Cindy Neuzillet1, Andrea Casadei Gardini2, Bertrand Brieau3, Caterina Vivaldi4, Cristina Smolenschi5, Giovanni Brandi6, David Tougeron7, Roberto Filippi8, Angélique Vienot9, Nicola Silvestris10, Anne-Laure Pointet11, Sara Lonardi12, Benoît Rousseau13, Mario Scartozzi14, Laetitia Dahan15, Giuseppe Aprile16, Tarek Boussaha17, David Malka5, Shantini M Crusz18, Samuel Le Sourd19, Aurélia Meurisse20, Astrid Lièvre21, Dewi Vernerey22. 1. Medical Oncology, Curie Institute, Versailles Saint-Quentin University, Saint-Cloud, France; Medical Oncology, Henri Mondor University Hospital, AP-HP, Créteil, France. Electronic address: cindy.neuzillet@curie.fr. 2. Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Italy. 3. Gastroenterology, Cochin University Hospital, AP-HP, Paris, France. 4. Oncology, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 5. GI Oncology, Gustave Roussy Institute, Villejuif, France. 6. Oncology, Policlinico S. Orsola-Malpighi, Bologna, Italy. 7. Hepato-Gastroenterology, Poitiers University Hospital, Jean Bernard Hôpital, Poitiers, France. 8. Medical Oncology, Candiolo Cancer Institute, FPO, IRCCS, Candiolo, Italy; Department of Oncology, University of Turin, Italy. 9. Oncology, Besançon University Hospital, Besançon, France. 10. Medical Oncology Unit and Scientific Directorate, Cancer Institute "Giovanni Paolo II", Bari, Italy. 11. Gastroenterology and GI Oncology, George Pompidou European University Hospital, AP-HP, Paris, France. 12. Medical Oncology 1 Unit, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy. 13. Medical Oncology, Henri Mondor University Hospital, AP-HP, Créteil, France. 14. Medical Oncology Unit, University of Cagliari, Cagliari, Italy. 15. Pôle "DACCORD" (Digestif, Anatomie Pathologique, Chirurgie, CISIH, Oncologie, Radiothérapie, Dermatologie), Service d'Oncologie Digestive, CHU Timone, Marseille, France. 16. Department of Oncology, Ospedale San Bortolo, Azienda ULSS8 Berica, Distretto Est, Vicenza, Italy; Department of Oncology, University Hospital of Udine, Udine, Italy. 17. Oncology, Centre Multidisciplinaire d'Oncologie-CePo, Lausanne, Switzerland. 18. Oncology, Barts Cancer Institute-Queen Mary University of London, London, United Kingdom. 19. Gastroenterology and Hepatology, Centre Eugène Marquis, Rennes, France. 20. Methodology and Quality of Life in Oncology Unit, Besançon University Hospital, Besançon, France; Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France. 21. Gastroenterology, Pontchaillou University Hospital, Rennes, France; Rennes 1 University, Rennes, France. 22. Methodology and Quality of Life in Oncology Unit, Besançon University Hospital, Besançon, France; Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France. Electronic address: dvernerey@chu-besancon.fr.
