Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers
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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.
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.
Nivolumab treatment seems safe and clinical efficacious. Patients with advanced liver disease require further prospective evaluation due to probable limited efficacy of nivolumab.
KeywordsHCC Immunotherapy Nivolumab Cirrhosis Liver function
Hepatitis B virus
Hepatitis C virus
Common toxicity criteria
Barcelona clinic liver cancer staging
European Medicines Agency
United States Food and Drug Administration
Model of end-stage liver disease
Magnetic resonance imaging
Programmed cell death protein 1
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.
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).
Written informed consent was obtained from all individual participants included in the study.
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