J Bridgewater1, A Lopes2, H Wasan3, D Malka4, L Jensen5, T Okusaka6, J Knox7, D Wagner8, D Cunningham9, J Shannon10, D Goldstein11, M Moehler12, T Bekaii-Saab13, M G McNamara14, J W Valle14. 1. UCL Cancer Institute, UCL, London j.bridgewater@ucl.ac.uk. 2. UCL and CRUK Clinical Trials Centre, UCL, London. 3. Department of Oncology, Imperial Healthcare, London, UK. 4. Department of Cancer Medicine, Institute Gustave Roussy, Paris, France. 5. Department of Oncology, Vejle Hospital, Vejle, Denmark. 6. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Centre Hospital, Tokyo, Japan. 7. Department of Oncology, Princess Margaret Cancer Centre, Toronto, Canada. 8. Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. 9. Department of Medicine, Royal Marsden Hospital, Sutton, UK. 10. Department of Oncology, Nepean Cancer Centre, Sydney. 11. Department of Oncology, Prince of Wales Hospital, Sydney, Australia. 12. Department of Internal Medicine, Johannes Gutenberg-University of Mainz, Mainz, Germany. 13. Department of Oncology, The Ohio State University, Columbus, USA. 14. Institute of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
Abstract
BACKGROUND: Biliary tract cancer is an uncommon cancer with a poor outcome. We assembled data from the National Cancer Research Institute (UK) ABC-02 study and 10 international studies to determine prognostic outcome characteristics for patients with advanced disease. METHODS: Multivariable analyses of the final dataset from the ABC-02 study were carried out. All variables were simultaneously included in a Cox proportional hazards model, and backward elimination was used to produce the final model (using a significance level of 10%), in which the selected variables were associated independently with outcome. This score was validated externally by receiver operating curve (ROC) analysis using the independent international dataset. RESULTS: A total of 410 patients were included from the ABC-02 study and 753 from the international dataset. An overall survival (OS) and progression-free survival (PFS) Cox model was derived from the ABC-02 study. White blood cells, haemoglobin, disease status, bilirubin, neutrophils, gender, and performance status were considered prognostic for survival (all with P < 0.10). Patients with metastatic disease {hazard ratio (HR) 1.56 [95% confidence interval (CI) 1.20-2.02]} and Eastern Cooperative Oncology Group performance status (ECOG PS) 2 had worse survival [HR 2.24 (95% CI 1.53-3.28)]. In a dataset restricted to patients who received cisplatin and gemcitabine with ECOG PS 0 and 1, only haemoglobin, disease status, bilirubin, and neutrophils were associated with PFS and OS. ROC analysis suggested the models generated from the ABC-02 study had a limited prognostic value [6-month PFS: area under the curve (AUC) 62% (95% CI 57-68); 1-year OS: AUC 64% (95% CI 58-69)]. CONCLUSION: These data propose a set of prognostic criteria for outcome in advanced biliary tract cancer derived from the ABC-02 study that are validated in an international dataset. Although these findings establish the benchmark for the prognostic evaluation of patients with ABC and confirm the value of longheld clinical observations, the ability of the model to correctly predict prognosis is limited and needs to be improved through identification of additional clinical and molecular markers.
BACKGROUND:Biliary tract cancer is an uncommon cancer with a poor outcome. We assembled data from the National Cancer Research Institute (UK) ABC-02 study and 10 international studies to determine prognostic outcome characteristics for patients with advanced disease. METHODS: Multivariable analyses of the final dataset from the ABC-02 study were carried out. All variables were simultaneously included in a Cox proportional hazards model, and backward elimination was used to produce the final model (using a significance level of 10%), in which the selected variables were associated independently with outcome. This score was validated externally by receiver operating curve (ROC) analysis using the independent international dataset. RESULTS: A total of 410 patients were included from the ABC-02 study and 753 from the international dataset. An overall survival (OS) and progression-free survival (PFS) Cox model was derived from the ABC-02 study. White blood cells, haemoglobin, disease status, bilirubin, neutrophils, gender, and performance status were considered prognostic for survival (all with P < 0.10). Patients with metastatic disease {hazard ratio (HR) 1.56 [95% confidence interval (CI) 1.20-2.02]} and Eastern Cooperative Oncology Group performance status (ECOG PS) 2 had worse survival [HR 2.24 (95% CI 1.53-3.28)]. In a dataset restricted to patients who received cisplatin and gemcitabine with ECOG PS 0 and 1, only haemoglobin, disease status, bilirubin, and neutrophils were associated with PFS and OS. ROC analysis suggested the models generated from the ABC-02 study had a limited prognostic value [6-month PFS: area under the curve (AUC) 62% (95% CI 57-68); 1-year OS: AUC 64% (95% CI 58-69)]. CONCLUSION: These data propose a set of prognostic criteria for outcome in advanced biliary tract cancer derived from the ABC-02 study that are validated in an international dataset. Although these findings establish the benchmark for the prognostic evaluation of patients with ABC and confirm the value of longheld clinical observations, the ability of the model to correctly predict prognosis is limited and needs to be improved through identification of additional clinical and molecular markers.
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Authors: Pavan Najran; Angela Lamarca; Damian Mullan; Mairéad G McNamara; Thomas Westwood; Richard A Hubner; Jeremy Lawrence; Prakash Manoharan; Jon Bell; Juan W Valle Journal: Curr Oncol Rep Date: 2017-07 Impact factor: 5.075
Authors: Julia S Johansen; Jesper B Andersen; Dan Høgdall; Colm J O'Rourke; Christian Dehlendorff; Ole F Larsen; Lars H Jensen; Astrid Z Johansen; Hien Dang; Valentina M Factor; Mie Grunnet; Morten Mau-Sørensen; Douglas V N P Oliveira; Dorte Linnemann; Mogens K Boisen; Xin W Wang Journal: Clin Cancer Res Date: 2020-09-15 Impact factor: 13.801