Abstract
BACKGROUND: The benefit of second-line chemotherapy (L2) over standard first-line (L1) gemcitabine plus cisplatin (GEMCIS) or oxaliplatin (GEMOX) chemotherapy in advanced biliary tract cancer (aBTC) is unclear. Our aim was to identify and validate prognostic factors for overall survival (OS) with L2 in aBTC to guide clinical decisions in this setting. METHODS: We performed a retrospective analysis of four prospective patient cohorts: a development cohort (28 French centres) and three validation cohorts from Italy, UK and France. All consecutive patients with aBTC receiving L2 after GEMCIS/GEMOX L1 between 2003 and 2016 were included. The association of clinicobiological data with OS was investigated in univariate and multivariate Cox analyses. A simple score was derived from the multivariate model. RESULTS: The development cohort included 405 patients treated with L1 GEMOX (91%) or GEMCIS. Of them, 55.3% were men, and median age was 64.8 years. Prior surgical resection was observed in 26.7%, and 94.8% had metastatic disease. Performance status (PS) was 0, 1 and 2 in 17.8%, 52.4% and 29.7%, respectively. Among 22 clinical parameters, eight were associated with OS in univariate analysis. In multivariate analysis, four were independent prognostic factors (p < 0.05): PS, reason for L1 discontinuation, prior resection of primary tumour and peritoneal carcinomatosis. The model had the Harrell's concordance index of 0.655, a good calibration and was validated in the three external cohorts (N = 392). CONCLUSION: We validated previously reported predictive factors of OS with L2 and identified peritoneal carcinomatosis as a new pejorative factor in nearly 800 patients. Our model and score may be useful in daily practice and for future clinical trial design.
BACKGROUND: The benefit of second-line chemotherapy (L2) over standard first-line (L1) gemcitabine plus cisplatin (GEMCIS) or oxaliplatin (GEMOX) chemotherapy in advanced biliary tract cancer (aBTC) is unclear. Our aim was to identify and validate prognostic factors for overall survival (OS) with L2 in aBTC to guide clinical decisions in this setting. METHODS: We performed a retrospective analysis of four prospective patient cohorts: a development cohort (28 French centres) and three validation cohorts from Italy, UK and France. All consecutive patients with aBTC receiving L2 after GEMCIS/GEMOX L1 between 2003 and 2016 were included. The association of clinicobiological data with OS was investigated in univariate and multivariate Cox analyses. A simple score was derived from the multivariate model. RESULTS: The development cohort included 405 patients treated with L1 GEMOX (91%) or GEMCIS. Of them, 55.3% were men, and median age was 64.8 years. Prior surgical resection was observed in 26.7%, and 94.8% had metastatic disease. Performance status (PS) was 0, 1 and 2 in 17.8%, 52.4% and 29.7%, respectively. Among 22 clinical parameters, eight were associated with OS in univariate analysis. In multivariate analysis, four were independent prognostic factors (p < 0.05): PS, reason for L1 discontinuation, prior resection of primary tumour and peritoneal carcinomatosis. The model had the Harrell's concordance index of 0.655, a good calibration and was validated in the three external cohorts (N = 392). CONCLUSION: We validated previously reported predictive factors of OS with L2 and identified peritoneal carcinomatosis as a new pejorative factor in nearly 800 patients. Our model and score may be useful in daily practice and for future clinical trial design.
Authors: Richard D Kim; Shannon McDonough; Anthony B El-Khoueiry; Tanios S Bekaii-Saab; Stacey M Stein; Vaibhav Sahai; George P Keogh; Edward J Kim; Ari D Baron; Abby B Siegel; Afsaneh Barzi; Katherine A Guthrie; Milind Javle; Howard Hochster Journal: Eur J Cancer Date: 2020-03-29 Impact factor: 9.162
Authors: Massimiliano Salati; Luigi Marcheselli; Carlo Messina; Valeria Merz; Marco Messina; Pietro Carotenuto; Francesco Caputo; Fabio Gelsomino; Andrea Spallanzani; Luca Reggiani Bonetti; Stefania Caramaschi; Gabriele Luppi; Massimo Dominici; Michele Ghidini Journal: Cancer Manag Res Date: 2022-03-05 Impact factor: 3.989
Authors: Michael Köhler; Fabian Harders; Fabian Lohöfer; Philipp M Paprottka; Benedikt M Schaarschmidt; Jens Theysohn; Ken Herrmann; Walter Heindel; Hartmut H Schmidt; Andreas Pascher; Lars Stegger; Kambiz Rahbar; Moritz Wildgruber Journal: J Clin Med Date: 2019-12-25 Impact factor: 4.241