External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B
Background and Aims: The liver cancer risk test (LCR1-LCR2) is a multianalyte blood test combining proteins involved in liver cell repair (apolipoprotein A1, haptoglobin), hepatocellular carcinoma (HCC) risk factors (gender, age, gamma glutamyl transpeptidase), a marker of fibrosis (alpha2-macroglob...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-01-01
|
| Series: | Gastro Hep Advances |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772572322000231 |
| _version_ | 1818549791313887232 |
|---|---|
| author | Thierry Poynard Jean Marc Lacombe Olivier Deckmyn Valentina Peta Sepideh Akhavan Fabien Zoulim Victor de Ledinghen Didier Samuel Philippe Mathurin Vlad Ratziu Dominique Thabut Chantal Housset Hélène Fontaine Stanislas Pol Fabrice Carrat |
| author_facet | Thierry Poynard Jean Marc Lacombe Olivier Deckmyn Valentina Peta Sepideh Akhavan Fabien Zoulim Victor de Ledinghen Didier Samuel Philippe Mathurin Vlad Ratziu Dominique Thabut Chantal Housset Hélène Fontaine Stanislas Pol Fabrice Carrat |
| author_sort | Thierry Poynard |
| collection | DOAJ |
| description | Background and Aims: The liver cancer risk test (LCR1-LCR2) is a multianalyte blood test combining proteins involved in liver cell repair (apolipoprotein A1, haptoglobin), hepatocellular carcinoma (HCC) risk factors (gender, age, gamma glutamyl transpeptidase), a marker of fibrosis (alpha2-macroglobulin), and alpha-fetoprotein, a specific marker of HCC. The aim was to externally validate LCR1-LCR2 in hepatitis B. Methods: Preincluded patients were from the Hepather cohort, a multicenter, multiethnic prospective study in 6071 patients. The coprimary study outcome was the negative predictive value of LCR1-LCR2 at 5 years for the occurrence of HCC and survival without HCC according to the predetermined LCR1-LCR2 cutoffs, adjusted for risk covariables and for chronic hepatitis B treatment and quantified using time-dependent Cox proportional hazards models. A post hoc analysis compared the number of patients needed to screen one cancer by LCR1-LCR2 and PAGE-B. Results: A total of 3520 patients, 191 (5.4%) with cirrhosis, with at least 1 year of follow-up were included. A total of 76 HCCs occurred over a median (interquartile range) of 6.0 years (4.8–7.3) of follow-up. Among the 3367 patients with low-risk LCR1-LCR2, the 5-year negative predictive value was 99.3% (95% confidence interval = 99.0–99.6), with a significant Cox hazard ratio (6.4, 3.1–13.0; P < .001) obtained after adjustment for exposure to antivirals, age, gender, geographical origin, HBe-Ag status, alcohol consumption, and type-2 diabetes. LCR1-LCR2 outperformed PAGE-B for number of patients needed to screen mean (95% CI), 8.5 (3.2–8.1) vs 26.3 (17.5–38.5; P < .0001), respectively. Conclusion: The performance of LCR1-LCR2 to identify patients with chronic hepatitis B at very low risk of HCC at 5 years was externally validated. ClinicalTrials.gov: NCT01953458. |
| first_indexed | 2024-12-12T08:37:52Z |
| format | Article |
| id | doaj.art-fe0797793ffb4609867fca065acaaac8 |
| institution | Directory Open Access Journal |
| issn | 2772-5723 |
| language | English |
| last_indexed | 2024-12-12T08:37:52Z |
| publishDate | 2022-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Gastro Hep Advances |
| spelling | doaj.art-fe0797793ffb4609867fca065acaaac82022-12-22T00:30:52ZengElsevierGastro Hep Advances2772-57232022-01-0114604617External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis BThierry Poynard0Jean Marc Lacombe1Olivier Deckmyn2Valentina Peta3Sepideh Akhavan4Fabien Zoulim5Victor de Ledinghen6Didier Samuel7Philippe Mathurin8Vlad Ratziu9Dominique Thabut10Chantal Housset11Hélène Fontaine12Stanislas Pol13Fabrice Carrat14Department of Hepato-Gastroenterology, Assistance Publique-Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Paris, France; INSERM, Centre de Recherche Saint-Antoine (CRSA), Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Université, Paris, France; Correspondence: Address correspondence to: Thierry Poynard, MD, PhD, Groupe Hospitalier Pitie-Salpetriere, Service d'Hepato Gastroenterologie, 47 Boulevard de l'Hopital, Paris Cedex 13, Paris 75651, France.INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique, Sorbonne Université, Paris, FranceResearch Unit, BioPredictive, Paris, FranceINSERM, Centre de Recherche Saint-Antoine (CRSA), Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Université, Paris, France; Research Unit, BioPredictive, Paris, FranceDepartment of Hepato-Gastroenterology, Assistance Publique-Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Paris, FranceHepatology Unit Hôpital Haut-Lévêque, Pessac, and INSERM U1053, Université Bordeaux Segalen, Bordeaux, FranceDepartment of Hepatology, Hospices civils de Lyon, Hôpital Croix Rousse, INSERM U1052, Université de Lyon, Lyon, FranceHepatology Department, AP-HP, Hospital Paul Brousse, UMR-S1193, Villejuif, Université Paris-Saclay, and Hepatinov, Villejuif, FranceHepatology Department, CHRU Claude Huriez, Lille, FranceDepartment of Hepato-Gastroenterology, Assistance Publique-Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Paris, France; INSERM, Centre