级），即使对高胆红素血症患者也是如此。结论：S-1具有良好的毒性，可安全用于BTA合并高胆红素血症患者。S-1治疗晚期BTA的疗效取决于肿瘤部位，对肝外BTA患者最有效。版权所有(C) 2009 S. Karger AG，巴塞尔
Aim: We investigated the efficacy and safety of S-1 monotherapy for the treatment of advanced biliary tract adenocarcinoma (BTA) in a clinical practice setting. Methods: We reviewed clinical data from 217 patients with advanced BTA who were treated with S- 1 monotherapy between August 2004 and September 2007. Results: 162 eligible patients were identified. The primary tumors were intrahepatic (n = 57), in the gall bladder ( n = 50), in extrahepatic bile ducts ( n = 41) and in the ampulla of Vater ( n = 14). Sixteen of 120 assessable patients achieved partial responses, with a response rate of 13.3% (95% CI 7.2-19.4%). Another 51 patients had stable disease, with an overall tumor control rate of 55.8% ( 95% CI 46.9-64.7%). The median time to progression was 2.7 months and the median overall survival time was 6.9 months. Response rates and survival differed significantly according to the primary site of the tumor ( p = 0.002 and p < 0.001, respectively), with extrahepatic bile duct adenocarcinoma having the best prognosis. The treatment regimen produced only mild toxicity in most cases ( grade 1 or 2), even for patients with hyperbilirubinemia. Conclusion: S-1 has a favorable toxicity profile and can be safely administered to BTA patients with hyperbilirubinemia. The efficacy of S-1 against advanced BTA depends on the tumor site and is most effective in patients with extrahepatic BTA. Copyright (C) 2009 S. Karger AG, Basel