TY - JOUR
T1 - Hepatocellular Cancer Surveillance in Patients with Advanced Chronic Liver Disease
AU - Gu, Wenyi
AU - de Lédinghen, Victor
AU - Aubé, Christophe
AU - Krag, Aleksander
AU - Strassburg, Christian
AU - Castéra, Laurent
AU - Dumortier, Jérôme
AU - Friedrich-Rust, Mireen
AU - Pol, Stanislas
AU - Grgurevic, Ivica
AU - Zeleke, Yasmin
AU - Praktiknjo, Michael
AU - Schierwagen, Robert
AU - Klein, Sabine
AU - Francque, Sven
AU - Gottfriedová, Halima
AU - Sporea, Ioan
AU - Schindler, Philipp
AU - Rennebaum, Florian
AU - Brol, Maximilian Joseph
AU - Schulz, Martin
AU - Uschner, Frank Erhard
AU - Fischer, Julia
AU - Margini, Cristina
AU - Wang, Wenping
AU - Delamarre, Adèle
AU - Best, Jan
AU - Canbay, Ali
AU - Bauer, David Josef Maria
AU - Simbrunner, Benedikt
AU - Semmler, Georg
AU - Reiberger, Thomas
AU - Boursier, Jérôme
AU - Rasmussen, Ditlev Nytoft
AU - Vilgrain, Valérie
AU - Guibal, Aymeric
AU - Zeuzem, Stefan
AU - Vassord, Camille
AU - Vonghia, Luisa
AU - Šenkeříková, Renata
AU - Popescu, Alina
AU - Berzigotti, Annalisa
AU - Laleman, Wim
AU - Thiele, Maja
AU - Jansen, Christian
AU - Trebicka, Jonel
PY - 2024/11
Y1 - 2024/11
N2 - BACKGROUND: Patients with advanced chronic liver disease (ACLD) are at high risk of developing hepatocellular carcinoma (HCC). Therefore, biannual surveillance is recommended. This large-scale multicenter study aimed to stratify the risk of HCC development in ACLD.METHODS: From 3016 patients with ACLD screened in 17 European and Chinese centers, 2340 patients with liver stiffness measurement (LSM) determined using different techniques (two-dimensional shear-wave elastography [2D-SWE], transient elastography, and point shear-wave elastography) and with different disease severities were included. Cox regression was used to explore risk factors for HCC. We used these data to create an algorithm, named PLEASE, but referred to in this manuscript as "the algorithm"; the algorithm was validated in internal and two external cohorts across elastography techniques.RESULTS: HCC developed in 127 (5.4%) patients during follow-up. LSM by 2D-SWE (hazard ratio: 2.28) was found to be associated with developing HCC, alongside age, sex, etiology, and platelet count (C-index: 0.8428). We thus established the algorithm with applicable cutoffs, assigning a maximum of six points: platelet count less than 150×10
9/l, LSM greater than or equal to 15 kPa, age greater than or equal to 50 years, male sex, controlled/uncontrolled viral hepatitis, or presence of steatotic liver diseases. Within 2 years, with a median follow-up of 13.7 months, patients in the high-risk group (≥4 points) had an HCC incidence of 15.6% (95% confidence interval [CI], 12.1% to 18.7%) compared with the low-risk group, at 1.7% (95% CI, 0.9% to 2.5%).
CONCLUSIONS: Our algorithm stratified patients into two groups: those at higher risk of developing HCC and those at lower risk. Our data provide equipoise to test the prospective utility of the algorithm with respect to clinical decisions about screening patients with ACLD for incident HCC. (Funded by the German Research Foundation and others; ClinicalTrials.gov number, NCT03389152.).
AB - BACKGROUND: Patients with advanced chronic liver disease (ACLD) are at high risk of developing hepatocellular carcinoma (HCC). Therefore, biannual surveillance is recommended. This large-scale multicenter study aimed to stratify the risk of HCC development in ACLD.METHODS: From 3016 patients with ACLD screened in 17 European and Chinese centers, 2340 patients with liver stiffness measurement (LSM) determined using different techniques (two-dimensional shear-wave elastography [2D-SWE], transient elastography, and point shear-wave elastography) and with different disease severities were included. Cox regression was used to explore risk factors for HCC. We used these data to create an algorithm, named PLEASE, but referred to in this manuscript as "the algorithm"; the algorithm was validated in internal and two external cohorts across elastography techniques.RESULTS: HCC developed in 127 (5.4%) patients during follow-up. LSM by 2D-SWE (hazard ratio: 2.28) was found to be associated with developing HCC, alongside age, sex, etiology, and platelet count (C-index: 0.8428). We thus established the algorithm with applicable cutoffs, assigning a maximum of six points: platelet count less than 150×10
9/l, LSM greater than or equal to 15 kPa, age greater than or equal to 50 years, male sex, controlled/uncontrolled viral hepatitis, or presence of steatotic liver diseases. Within 2 years, with a median follow-up of 13.7 months, patients in the high-risk group (≥4 points) had an HCC incidence of 15.6% (95% confidence interval [CI], 12.1% to 18.7%) compared with the low-risk group, at 1.7% (95% CI, 0.9% to 2.5%).
CONCLUSIONS: Our algorithm stratified patients into two groups: those at higher risk of developing HCC and those at lower risk. Our data provide equipoise to test the prospective utility of the algorithm with respect to clinical decisions about screening patients with ACLD for incident HCC. (Funded by the German Research Foundation and others; ClinicalTrials.gov number, NCT03389152.).
KW - Humans
KW - Male
KW - Liver Neoplasms/epidemiology
KW - Carcinoma, Hepatocellular/epidemiology
KW - Female
KW - Middle Aged
KW - Elasticity Imaging Techniques
KW - Aged
KW - Algorithms
KW - Risk Factors
KW - Liver Diseases/epidemiology
KW - Adult
KW - Chronic Disease
U2 - 10.1056/EVIDoa2400062
DO - 10.1056/EVIDoa2400062
M3 - Journal article
C2 - 39437136
SN - 2766-5526
VL - 3
JO - NEJM Evidence
JF - NEJM Evidence
IS - 11
M1 - EVIDoa2400062
ER -