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Journal of Cancer Research and Clinical Oncology

, Volume 145, Issue 1, pp 253–259 | Cite as

Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers

  • Fabian Finkelmeier
  • Carolin Czauderna
  • Lukas Perkhofer
  • Thomas J. Ettrich
  • Jörg Trojan
  • Arndt Weinmann
  • Jens U. Marquardt
  • Johannes Vermehren
  • Oliver Waidmann
Original Article – Clinical Oncology
  • 229 Downloads

Abstract

Introduction

Nivolumab is the first checkpoint-inhibitor approved for the treatment of advanced HCC patients. Real-life experience data of nivolumab treatment in HCC patients, especially those with advanced liver disease, is scarce.

Materials and methods

All patients with confirmed advanced HCC and nivolumab treatment from three large German centers were retrospectively analyzed. Clinical parameters and outcome were assessed.

Results

A total of 34 patients were included. At the time of treatment initiation 5 patients (14.7%) were classified as stage BCLC B and 29 (85.3%) BCLC C, respectively. 25 (73.5) patients had received prior sorafenib treatment. All patients presented with cirrhosis, namely Child–Pugh stages A (56%) or B (41%), respectively. At time of patient’s assessment, 20 out of 34 (58.8%) patients had died. Grade 3 toxicities occurred in two patients (5.9%). Best overall responses were partial response in four patients (11.8%) and stable disease in eight patients (23.5%). The median overall survival of the whole cohort was 7.5 weeks (range 0–46). Child–Pugh B stage disease at treatment start was significantly associated with poor outcome.

Discussion

Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.

Keywords

HCC Immunotherapy Nivolumab Cirrhosis Liver function 

Abbreviations

ALBI

Albumin–Bilirubin grade

HBV

Hepatitis B virus

HCV

Hepatitis C virus

CR

Complete response

CT

Computed tomography

CTCAE

Common toxicity criteria

BCLC

Barcelona clinic liver cancer staging

EMA

European Medicines Agency

FDA

United States Food and Drug Administration

HCC

Hepatocellular carcinoma

MELD

Model of end-stage liver disease

MRI

Magnetic resonance imaging

NASH

Non-alcoholic steatohepatitis

PD

Progressive disease

PD-1

Programmed cell death protein 1

PR

Partial response

OS

Overall survival

SD

Stable disease

TACE

Transarterial chemoembolisation

TKI

Tyrosinkinase-inhibitor

Notes

Funding

None.

Compliance with ethical standards

Conflict of interest

Fabian Finkelmeier received travel grants from AbbVie outside the submitted work. Carolin Czauderna has nothing to report. Lukas Perkhofer received travel grants from Ipsen, Bayer, Sanofi, Novartis outside the submitted work. Thomas J. Ettrich received travel grants from Ipsen outside the submitted work. He acted as consultant for Bayer, BMS, Sanofi, Merck Serono, Roche and Pfizer outside the submitted work. He received lecture fees from Merck Serono, Sanofi, Celgene. One of his research projects is supported by Shire. Jörg Trojan reports personal fees from Amgen, Bayer Healthcare, Bristol Myers-Squibb, Daichi Sankyo, Eisai, Ipsen, Merck Serono, Merck Sharp & Dome, Lilly ImClone, Roche, Shire and research grants from Roche. Arndt Weinmann has nothing to report. Jens Marquardt received honoraria from Roche and Bayer outside the submitted work. Johannes Vermehren reports personal fees from AbbVie, Gilead and MSD outside the submitted work. Oliver Waidmann received travel grants from Abbvie, Bayer, BMS, Gilead, Ipsen, Medac, Novartis, and Servier outside the submitted work. He acted as consultant for Amgen, Bayer, BMS, Celgene, Eisai, Merck, Novartis, Roche, Servier, Shire outside the submitted work. He received lecture fees from Bayer, BMS, Celgene, Ipsen, Novartis, Roche, and Shire.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards (approval numbers: Mainz 837.199.10(7208), Frankfurt SGI-11-2017, Ulm 317/12, 230/14, 128/15).

Informed consent

Written informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Fabian Finkelmeier
    • 1
  • Carolin Czauderna
    • 2
  • Lukas Perkhofer
    • 3
  • Thomas J. Ettrich
    • 3
  • Jörg Trojan
    • 1
  • Arndt Weinmann
    • 2
  • Jens U. Marquardt
    • 2
  • Johannes Vermehren
    • 1
  • Oliver Waidmann
    • 1
  1. 1.Department of Gastroenterology, Hepatology and EndocrinologyUniversity Hospital FrankfurtFrankfurtGermany
  2. 2.Department of Gastroenterology and HepatologyUniversity Hospital MainzMainzGermany
  3. 3.Medical Clinic IUniversity Hospital UlmUlmGermany

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