6533b7d1fe1ef96bd125c1de
RESEARCH PRODUCT
Estimation of lead-time bias and its impact on the outcome of surveillance for the early diagnosis of hepatocellular carcinoma.
Cucchetti A.Trevisani F.Pecorelli A.Erroi V.Farinati F.Ciccarese F.Rapaccini G. L.Di Marco M.Caturelli E.Giannini E. G.Zoli M.Borzio F.Cabibbo G.Felder M.Gasbarrini A.Sacco R.Foschi F. G.Missale G.Morisco F.Baroni G. S.Virdone R.Bernardi M.Pinna A. D.Bolondi L.Biselli M.Caraceni P.Garuti F.Gramenzi A.Lenzi B.Magalotti D.Piscaglia F.Serra C.Ravaioli M.Venerandi L.Del Poggio P.Olmi S.Balsamo C.Di Nolfo M. A.Vavassori E.Alberti A.Benvegnu L.Gatta A.Giacomin A.Vanin V.Pozzan C.Maddalo G.Giampalma E.Cappelli A.Golfieri R.Mosconi C.Renzulli M.Dell'isola S.Ialungo A. M.Roselli P.Risso D.Marenco S.Sammito G.Bruzzone L.Bosco G.Grieco A.Pompili M.Rinninella E.Siciliano M.Chiaramonte M.Guarino M.Camma C.Maida M.Di Martino A.Barcellona M. R.Schiada L.Gemini S.Biasini E.Porro E.Del Ricambio M.Mismas V.Vivaldi C.subject
Malemedicine.medical_specialtyPediatricsCarcinoma HepatocellularTime FactorsHepatocellular carcinomaSettore MED/12 - GASTROENTEROLOGIADiseaseGastroenterologyBiasInternal medicineOverall survivalmedicineHumansEarly Detection of CancerAgedEstimationSurveillanceHepatologybusiness.industryLiver Neoplasmsmedicine.diseasedigestive system diseasesLead time biasCirrhosisHepatocellular carcinomaFemalebusinessLead-time biasFollow-Up Studiesdescription
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. 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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2014-01-01 |