Osman Öcal1, Kerstin Schütte2,3, Christoph J Zech4, Christian Loewe5, Otto van Delden6, Vincent Vandecaveye7, Chris Verslype8, Bernhard Gebauer9, Christian Sengel10, Irene Bargellini11, Roberto Iezzi12, Alexander Philipp13, Thomas Berg14, Heinz J Klümpen15, Julia Benckert16, Maciej Pech17, Antonio Gasbarrini18, Holger Amthauer19, Peter Bartenstein20, Bruno Sangro21, Peter Malfertheiner13, Jens Ricke1, Max Seidensticker22. 1. Department of Radiology, University Hospital, LMU Munich, Marchioninistrasse 15, 81377, Munich, Germany. 2. Department of Internal Medicine and Gastroenterology, Niels-Stensen-Kliniken Marienhospital, Osnabrück, Germany. 3. Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover (MHH), Carl-Neuberg-Straße 1, 30625, Hannover, Deutschland. 4. Radiology and Nuclear Medicine, University Hospital Basel, University of Basel, Basel, Switzerland. 5. Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria. 6. Department of Radiology and Nuclear Medicine, Academic University Medical Centers, Amsterdam, The Netherlands. 7. Department of Radiology, University Hospitals Leuven, Leuven, Belgium. 8. Department of Digestive Oncology, University Hospitals Leuven, Leuven, Belgium. 9. Department of Radiology, Charité - University Medicine Berlin, Berlin, Germany. 10. Radiology Department, Grenoble University Hospital, La Tronche, France. 11. Department of Vascular and Interventional Radiology, University Hospital of Pisa, Pisa, Italy. 12. UOC di Radiologia, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 13. Department of Medicine II, University Hospital, LMU Munich, Munich, Germany. 14. Klinik und Poliklinik für Gastroenterologie, Sektion Hepatologie, Universitätsklinikum Leipzig, Leipzig, Germany. 15. Department of Medical Oncology, Amsterdam University Medical Centers, Amsterdam, the Netherlands. 16. Department of Hepatology and Gastroenterology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany. 17. Departments of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany. 18. Fondazione Policlinico Universitario Gemelli IRCCS, Universita' Cattolica del Sacro Cuore, Rome, Italy. 19. Corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin, Department of Nuclear Medicine, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. 20. Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany. 21. Liver Unit, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain. 22. Department of Radiology, University Hospital, LMU Munich, Marchioninistrasse 15, 81377, Munich, Germany. max.seidensticker@med.uni-muenchen.de.
Abstract
PURPOSE: To compare the treatment response and progression-free survival (PFS) in advanced hepatocellular carcinoma (HCC) patients who received sorafenib treatment either alone or combined with radioembolization (RE). METHODS: Follow-up images of the patients treated within a multicenter phase II trial (SORAMIC) were assessed by mRECIST. A total of 177 patients (73 combination arm [RE + sorafenib] and 104 sorafenib arm) were included in this post-hoc analysis. Response and progression characteristics were compared between treatment arms. Survival analyses were done to compare PFS and post-progression survival between treatment arms. Multivariate Cox regression analysis was used to compare survival with factors known to influence PFS in patients with HCC. RESULTS: The combination arm had significantly higher objective response rate (61.6% vs. 29.8%, p < 0.001), complete response rate (13.7% vs. 3.8%, p = 0.022), and a trend for higher disease control rate (79.2% vs. 72.1%, p = 0.075). Progression was encountered in 116 (65.5%) patients and was more common in the sorafenib arm (75% vs. 52.0%, p = 0.001). PFS (median 8.9 vs. 5.4 months, p = 0.022) and hepatic PFS were significantly better in the combination arm (9.0 vs. 5.7 months, p = 0.014). Multivariate analysis confirmed the treatment arm as an independent predictor of PFS. CONCLUSION: In advanced HCC patients receiving sorafenib, combination with RE has an additive anticancer effect on sorafenib treatment resulting in a higher and longer tumor response. However, the enhanced response did not translate into prolonged survival. Better patient selection and superselective treatment could improve outcomes after combination therapy.
