PMID- 34414124
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220425
IS  - 2235-1795 (Print)
IS  - 1664-5553 (Electronic)
IS  - 1664-5553 (Linking)
VI  - 10
IP  - 4
DP  - 2021 Jul
TI  - Real-Life Clinical Data of Cabozantinib for Unresectable Hepatocellular 
      Carcinoma.
PG  - 370-379
LID - 10.1159/000515551 [doi]
AB  - INTRODUCTION: Cabozantinib has been approved by the European Medicine Agency 
      (EMA) for hepatocellular carcinoma (HCC) previously treated with sorafenib. 
      Cabozantinib is also being tested in combination with immune checkpoint 
      inhibitors in the frontline setting. Real-life clinical data of cabozantinib for 
      HCC are still lacking. Moreover, the prognostic factors for HCC treated with 
      cabozantinib have not been investigated. METHODS: We evaluated clinical data and 
      outcome of HCC patients who received cabozantinib in the legal context of named 
      patient use in Italy. RESULTS: Ninety-six patients from 15 centres received 
      cabozantinib. All patients had preserved liver function (Child-Pugh A), mostly 
      with an advanced HCC (77.1%) in a third-line setting (75.0%). The prevalence of 
      performance status (PS) > 0, macrovascular invasion (MVI), extrahepatic spread, 
      and alpha-fetoprotein (AFP) >400 ng/mL was 50.0, 30.2, 67.7, and 44.8%, 
      respectively. Median overall survival (OS) and progression-free survival were 
      12.1 (95% confidence interval 9.4-14.8) and 5.1 (3.3-6.9) months, respectively. 
      Most common treatment-related adverse events (AEs) were fatigue (67.7%), 
      diarrhoea (54.2%), anorexia (45.8%), HFSR (43.8%), weight loss (24.0%), and 
      hypertension (24.0%). Most common treatment-related Grade 3-4 AEs were fatigue 
      (6.3%), HFSR (6.3%), and increased aminotransferases (6.3%). MVI, ECOG-PS > 0, 
      and AFP >400 ng/mL predicted a worse OS. Discontinuation for intolerance and no 
      new extrahepatic lesions at the progression were associated with better outcomes. 
      CONCLUSIONS: In a real-life Western scenario (mostly in a third-line setting), 
      cabozantinib efficacy and safety data were comparable with those reported in its 
      registration trial. Data regarding the prognostic factors might help in patient 
      selection and design of clinical trials.
CI  - Copyright (c) 2021 by S. Karger AG, Basel.
FAU - Tovoli, Francesco
AU  - Tovoli F
AD  - Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS 
      Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
FAU - Dadduzio, Vincenzo
AU  - Dadduzio V
AD  - Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padova, Italy.
FAU - De Lorenzo, Stefania
AU  - De Lorenzo S
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
FAU - Rimassa, Lorenza
AU  - Rimassa L
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, 
      Italy.
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas 
      Research Hospital, Rozzano, Milan, Italy.
FAU - Masi, Gianluca
AU  - Masi G
AD  - Department of Medical Oncology, Pisa University Hospital, Pisa, Italy.
FAU - Iavarone, Massimo
AU  - Iavarone M
AD  - Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale 
      Maggiore Policlinico, Milan, Italy.
FAU - Marra, Fabio
AU  - Marra F
AD  - Department of Experimental and Clinical Medicine, University of Florence, 
      Florence, Italy.
FAU - Garajova, Ingrid
AU  - Garajova I
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
FAU - Brizzi, Maria Pia
AU  - Brizzi MP
AD  - Medical Oncology Unit, A.O.U. S. Luigi Gonzaga, Orbassano, Italy.
FAU - Daniele, Bruno
AU  - Daniele B
AD  - U.O.C. Oncologia, Ospedale del Mare, Napoli, Italy.
FAU - Trevisani, Franco
AU  - Trevisani F
AD  - Semeiotica Medica, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna, Bologna, 
      Italy.
FAU - Messina, Carlo
AU  - Messina C
AD  - Oncology Unit, Santa Chiara Hospital, Trento, Italy.
FAU - Di Clemente, Francesco
AU  - Di Clemente F
AD  - Unita Operativa Semplice Dipartimentale (UOSD) "Oncologia medica" del Valdarno, 
      Montevarchi, Italy.
FAU - Pini, Sara
AU  - Pini S
AD  - Division of Oncology, AUSL Romagna, Rimini, Italy.
