A randomized, double-blind, placebo-controlled phase II study to assess the efficacy and safety of mapatumumab with sorafenib in patients with advanced hepatocellular carcinoma

Annals of Oncology : Official Journal of the European Society for Medical Oncology
T CiuleanuW Sun

Abstract

This randomized, double-blind, placebo-controlled, phase II study evaluated the efficacy and safety of mapatumumab (a human agonistic monoclonal antibody against tumor necrosis factor-related apoptosis-inducing ligand receptor 1) in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC). Patients with advanced HCC (stratified by Barcelona Clinic Liver Cancer stage and Eastern Cooperative Oncology Group performance status) were randomized 1:1 to receive sorafenib (400 mg, twice daily per 21-day cycle) and either placebo (placebo-sorafenib arm) or mapatumumab (30 mg/kg on day 1 per 21-day cycle; mapatumumab-sorafenib arm). The primary end point was time to (radiologic) progression (TTP), assessed by blinded independent central review. Key secondary end points included progression-free survival, overall survival, and objective response. In total, 101 patients were randomized (placebo-sorafenib arm: N = 51; mapatumumab-sorafenib arm: N = 50). There was no significant difference in median TTP between both arms [5.6 versus 4.1 months, respectively; adjusted hazard ratio (one-sided 90% confidence interval) 1.192 (0-1.737)]. No mapatumumab-related benefit was identified when TTP was evaluated in the stratif...Continue Reading

References

Dec 1, 1982·American Journal of Clinical Oncology·M M OkenP P Carbone
Jul 20, 1999·The Journal of Clinical Investigation·A AshkenaziR H Schwall
Oct 13, 1999·Seminars in Liver Disease·J M LlovetJ Bruix
Feb 6, 2004·Liver Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society·Josep M LlovetUNKNOWN Barcelona-Clínic Liver Cancer Group
Apr 20, 2004·Molecular Therapy : the Journal of the American Society of Gene Therapy·Pavel SovaAndré Lieber
May 20, 2004·The Journal of Histochemistry and Cytochemistry : Official Journal of the Histochemistry Society·Diana C SpieringsSteven de Jong
Apr 10, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Anthony W TolcherRoger B Cohen
Feb 8, 2008·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·F Anthony GrecoJerry Klein
Apr 29, 2008·Advances in Experimental Medicine and Biology·Robin C Humphreys, Wendy Halpern
May 15, 2008·Journal of the National Cancer Institute·Josep M LlovetUNKNOWN Panel of Experts in HCC-Design Clinical Trials
Jun 4, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Sébastien J HotteAmit M Oza
Jul 25, 2008·The New England Journal of Medicine·Josep M LlovetUNKNOWN SHARP Investigators Study Group
Jul 31, 2008·World Journal of Gastroenterology : WJG·Asmaa-Ibrahim GomaaSimon-D Taylor-Robinson
Aug 5, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stephen LeongS Gail Eckhardt
Aug 20, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Constantijne H MomStefan Sleijfer
Oct 1, 2009·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Xiaozhen ZhangShyam Kottilil
Dec 17, 2009·World Journal of Gastroenterology : WJG·Bruno-Christian KoehlerHenning Schulze-Bergkamen
Feb 23, 2010·Seminars in Liver Disease·Riccardo Lencioni, Josep M Llovet
Feb 23, 2010·Seminars in Liver Disease·Alejandro FornerJordi Bruix
Mar 4, 2010·Molecular Cancer Therapeutics·Shengbing Huang, Frank A Sinicrope
Oct 5, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Kuen-Feng ChenAnn-Lii Cheng
Oct 5, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Lydia KrieglEnrico N De Toni
Aug 28, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Philip J JohnsonAnn-Lii Cheng
Oct 2, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ann-Lii ChengEric Raymond
Oct 22, 2013·JAMA : the Journal of the American Medical Association·UNKNOWN World Medical Association
Jul 6, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Masatoshi KudoJian-Hua Wang
Sep 16, 2014·International Journal of Cancer. Journal International Du Cancer·Jacques FerlayFreddie Bray
Dec 10, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Calin CainapSaied El-Nowiem

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Citations

May 10, 2017·Transplant International : Official Journal of the European Society for Organ Transplantation·Pietro E Cippà, Thomas Fehr
Mar 24, 2020·Nature Reviews. Clinical Oncology·Benedito A Carneiro, Wafik S El-Deiry
Oct 28, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Shuichi AokiDan G Duda
Jul 29, 2016·World Journal of Gastroenterology : WJG·Liliana MontellaSalvatore Del Prete
Mar 16, 2018·Cancer Metastasis Reviews·Xun YuanGen Sheng Wu
Jun 11, 2020·Therapeutic Advances in Medical Oncology·Guanghan FanXiao Xu
Oct 25, 2017·Antibodies·Agathe Dubuisson, Olivier Micheau
Sep 29, 2019·Critical Reviews in Oncology/hematology·Sonia How Ming WongSiew Ching Ngai
Apr 4, 2021·Cancers·Olivia A Diaz Arguello, Hidde J Haisma
Jul 9, 2021·Apoptosis : an International Journal on Programmed Cell Death·Xiaofeng DaiJianying Zhang

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