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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

5907 - Assessment of disease burden in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (HCC)


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Clinical Research

Tumour Site

Hepatobiliary Cancers


Jean Frédéric Blanc


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


J.F. Blanc1, T. Meyer2, A. Cheng3, A.B. El-Khoueiry4, I. Cicin5, Y. Chen6, L. Bolondi7, V. Dadduzio8, A. Baron9, Z. Lin3, J. Adriani10, R.K. Kelly11, G.K. Abou-Alfa12

Author affiliations

  • 1 Service D’hépato-gastroentérologie Et D’oncologie Digestive, Hôpital Haut-Lévêque, 33600 - CHU Bordeaux/FR
  • 2 Oncology, Royal Free Hospital, London/GB
  • 3 Oncology, National Taiwan University Hospital, Taipei/TW
  • 4 Medical Oncology, USC Norris Comprehensive Cancer Center, Los Angeles/US
  • 5 Department Of Medical Oncology, Trakya University Faculty of Medicine, Edirne/TR
  • 6 Liou Ying Chimei Hospital, Department of Medical Oncology, Tainan/TW
  • 7 University Of Bologna, Department of Medical and Surgical Sciences, Bologna/IT
  • 8 Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 9 Oncology, California Pacific Medical Center, San Francisco/US
  • 10 Clinical research & Development, Exelixis, Inc, San Francisco/US
  • 11 Medical Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 12 Oncology, Memorial Sloan Kettering Cancer Center, New York/US

Abstract 5907


Extrahepatic spread (EHS) and macrovascular invasion (MVI) are poor prognostic factors in HCC. In the CELESTIAL trial (NCT01908426), C improved overall survival (OS) and progression-free survival (PFS) vs P in patients (pts) with previously treated advanced HCC. Median OS was 10.2 mo with C vs 8.0 mo with P (HR, 0.76; 95% CI, 0.63–0.92; P = 0.0049). Median PFS was 5.2 mo with C versus 1.9 mo with P (HR, 0.44; 95% CI, 0.36–0.52; P < 0.0001). Here, we analyze OS and PFS based on (i) EHS, (ii) MVI, and (iii) the sum of target lesion diameters (SOD) at baseline.


A total of 707 pts, stratified by disease etiology, geographic region, and the presence of EHS and/or MVI, were randomized 2:1 to receive C, 60 mg once daily (N = 470) or P (N = 237). Eligible patients had a pathologic diagnosis of HCC, Child-Pugh score A, and ECOG performance status ≤1. Pts received prior sorafenib and ≤2 lines of prior systemic therapy. Tumors were assessed every 8 weeks by investigator.


In the overall population, 78% pts had EHS, 30% had MVI and 85% had EHS and/or MVI. Among pts with EHS, 50% had metastasis to the lung, 40% to lymph nodes and 17% to bones. C improved OS (HR ≤ 0.8) vs P in pts with or without MVI (Table). C also improved OS vs P in pts with EHS or high SOD. PFS was improved with C irrespective of the extent of the disease.Table: 703P

No. ptsMedian OS, moOS HR (95% CI)Median PFS, moPFS HR (95% CI)
Yes3691829.66.90.72 (0.58-0.89) (0.37-0.56)
No1015512.012.30.96 (0.63-1.46) (0.31-0.66)
Yes129817.65.30.75 (0.54-1.03) (0.31-0.58)
No33915612.49.70.80 (0.64-1.01) (0.38-0.59)
< median23112012.510.50.94 (0.71-1.24) (0.37-0.61)
≥ median2341178.25.30.58 (0.45-0.76) (0.34-0.57)


C generally improved OS in pt subgroups defined by extent of disease burden. The presence of MVI, EHS, or high SOD at baseline was associated with shorter OS in both treatment groups.

Clinical trial identification


Legal entity responsible for the study



Exelixis, Inc.

Editorial Acknowledgement


J.F. Blanc: Consulting or advisory role: Bayer, SP, BMS, Ipsen. T. Meyer: Consulting or advisory role: Bayer, BTG, Ipsen; Research funding: Bayer, BTG. A-L. Cheng: Consulting or Advisory role: Bayer Schering Pharma, Bristol-Myers Squibb, Eisai, Merck. Serono, Novartis, Ono Pharmaceutical, Onxeo; Speakers\' bureau: Novartis; Research funding: Sanofi. A.B. El-Khoueiry: Honoraria: BMS, Bayer, Exelixis, EMD Serono, EISAI, Roche, Cytomx, Merck. Consulting or advisory role: BMS, Bayer; Research funding: AstraZeneca, Astex. L. Bolondi: Consulting or advisory role: Bayer, BMS, Sirtex, Guerbet; Speakers bureau: Bayer, BMS, Sirtex, Bracco, Eli-Lilly, Guerbet, Meda-Pharm; Travel accommodations expenses: Bayer, BMS, Bracco, Sirtex, Guerbet, Eli-Lilly. V. Dadduzio: Travel, accommodations, expenses: Bayer, Amgen, Astellas. A. Baron: Speakers\' bureau: BMS, Merck, Genentech, Lilly. J. Adriani: Employee, Stock ownership: Exelixis. R.K. Kelly: Consulting or advisory role: Genentech for IDMC (self); Bayer, BMS, AstraZeneca, DebioPharm, Agios; Research funding: Adaptimmune, Agios, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Exelixis, Eli Lilly, Medimmune, Merck, Novartis, Regeneron, Sanofi, Taiho, Target Pharma Solutions, Tekmira. G.K. Abou-Alfa: Self consulting role: Agios, Amgen, Antengene, Aptus, Aslan, Astellas, AstraZeneca, Bayer, BMS, Boston Scientifc, Carsgen, Celgene, Casi, Daiichi, Debio, Delcath, Eisai, Exelixis, Halozyme, Inovio, Ipsen, Merck, Onxeo, PCI Biotech, Roche, Sanofi, Servier, Sillajen, Sirtex, Yakult Immediate; Family member consulting: Celgene, CytomX, Gilead, Halozyme, Sanofi, Silenseed; Institutional Research; Agios, Array, AstraZeneca, Bayer, BMS, Casi, Celgene, Exelixis, Genentech, Incyte, Lilly, Mabvax, Medimmune, Momenta, Novartis, OncoMed Pharmaceuticals, Roche. All other authors have declared no conflicts of interest.

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