FAU - Cabibbo, Giuseppe
AU  - Cabibbo G
AD  - Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences 
      Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, 
      University of Palermo, Palermo, Italy.
FAU - Granito, Alessandro
AU  - Granito A
AD  - Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS 
      Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna, Bologna, 
      Italy.
FAU - Rizzato, Mario Domenico
AU  - Rizzato MD
AD  - Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padova, Italy.
AD  - Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, 
      Italy.
FAU - Zagonel, Vittorina
AU  - Zagonel V
AD  - Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padova, Italy.
FAU - Brandi, Giovanni
AU  - Brandi G
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
FAU - Pressiani, Tiziana
AU  - Pressiani T
AD  - Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas 
      Research Hospital, Rozzano, Milan, Italy.
FAU - Federico, Piera
AU  - Federico P
AD  - U.O.C. Oncologia, Ospedale del Mare, Napoli, Italy.
FAU - Vivaldi, Caterina
AU  - Vivaldi C
AD  - Department of Medical Oncology, Pisa University Hospital, Pisa, Italy.
FAU - Bergna, Irene
AU  - Bergna I
AD  - Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale 
      Maggiore Policlinico, Milan, Italy.
FAU - Campani, Claudia
AU  - Campani C
AD  - Department of Experimental and Clinical Medicine, University of Florence, 
      Florence, Italy.
FAU - Piscaglia, Fabio
AU  - Piscaglia F
AD  - Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS 
      Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna, Bologna, 
      Italy.
LA  - eng
PT  - Journal Article
DEP - 20210615
PL  - Switzerland
TA  - Liver Cancer
JT  - Liver cancer
JID - 101597993
PMC - PMC8339460
OTO - NOTNLM
OT  - Cabozantinib
OT  - Hepatocellular carcinoma
OT  - Outcome
OT  - Sorafenib
OT  - Tyrosine kinase inhibitors
COIS- F.To.: consultant for Bayer; advisory board for Guerbet. V.D.: personal fees from 
      Bayer, MSD, Eisai, and Ipsen. L.R.: consulting fees from Amgen, ArQule, 
      AstraZeneca, Basilea, Bayer, Celgene, Eisai, Exelixis, Hengrui, Incyte, Ipsen, 
      Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi; lectures fees from AbbVie, 
      Amgen, Eisai, Gilead, Incyte, Ipsen, Lilly, Roche, Sanofi; travel fees from 
      Ipsen; and institutional research funding from Agios, ARMO BioSciences, 
      AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, and 
      Roche. M.I.: speaking and teaching for Bayer, Gilead Science, Janssen, BTG, 
      AbbVie; consultant for BCG; Editorial Board Member of Liver Cancer. F.M.: 
      consultant for Bayer and Ipsen, travel grants from Bayer. B.D.: honoraria from 
      Ipsen, AstraZeneca, Incyte, Lilly, Eisai, Bayer, Roche, and MSD. F.Tr.: advisory 
      board for Bayer, Alfasigma, Bristol-Myers Squibb, and Sirtex. G.C.: advisory 
      board for Bayer; V.Z.: advisory board for Bristol-Myers Squibb and Merck; 
      speakers' bureau for AstraZeneca and Lilly; personal fees from Bayer, Roche, and 
      Servier. G.B.: advisory board for Eli Lilly and MSD. T.P. institutional research 
      funding from Eli Lilly. F.P.: consultant for Astrazeneca, Bayer AG, EISAI, GE, 
      and Tiziana life sciences; speaker's bureau honoraria from Bayer AG, Bracco, 
      EISAI, and Laforce; and research contract with Esaote; Massimo Iavarone and Fabio 
      Piscaglia are Editorial Board Members of Liver Cancer. The remaining authors 
      declared no conflict of interests.
EDAT- 2021/08/21 06:00
MHDA- 2021/08/21 06:01
PMCR- 2021/06/15
CRDT- 2021/08/20 07:06
PHST- 2020/11/19 00:00 [received]
PHST- 2021/02/27 00:00 [accepted]
PHST- 2021/08/20 07:06 [entrez]
PHST- 2021/08/21 06:00 [pubmed]
PHST- 2021/08/21 06:01 [medline]
PHST- 2021/06/15 00:00 [pmc-release]
AID - lic-0010-0370 [pii]
AID - 10.1159/000515551 [doi]
PST - ppublish
SO  - Liver Cancer. 2021 Jul;10(4):370-379. doi: 10.1159/000515551. Epub 2021 Jun 15.