de Recherche Saint-Antoine (CRSA), Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Université, Paris, FranceDepartment of Hepato-Gastroenterology, Assistance Publique-Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Paris, France; INSERM, Centre de Recherche Saint-Antoine (CRSA), Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Université, Paris, FranceINSERM, Centre de Recherche Saint-Antoine (CRSA), Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Université, Paris, FranceAssistance Publique-Hôpitaux de Paris (AP-HP), Department of Hepato-Gastroenterology, AP-HP, Hôpital Cochin, Hepatology Department, Paris, FranceAssistance Publique-Hôpitaux de Paris (AP-HP), Department of Hepato-Gastroenterology, AP-HP, Hôpital Cochin, Hepatology Department, Paris, FranceINSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique, Sorbonne Université, Paris, FranceBackground and Aims: The liver cancer risk test (LCR1-LCR2) is a multianalyte blood test combining proteins involved in liver cell repair (apolipoprotein A1, haptoglobin), hepatocellular carcinoma (HCC) risk factors (gender, age, gamma glutamyl transpeptidase), a marker of fibrosis (alpha2-macroglobulin), and alpha-fetoprotein, a specific marker of HCC. The aim was to externally validate LCR1-LCR2 in hepatitis B. Methods: Preincluded patients were from the Hepather cohort, a multicenter, multiethnic prospective study in 6071 patients. The coprimary study outcome was the negative predictive value of LCR1-LCR2 at 5 years for the occurrence of HCC and survival without HCC according to the predetermined LCR1-LCR2 cutoffs, adjusted for risk covariables and for chronic hepatitis B treatment and quantified using time-dependent Cox proportional hazards models. A post hoc analysis compared the number of patients needed to screen one cancer by LCR1-LCR2 and PAGE-B. Results: A total of 3520 patients, 191 (5.4%) with cirrhosis, with at least 1 year of follow-up were included. A total of 76 HCCs occurred over a median (interquartile range) of 6.0 years (4.8–7.3) of follow-up. Among the 3367 patients with low-risk LCR1-LCR2, the 5-year negative predictive value was 99.3% (95% confidence interval = 99.0–99.6), with a significant Cox hazard ratio (6.4, 3.1–13.0; P < .001) obtained after adjustment for exposure to antivirals, age, gender, geographical origin, HBe-Ag status, alcohol consumption, and type-2 diabetes. LCR1-LCR2 outperformed PAGE-B for number of patients needed to screen mean (95% CI), 8.5 (3.2–8.1) vs 26.3 (17.5–38.5; P < .0001), respectively. Conclusion: The performance of LCR1-LCR2 to identify patients with chronic hepatitis B at very low risk of HCC at 5 years was externally validated. ClinicalTrials.gov: NCT01953458.http://www.sciencedirect.com/science/article/pii/S2772572322000231Fibrosis ProgressionCirrhosisLCR1-LCR2FibroTest |
| spellingShingle | Thierry Poynard Jean Marc Lacombe Olivier Deckmyn Valentina Peta Sepideh Akhavan Fabien Zoulim Victor de Ledinghen Didier Samuel Philippe Mathurin Vlad Ratziu Dominique Thabut Chantal Housset Hélène Fontaine Stanislas Pol Fabrice Carrat External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B Gastro Hep Advances Fibrosis Progression Cirrhosis LCR1-LCR2 FibroTest |
| title | External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B |
| title_full | External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B |
| title_fullStr | External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B |
| title_full_unstemmed | External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B |
| title_short | External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B |
| title_sort | external validation of lcr1 lcr2 a multivariable hepatocellular carcinoma risk calculator in a multiethnic cohort of patients with chronic hepatitis b |
| topic | Fibrosis Progression Cirrhosis LCR1-LCR2 FibroTest |
| url | http://www.sciencedirect.com/science/article/pii/S2772572322000231 |
| work_keys_str_mv | AT thierrypoynard externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT jeanmarclacombe externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT olivierdeckmyn externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT valentinapeta externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT sepidehakhavan externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT fabienzoulim externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT victordeledinghen externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT didiersamuel externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT philippemathurin externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT vladratziu externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT dominiquethabut externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT chantalhousset externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT helenefontaine externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT stanislaspol externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb AT fabricecarrat externalvalidationoflcr1lcr2amultivariablehepatocellularcarcinomariskcalculatorinamultiethniccohortofpatientswithchronichepatitisb |