Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy.
Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy.
Cancer Treat Res Commun. 2021;27:100334. doi: 10.1016/j.ctarc.2021.100334. Epub 2021 Feb 12.
Biliary tract cancer (BTC) includes a heterogeneous group of aggressive malignancies comprising gallbladder cancer (GBC), ampulla of Vater cancer (AVC), intrahepatic cholangiocarcinoma (iCCA), and extrahepatic cholangiocarcinoma (eCCA). Unfortunately, potentially curative resection is possible in approximately the 25% of presenting patients, and relapse rates are high, with a notable proportion of BTCs experiencing disease recurrence. Recent years have seen the publication of several prospective clinical trials evaluating the role of adjuvant systemic treatments, and among these, the phase III BILCAP study provided evidence supporting the use of capecitabine after radical surgery in BTC patients; in fact, although the study failed to meet its primary endpoint, the capecitabine arm showed improved clinical outcomes in terms of overall survival (pre-planned sensitivity analysis in the intention-to-treat population and in the per-protocol analysis) and relapse-free survival. However, the BILCAP has been widely criticized, with several authors that have not accepted adjuvant capecitabine as novel standard of care. In this review, we summarize current state of the art regarding adjuvant systemic treatment in BTC, highlighting advantages and disadvantages of recent clinical trials, and suggesting new research directions in this setting.
胆道癌（BTC）包括一组异质性的侵袭性恶性肿瘤，包括胆囊癌（GBC）、壶腹癌（AVC）、肝内胆管癌（iCCA）和肝外胆管癌（eCCA）。不幸的是，约 25%的患者可通过潜在治愈性手术切除，且复发率较高，相当一部分 BTC 患者会出现疾病复发。近年来，已发表了多项评估辅助系统治疗作用的前瞻性临床试验，其中 III 期 BILCAP 研究为 BTC 患者根治术后使用卡培他滨提供了证据；事实上，尽管该研究未能达到主要终点，但卡培他滨组在总生存期（意向治疗人群和方案分析中的预先计划的敏感性分析）和无复发生存期方面显示出改善的临床结局。然而，BILCAP 受到了广泛的批评，一些作者不接受辅助卡培他滨作为新的标准治疗。在这篇综述中，我们总结了 BTC 辅助系统治疗的最新进展，强调了最近临床试验的优缺点，并提出了该领域的新研究方向。
