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Multicenter Study
. 2019 Jan;145(1):253-259.
doi: 10.1007/s00432-018-2780-8. Epub 2018 Oct 29.

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

Fabian Finkelmeier  1 , Carolin Czauderna  2 , Lukas Perkhofer  3 , Thomas J Ettrich  3 , Jörg Trojan  4 , Arndt Weinmann  2 , Jens U Marquardt  2 , Johannes Vermehren  4 , Oliver Waidmann  4
Affiliations
Multicenter Study

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

Fabian Finkelmeier et al. J Cancer Res Clin Oncol. 2019 Jan.

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: Cirrhosis; HCC; Immunotherapy; Liver function; Nivolumab.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
a Overall survival curve (Kaplan–Meier estimator) of patients treated with nivolumab. b Overall survival of patients with hepatocellular carcinoma stratified by BCLC stage (p = 0.126, by log-rank test). c Overall survival of patients with hepatocellular carcinoma stratified by Child–Pugh stage (p < 0.001, by log-rank test). d Overall survival of patients with hepatocellular carcinoma stratified by previous sorafenib treatment (p = 0.186, by log-rank test)
See this image and copyright information in PMC

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