BILCAP trial and adjuvant capecitabine in resectable biliary tract cancer: reflections on a standard of care
BILCAP trial and adjuvant capecitabine in resectable biliary tract cancer: reflections on a standard of care
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DOI：
10.1080/17474124.2021.1864325
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发表时间：
2020-12-20
影响因子：
3.9
通讯作者：
Brandi, Giovanni
中科院分区：
文献类型：
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作者：
Rizzo, Alessandro;Brandi, Giovanni
胆道癌（BTC）是一组异质性侵袭性恶性肿瘤，包括壶腹癌、胆囊癌、肝外胆管癌和肝内胆管癌；不幸的是，切除的 BTC 中远处和局部区域复发的发生率仍然很高，大约 60-70% 的患者会出现疾病复发。直到几年前，辅助治疗主要基于荟萃分析的结果，包括异质性回顾性研究，并显示在选定的淋巴结阳性疾病和/或 R1 切除的 BTC 患者群体中具有生存获益。最近，一些前瞻性随机临床试验的结果已经提出并发表。其中，尽管比较辅助卡培他滨与安慰剂的随机 III 期 BILCAP 试验未能通过意向治疗分析达到其主要终点，但预先计划的敏感性分析强调了生存获益，导致卡培他滨被广泛采用作为辅助治疗。然而，仍然存在一些悬而未决的问题，包括：标准卡培他滨是否可以代表这种情况下有效、真正的护理标准？在此，我们讨论 BILCAP 研究的结果，特别关注该试验对全球日常临床实践的影响。
Biliary tract cancer (BTC) is a heterogeneous group of aggressive malignancies comprising ampulla of Vater cancer, gallbladder cancer, extrahepatic cholangiocarcinoma, and intrahepatic cholangiocarcinoma; unfortunately, the incidence of distant and locoregional recurrence remains high in resected BTCs, with approximately 60-70% of the patients who will experience disease relapse. Until a few years ago, adjuvant treatment was mainly based on the results of a meta-analysis including heterogeneous retrospective studies and showing a survival benefit in the selected populations of resected BTC patients with node-positive disease and/or R1 resection. More recently, the results of several prospective randomized clinical trials have been presented and published. Among these, although the randomized phase III BILCAP trial comparing adjuvant capecitabine versus placebo failed to meet its primary endpoint by intention-to-treat analysis, the preplanned sensitivity analysis highlighted a survival benefit, leading to the wide adoption of capecitabine as adjuvant treatment. However, several unanswered questions remain, including the following: may standard capecitabine represent the effective, real standard of care in this setting? Herein, we discuss the results of the BILCAP study, with a particular focus on the impact the trial had in everyday clinical practice worldwide.