PAGE-B

A risk score for hepatocellular carcinoma in Caucasians with chronic hepatitis B under a 5-year entecavir or tenofovir therapy

George Papatheodoridis, George Dalekos, Vana Sypsa, Cihan Yurdaydin, Maria Buti, John Goulis, Jose Luis Calleja, Heng Chi, Spilios Manolakopoulos, Giampaolo Mangia, Nikolaos Gatselis, Onur Keskin, Savvoula Savvidou, Juan de la Revilla, Bettina E. Hansen, Ioannis Vlachogiannakos, Kostantinos Galanis, Ramazan Idilman, Massimo Colombo, Rafael Esteban & 2 others Harry L A Janssen, Pietro Lampertico

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

Background & Aims: Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods: We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ≥12months. Using data from eight centers (derivation dataset, n=1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n=490) for external validation. Results: The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B 17 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset. Conclusion: PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir.

Original languageEnglish
JournalJournal of Hepatology
DOIs
Publication statusAccepted/In press - Jun 30 2015

Fingerprint

Tenofovir
Chronic Hepatitis B
Hepatocellular Carcinoma
Blood Platelets
Therapeutics
Fibrosis
entecavir
Incidence
Proportional Hazards Models

Keywords

  • Entecavir
  • Hepatitis B
  • Hepatocellular carcinoma
  • Tenofovir

ASJC Scopus subject areas

  • Hepatology

Cite this

PAGE-B : A risk score for hepatocellular carcinoma in Caucasians with chronic hepatitis B under a 5-year entecavir or tenofovir therapy. / Papatheodoridis, George; Dalekos, George; Sypsa, Vana; Yurdaydin, Cihan; Buti, Maria; Goulis, John; Calleja, Jose Luis; Chi, Heng; Manolakopoulos, Spilios; Mangia, Giampaolo; Gatselis, Nikolaos; Keskin, Onur; Savvidou, Savvoula; de la Revilla, Juan; Hansen, Bettina E.; Vlachogiannakos, Ioannis; Galanis, Kostantinos; Idilman, Ramazan; Colombo, Massimo; Esteban, Rafael; Janssen, Harry L A; Lampertico, Pietro.

In: Journal of Hepatology, 30.06.2015.

Research output: Contribution to journalArticle

Papatheodoridis, G, Dalekos, G, Sypsa, V, Yurdaydin, C, Buti, M, Goulis, J, Calleja, JL, Chi, H, Manolakopoulos, S, Mangia, G, Gatselis, N, Keskin, O, Savvidou, S, de la Revilla, J, Hansen, BE, Vlachogiannakos, I, Galanis, K, Idilman, R, Colombo, M, Esteban, R, Janssen, HLA & Lampertico, P 2015, 'PAGE-B: A risk score for hepatocellular carcinoma in Caucasians with chronic hepatitis B under a 5-year entecavir or tenofovir therapy', Journal of Hepatology. https://doi.org/10.1016/j.jhep.2015.11.035
Papatheodoridis, George ; Dalekos, George ; Sypsa, Vana ; Yurdaydin, Cihan ; Buti, Maria ; Goulis, John ; Calleja, Jose Luis ; Chi, Heng ; Manolakopoulos, Spilios ; Mangia, Giampaolo ; Gatselis, Nikolaos ; Keskin, Onur ; Savvidou, Savvoula ; de la Revilla, Juan ; Hansen, Bettina E. ; Vlachogiannakos, Ioannis ; Galanis, Kostantinos ; Idilman, Ramazan ; Colombo, Massimo ; Esteban, Rafael ; Janssen, Harry L A ; Lampertico, Pietro. / PAGE-B : A risk score for hepatocellular carcinoma in Caucasians with chronic hepatitis B under a 5-year entecavir or tenofovir therapy. In: Journal of Hepatology. 2015.
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abstract = "Background & Aims: Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods: We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ≥12months. Using data from eight centers (derivation dataset, n=1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n=490) for external validation. Results: The 5-year cumulative HCC incidence rates were 5.7{\%} and 8.4{\%} in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B 17 had 5-year cumulative HCC incidence rates of 0{\%}, 3{\%}, 17{\%} in the derivation and 0{\%}, 4{\%}, 16{\%} in the validation dataset. Conclusion: PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir.",
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T2 - A risk score for hepatocellular carcinoma in Caucasians with chronic hepatitis B under a 5-year entecavir or tenofovir therapy

AU - Papatheodoridis, George

AU - Dalekos, George

AU - Sypsa, Vana

AU - Yurdaydin, Cihan

AU - Buti, Maria

AU - Goulis, John

AU - Calleja, Jose Luis

AU - Chi, Heng

AU - Manolakopoulos, Spilios

AU - Mangia, Giampaolo

AU - Gatselis, Nikolaos

AU - Keskin, Onur

AU - Savvidou, Savvoula

AU - de la Revilla, Juan

AU - Hansen, Bettina E.

AU - Vlachogiannakos, Ioannis

AU - Galanis, Kostantinos

AU - Idilman, Ramazan

AU - Colombo, Massimo

AU - Esteban, Rafael

AU - Janssen, Harry L A

AU - Lampertico, Pietro

PY - 2015/6/30

Y1 - 2015/6/30

N2 - Background & Aims: Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods: We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ≥12months. Using data from eight centers (derivation dataset, n=1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n=490) for external validation. Results: The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B 17 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset. Conclusion: PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir.

AB - Background & Aims: Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods: We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ≥12months. Using data from eight centers (derivation dataset, n=1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n=490) for external validation. Results: The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B 17 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset. Conclusion: PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir.

KW - Entecavir

KW - Hepatitis B

KW - Hepatocellular carcinoma

KW - Tenofovir

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