PURPOSE: To compare the treatment response and progression-free survival (PFS) in advanced hepatocellular carcinoma (HCC) patients who received sorafenib treatment either alone or combined with radioembolization (RE). METHODS: Follow-up images of the patients treated within a multicenter phase II trial (SORAMIC) were assessed by mRECIST. A total of 177 patients (73 combination arm [RE + sorafenib] and 104 sorafenib arm) were included in this post-hoc analysis. Response and progression characteristics were compared between treatment arms. Survival analyses were done to compare PFS and post-progression survival between treatment arms. Multivariate Cox regression analysis was used to compare survival with factors known to influence PFS in patients with HCC. RESULTS: The combination arm had significantly higher objective response rate (61.6% vs. 29.8%, p < 0.001), complete response rate (13.7% vs. 3.8%, p = 0.022), and a trend for higher disease control rate (79.2% vs. 72.1%, p = 0.075). Progression was encountered in 116 (65.5%) patients and was more common in the sorafenib arm (75% vs. 52.0%, p = 0.001). PFS (median 8.9 vs. 5.4 months, p = 0.022) and hepatic PFS were significantly better in the combination arm (9.0 vs. 5.7 months, p = 0.014). Multivariate analysis confirmed the treatment arm as an independent predictor of PFS. CONCLUSION: In advanced HCC patients receiving sorafenib, combination with RE has an additive anticancer effect on sorafenib treatment resulting in a higher and longer tumor response. However, the enhanced response did not translate into prolonged survival. Better patient selection and superselective treatment could improve outcomes after combination therapy.
Authors: Philip Hilgard; Monia Hamami; Amr El Fouly; André Scherag; Stefan Müller; Judith Ertle; Till Heusner; Vito R Cicinnati; Andreas Paul; Andreas Bockisch; Guido Gerken; Gerald Antoch Journal: Hepatology Date: 2010-11 Impact factor: 17.425
Authors: Bruno Sangro; Livio Carpanese; Roberto Cianni; Rita Golfieri; Daniele Gasparini; Samer Ezziddin; Philipp M Paprottka; Francesco Fiore; Mark Van Buskirk; Jose Ignacio Bilbao; Giuseppe Maria Ettorre; Rita Salvatori; Emanuela Giampalma; Onelio Geatti; Kai Wilhelm; Ralf Thorsten Hoffmann; Francesco Izzo; Mercedes Iñarrairaegui; Carlo Ludovico Maini; Carlo Urigo; Alberta Cappelli; Alessandro Vit; Hojjat Ahmadzadehfar; Tobias Franz Jakobs; Secondo Lastoria Journal: Hepatology Date: 2011-06-30 Impact factor: 17.425
Authors: Richard S Finn; Shukui Qin; Masafumi Ikeda; Peter R Galle; Michel Ducreux; Tae-You Kim; Masatoshi Kudo; Valeriy Breder; Philippe Merle; Ahmed O Kaseb; Daneng Li; Wendy Verret; Derek-Zhen Xu; Sairy Hernandez; Juan Liu; Chen Huang; Sohail Mulla; Yulei Wang; Ho Yeong Lim; Andrew X Zhu; Ann-Lii Cheng Journal: N Engl J Med Date: 2020-05-14 Impact factor: 91.245
Authors: Riad Salem; Robert J Lewandowski; Mary F Mulcahy; Ahsun Riaz; Robert K Ryu; Saad Ibrahim; Bassel Atassi; Talia Baker; Vanessa Gates; Frank H Miller; Kent T Sato; Ed Wang; Ramona Gupta; Al B Benson; Steven B Newman; Reed A Omary; Michael Abecassis; Laura Kulik Journal: Gastroenterology Date: 2009-09-18 Impact factor: 22.682
Authors: Josep M Llovet; Sergio Ricci; Vincenzo Mazzaferro; Philip Hilgard; Edward Gane; Jean-Frédéric Blanc; Andre Cosme de Oliveira; Armando Santoro; Jean-Luc Raoul; Alejandro Forner; Myron Schwartz; Camillo Porta; Stefan Zeuzem; Luigi Bolondi; Tim F Greten; Peter R Galle; Jean-François Seitz; Ivan Borbath; Dieter Häussinger; Tom Giannaris; Minghua Shan; Marius Moscovici; Dimitris Voliotis; Jordi Bruix Journal: N Engl J Med Date: 2008-07-24 Impact factor: 91.245
Authors: Enrico N De Toni; Anne Schlesinger-Raab; Martin Fuchs; Wolfgang Schepp; Ursula Ehmer; Fabian Geisler; Jens Ricke; Philipp Paprottka; Helmut Friess; Jens Werner; Alexander L Gerbes; Julia Mayerle; Jutta Engel Journal: Gut Date: 2019-03-16 Impact factor: 23.059