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

doi:10.1007/s00432-018-2780-8

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

^*Corresponding author for this work

Clinic of Internal Medicine I

38 Citations (Scopus)

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.

Original language	English
Journal	Journal of Cancer Research and Clinical Oncology
Volume	145
Issue number	1
Pages (from-to)	253-259
Number of pages	7
ISSN	0171-5216
DOIs	https://doi.org/10.1007/s00432-018-2780-8
Publication status	Published - 22.01.2019

Funding

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, Sa-nofi, 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,

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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Finkelmeier, F., Czauderna, C., Perkhofer, L., Ettrich, T. J., Trojan, J., Weinmann, A., Marquardt, J. U., Vermehren, J., & Waidmann, O. (2019). Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers. Journal of Cancer Research and Clinical Oncology, 145(1), 253-259. https://doi.org/10.1007/s00432-018-2780-8

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

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{\textquoteright}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.",

author = "Fabian Finkelmeier and Carolin Czauderna and Lukas Perkhofer and Ettrich, \{Thomas J.\} and J{\"o}rg Trojan and Arndt Weinmann and Marquardt, \{Jens U.\} and Johannes Vermehren and Oliver Waidmann",

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Finkelmeier, F, Czauderna, C, Perkhofer, L, Ettrich, TJ, Trojan, J, Weinmann, A, Marquardt, JU, Vermehren, J & Waidmann, O 2019, 'Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers', Journal of Cancer Research and Clinical Oncology, vol. 145, no. 1, pp. 253-259. https://doi.org/10.1007/s00432-018-2780-8

TY - JOUR

T1 - Feasibility and safety of nivolumab in advanced hepatocellular carcinoma: real-life experience from three German centers

AU - Finkelmeier, Fabian

AU - Czauderna, Carolin

AU - Perkhofer, Lukas

AU - Ettrich, Thomas J.

AU - Trojan, Jörg

AU - Weinmann, Arndt

AU - Marquardt, Jens U.

AU - Vermehren, Johannes

AU - Waidmann, Oliver

PY - 2019/1/22

Y1 - 2019/1/22

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85056004442

U2 - 10.1007/s00432-018-2780-8

DO - 10.1007/s00432-018-2780-8

M3 - Journal articles

C2 - 30374657

AN - SCOPUS:85056004442

SN - 0171-5216

VL - 145

SP - 253

EP - 259

JO - Journal of Cancer Research and Clinical Oncology

JF - Journal of Cancer Research and Clinical Oncology

IS - 1

ER -

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

Abstract

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