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J Hepatol. 2014 Aug;61(2):333-41. doi: 10.1016/j.jhep.2014.03.037. Epub 2014 Apr 6.

Estimation of lead-time bias and its impact on the outcome of surveillance for the early diagnosis of hepatocellular carcinoma.

Author information

1
Dipartimento di Scienze Mediche e Chirurgiche, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum - Università of Bologna, Italy. Electronic address: aleqko@libero.it.
2
Dipartimento di Scienze Mediche e Chirurgiche, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum - Università of Bologna, Italy.
3
Dipartimento di Scienze Chirurgiche e Gastroenterologiche, Unità di Gastroenterologia, Università di Padova, Padova, Italy.
4
Divisione di Chirurgia, Policlinico San Marco, Zingonia, Italy.
5
Unità di Medicina Interna e Gastroenterologia, Complesso Integrato Columbus, Università Cattolica di Roma, Roma, Italy.
6
Divisione di Medicina, Azienda Ospedaliera Bolognini, Seriate, Italy.
7
Unità Operativa di Gastroenterologia, Ospedale Belcolle, Viterbo, Italy.
8
Dipartimento di Medicina Interna, Unità di Gastroenterologia, Università di Genova, Genova, Italy.
9
Dipartimento di Medicina, Unità di Radiologia, Ospedale Fatebenefratelli, Milano, Italy.
10
Dipartimento Biomedico di Medicina Interna e Specialistica, Unità di Gastroenterologia, Università di Palermo, Palermo, Italy.
11
Ospedale Regionale di Bolzano, Unità di Gastroenterologia, Bolzano, Italy.
12
Unità di Medicina Interna e Gastroenterologia, Policlinico Gemelli, Università Cattolica di Roma, Roma, Italy.
13
Unità Operativa Gastroenterologia e Malattie del Ricambio, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
14
Unità di Medicina Interna, Presidio Ospedaliero di Faenza, Faenza, Italy.
15
Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
16
Dipartimento di Medicina Clinica e Chirurgia, Unità di Gastroenterologia, Università di Napoli "Federico II", Napoli, Italy.
17
Clinica di Gastroenterologia, Università Politecnica delle Marche, Ancona, Italy.
18
Dipartimento Biomedico di Medicina Interna e Specialistica, Unità di Medicina Interna, Palermo, Italy.

Abstract

BACKGROUND & AIMS:

Lead-time is the time by which diagnosis is anticipated by screening/surveillance with respect to the symptomatic detection of a disease. Any screening program, including surveillance for hepatocellular carcinoma (HCC), is subject to lead-time bias. Data regarding lead-time for HCC are lacking. Aims of the present study were to calculate lead-time and to assess its impact on the benefit obtainable from the surveillance of cirrhotic patients.

METHODS:

One-thousand three-hundred and eighty Child-Pugh class A/B patients from the ITA.LI.CA database, in whom HCC was detected during semiannual surveillance (n = 850), annual surveillance (n = 234) or when patients came when symptomatic (n = 296), were selected. Lead-time was estimated by means of appropriate formulas and Monte Carlo simulation, including 1000 patients for each arm.

RESULTS:

The 5-year overall survival after HCC diagnosis was 32.7% in semiannually surveilled patients, 25.2% in annually surveilled patients, and 12.2% in symptomatic patients (p<0.001). In a 10-year follow-up perspective, the median lead-time calculated for all surveilled patients was 6.5 months (7.2 for semiannual and 4.1 for annual surveillance). Lead-time bias accounted for most of the surveillance benefit until the third year of follow-up after HCC diagnosis. However, even after lead-time adjustment, semiannual surveillance maintained a survival benefit over symptomatic diagnosis (number of patients needed to screen = 13), as did annual surveillance (18 patients).

CONCLUSIONS:

Lead-time bias is the main determinant of the short-term benefit provided by surveillance for HCC, but this benefit becomes factual in a long-term perspective, confirming the clinical utility of an anticipated diagnosis of HCC.

KEYWORDS:

Cirrhosis; Hepatocellular carcinoma; Lead-time bias; Surveillance

PMID:
24717522
DOI:
10.1016/j.jhep.2014.03.037
[Indexed for MEDLINE]
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