Dilara Akhoundova Sanoyan1, Mairéad G McNamara2,3, Angela Lamarca3, Juan W Valle2,3. 1. Department of Medical Oncology and Hematology, University Hospital Zurich, Zurich, Switzerland. 2. Division of Cancer Sciences, University of Manchester. 3. Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Abstract
PURPOSE OF REVIEW: Biliary tract cancers (BTCs) have a poor prognosis; most patients present with advanced disease and, even after surgical resection for early-stage disease local and distant relapses are frequent. Involved resection margins and lymph node involvement are the most relevant known adverse prognostic factors. Historically clinicians have made clinical decisions based on data from institutional series and uncontrolled studies, with their inherent limitations. In this review, data from recently-reported prospective randomized trials are reviewed and clinical implications discussed. RECENT FINDINGS: Results from prospective randomized phase III trials (namely BILCAP, PRODIGE-12, and BCAT) are reviewed: none of the studies met their primary endpoint by intention-to-treat analysis. However, following a per-protocol sensitivity analysis of the BILCAP study, adjuvant capecitabine (for 6 months) showed a clinically-relevant improvement in overall survival and provides reference data for future clinical trials. SUMMARY: Adjuvant chemotherapy with capecitabine should be considered following curative resection of BTC. Identification of benefit in anatomical subgroups is ongoing and future trials should also consider the implication of molecular subtypes of BTC (for prognostic impact and on-target therapeutic options).
PURPOSE OF REVIEW: Biliary tract cancers (BTCs) have a poor prognosis; most patients present with advanced disease and, even after surgical resection for early-stage disease local and distant relapses are frequent. Involved resection margins and lymph node involvement are the most relevant known adverse prognostic factors. Historically clinicians have made clinical decisions based on data from institutional series and uncontrolled studies, with their inherent limitations. In this review, data from recently-reported prospective randomized trials are reviewed and clinical implications discussed. RECENT FINDINGS: Results from prospective randomized phase III trials (namely BILCAP, PRODIGE-12, and BCAT) are reviewed: none of the studies met their primary endpoint by intention-to-treat analysis. However, following a per-protocol sensitivity analysis of the BILCAP study, adjuvant capecitabine (for 6 months) showed a clinically-relevant improvement in overall survival and provides reference data for future clinical trials. SUMMARY: Adjuvant chemotherapy with capecitabine should be considered following curative resection of BTC. Identification of benefit in anatomical subgroups is ongoing and future trials should also consider the implication of molecular subtypes of BTC (for prognostic impact and on-target therapeutic options).
Authors: Stephen P Hack; Wendy Verret; Sohail Mulla; Bo Liu; Yulei Wang; Teresa Macarulla; Zhenggang Ren; Anthony B El-Khoueiry; Andrew X Zhu Journal: Ther Adv Med Oncol Date: 2021-07-31 Impact factor: 8.168
Authors: Alessandro Rizzo; Riccardo Carloni; Giorgio Frega; Andrea Palloni; Alessandro Di Federico; Angela Dalia Ricci; Raffaele De Luca; Simona Tavolari; Giovanni Brandi Journal: Curr Oncol Date: 2022-07-19 Impact factor: 3.109