Scheiner, Bernhard ORCID: 0000-0002-4904-5133, Pomej, Katharina ORCID: 0000-0002-2807-3565, Kirstein, Martha M., Hucke, Florian ORCID: 0000-0001-7887-3440, Finkelmeier, Fabian, Waidmann, Oliver, Himmelsbach, Vera, Schulze, Kornelius, von Felden, Johann ORCID: 0000-0003-2839-5174, Frundt, Thorben W., Stadler, Marc, Heinzl, Harald, Shmanko, Kateryna, Spahn, Stephan, Radu, Pompilia, Siebenhuener, Alexander R., Mertens, Joachim C., Rahbari, Nuh N., Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias P., Teufel, Andreas, De Dosso, Sara, Pinato, David J., Pressiani, Tiziana ORCID: 0000-0001-6919-1536, Meischl, Tobias, Balcar, Lorenz ORCID: 0000-0002-6708-3061, Mueller, Christian, Mandorfer, Mattias, Reiberger, Thomas ORCID: 0000-0002-4590-3583, Trauner, Michael ORCID: 0000-0002-1275-6425, Personeni, Nicola ORCID: 0000-0002-7995-272X, Rimassa, Lorenza ORCID: 0000-0001-9957-3615, Bitzer, Michael ORCID: 0000-0002-4463-8263, Trojan, Joerg, Weinmann, Arndt, Wege, Henning, Dufour, Jean-Francois, Peck-Radosavljevic, Markus, Vogel, Arndt and Pinter, Matthias (2022). Prognosis of patients with hepatocellular carcinoma treated with immunotherapy - development and validation of the CRAFITY score. J. Hepatol., 76 (2). S. 353 - 365. AMSTERDAM: ELSEVIER. ISSN 1600-0641

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Abstract

Background & Aims: Immunotherapy with atezolizumab plus bevacizumab represents the new standard of care in systemic front-line treatment of hepatocellular carcinoma (HCC). However, biomarkers that predict treatment success and survival remain an unmet need. Methods: Patients with HCC put on PD-(L)1-based immunotherapy were included in a training set (n = 190; 6 European centers) and a validation set (n = 102; 8 European centers). We investigated the prognostic value of baseline variables on overall survival using a Cox model in the training set and developed the easily applicable CRAFITY (CRP and AFP in ImmunoTherapY) score. The score was validated in the independent, external cohort, and evaluated in a cohort of patients treated with sor- afenib (n = 204). Results: Baseline serum alpha-fetoprotein >= 100 ng/ml (hazard ratio [HR] 1.7; p = 0.007) and C-reactive protein >= 1 mg/dl (HR, 1.7; p = 0.007) were identified as independent prognostic factors in multivariable analysis and were used to develop the CRAFITY score. Patients who fulfilled no criterion (0 points; CRAFITY-low) had the longest median overall survival (27.6 (95% CI 19.5-35.8) months), followed by those fulfilling 1 criterion (1 point; CRAFITY-intermediate; 11.3 (95% CI 8.0-14.6) months), and patients meeting both criteria (2 points; CRAFITY-high; 6.4 (95% CI 4.8-8.1) months; p <0.001). Additionally, best radiological response (complete response/partial response/stable disease/ progressive disease) was significantly better in patients with lower CRAFITY score (CRAFITY-low: 9%/20%/52%/20% vs. CRAFITY-intermediate: 3%/25%/36%/36% vs. CRAFITY-high: 2%/ 15%/22%/61%; p = 0.003). These results were confirmed in the independent validation set and in different subgroups, including Child-Pugh A and B, performance status 0 and >= 1 and first-line and later lines. In the sorafenib cohort, CRAFITY was associated with survival, but not radiological response. Conclusions: The CRAFITY score is associated with survival and radiological response in patients receiving PD-(L)1 immunotherapy. The score may help with patient counseling but requires prospective validation. Lay summary: The immunotherapy-based regimen of atezolizumab plus bevacizumab represents the new standard of care in systemic first-line therapy of hepatocellular carcinoma (HCC). Biomarkers to predict treatment outcome are an unmet need in patients undergoing immunotherapy for HCC. We developed and externally validated a score that predicts outcome in patients with HCC undergoing immunotherapy with immune checkpoint blockers. (C) 2021 The Author(s). Published by Elsevier B.V. on behalf of European Association for the Study of the Liver.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Scheiner, BernhardUNSPECIFIEDorcid.org/0000-0002-4904-5133UNSPECIFIED
Pomej, KatharinaUNSPECIFIEDorcid.org/0000-0002-2807-3565UNSPECIFIED
Kirstein, Martha M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hucke, FlorianUNSPECIFIEDorcid.org/0000-0001-7887-3440UNSPECIFIED
Finkelmeier, FabianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waidmann, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Himmelsbach, VeraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulze, KorneliusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Felden, JohannUNSPECIFIEDorcid.org/0000-0003-2839-5174UNSPECIFIED
Frundt, Thorben W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stadler, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinzl, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shmanko, KaterynaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spahn, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Radu, PompiliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siebenhuener, Alexander R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mertens, Joachim C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rahbari, Nuh N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuetting, FabianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waldschmidt, Dirk-ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ebert, Matthias P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Teufel, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Dosso, SaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pinato, David J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pressiani, TizianaUNSPECIFIEDorcid.org/0000-0001-6919-1536UNSPECIFIED
Meischl, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balcar, LorenzUNSPECIFIEDorcid.org/0000-0002-6708-3061UNSPECIFIED
Mueller, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mandorfer, MattiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reiberger, ThomasUNSPECIFIEDorcid.org/0000-0002-4590-3583UNSPECIFIED
Trauner, MichaelUNSPECIFIEDorcid.org/0000-0002-1275-6425UNSPECIFIED
Personeni, NicolaUNSPECIFIEDorcid.org/0000-0002-7995-272XUNSPECIFIED
Rimassa, LorenzaUNSPECIFIEDorcid.org/0000-0001-9957-3615UNSPECIFIED
Bitzer, MichaelUNSPECIFIEDorcid.org/0000-0002-4463-8263UNSPECIFIED
Trojan, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weinmann, ArndtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wege, HenningUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dufour, Jean-FrancoisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peck-Radosavljevic, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vogel, ArndtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pinter, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-697252
DOI: 10.1016/j.jhep.2021.09.035
Journal or Publication Title: J. Hepatol.
Volume: 76
Number: 2
Page Range: S. 353 - 365
Date: 2022
Publisher: ELSEVIER
Place of Publication: AMSTERDAM
ISSN: 1600-0641
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
C-REACTIVE PROTEIN; ALPHA-FETOPROTEIN; LIVER-TRANSPLANTATION; PHASE-III; CANCER; INFLAMMATION; MODELS; PERFORMANCE; RECEPTORS; MORTALITYMultiple languages
Gastroenterology & HepatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69725

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