Assessment of alpha-fetoprotein in the diagnosis of hepatocellular carcinoma in Middle Eastern patients.
ABSTRACT Alpha-fetoprotein (AFP) levels for the diagnosis of hepatocellular carcinoma (HCC) may vary by geographical region and racial background. No data exists for this test in the Middle Eastern population. In addition, there is limited data on the impact of virological status on AFP levels.
In a multicenter, case-control study involving 206 cases, 199 cirrhotic and 197 chronic hepatitis controls, we assessed the utility of AFP in the diagnosis of HCC (sensitivity, specificity, positive (PPV) and negative (NPV) predictive values, and positive likelihood ratios (LR). PPV and NPV were evaluated for three additional HCC prevalence rates (5, 10, and 20%).
The best discriminating AFP value was 11.7 ng/ml. The sensitivity ranged from 32 to 79.5% at different AFP levels with the specificity increasing sequentially from 47.7 to 98.5%. Sensitivity of AFP at the best cut-off level for hepatitis C virus (HCV), hepatitis B virus (HBV) and non-viral etiology for HCC was 73.7, 65.6, and 59.5%, respectively. Specificity at this level for HCV, HBV, and non-viral etiology was 36.6, 30.1, and 29.4%, respectively. AFP cut-off levels of 102, 200, and 400 ng/ml showed similar sensitivity (39.8, 35.9, and 32%, respectively) and specificity (96, 98.5, and 98.5% respectively). Positive LR for AFP at >11.7, >20, >102, >200, >400 ng/ml were 2.8, 3.3, 9.9, 23.8, and 21.2, respectively.
In cirrhotic patients, AFP has a poor screening and diagnostic value for HCC. Underlying viral etiology fails to influence the diagnostic accuracy of this test. An AFP level greater than 100 ng/ml has a high degree of specificity and may be used as a confirmatory test.
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ABSTRACT: The prognosis for patients with hepatocellular carcinoma (HCC) is poor because of the low chance of curative treatment. To increase the chance of intervention and to improve survival, early detection of subclinical HCC (SCHCC) by alpha-fetoprotein (AFP) and/or ultrasonography (USG) screening is implemented in many countries. Three hundred six Chinese patients with HCC diagnosed between January 1995 and December 1997 were recruited. They were categorized into two groups: 142 patients (group 1) had SCHCC diagnosed by screening (AFP and/or USG), and 164 patients (group 2) presented with symptomatic HCC. The tumor size was significantly smaller in group 1 compared with that of group 2 (3.5 cm vs. 8.1 cm; P <.0001). A significantly higher proportion of patients had bilobar involvement, multifocal HCC, diffuse-type HCC, portal vein infiltration, and distant metastasis in group 2 when compared with group 1. Operability and feasibility of treatment by transcatheter intra-arterial chemoembolization (TACE) in group 1 patients (26.8% and 45.1%, respectively) were significantly better than in group 2 patients (7.9% and 32.3%, P <.0001 and P =.03, respectively). The cumulative survival rate was significantly higher in group 1 than in group 2 (P <.0001). For those who had surgical resection and those who had TACE, group 1 patients had a higher cumulative survival rate compared with that of group 2 patients (P =.04 and P =.0003, respectively). Screening for HCC by AFP and/or USG can identify tumors at an early stage, resulting in a higher chance of receiving treatment. Whether it can improve survival requires a further prospective, randomized study.Hepatology 03/2000; 31(2):330-5. · 12.00 Impact Factor
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ABSTRACT: The authors performed a prospective trial to screen patients with chronic hepatitis B or C virus (HBV, HCV) infections to (1) determine the incidence of asymptomatic hepatocellular cancer and (2) identify the subgroups at highest risk to develop hepatocellular cancer. Four hundred sixteen patients with chronic hepatitis of more than 5 years' duration were evaluated (340 HCV, 69 HBV, 7 both). All underwent hepatic ultrasound and measurement of serum alpha-fetoprotein every 3 months. Liver biopsy was performed on entry into the study to determine the severity of hepatitis-related liver injury. Initial screening identified asymptomatic hepatocellular cancer in 33 patients (7.9%). Three additional liver cancers were detected during the 1st year of follow-up, bringing the overall incidence to 8.6%. Treatment with curative intent was possible in 22 of these patients (61.1%), whereas 14 (38.9%) had advanced disease. Thirty-five of these hepatocellular cancers occurred in a subset of 140 patients (25% incidence) with liver biopsies showing severe chronic active hepatitis, cirrhosis, or both, and one hepatocellular cancer occurred among the 276 patients (0.4%) with histologically less severe liver injury (p < 0.0001, chi square test). This screening study in patients with chronic HBV or HCV infection demonstrates (1) that the yield of asymptomatic hepatocellular cancer on initial screening is 7.9% and (2) that patients with severe chronic active hepatitis, cirrhosis, or both are at extremely high risk to develop hepatocellular cancer (25%). On the basis of these results and the finding of a significant number of small; treatable hepatocellular cancers (61.1%), the authors recommend hepatocellular cancer screening every 3 months for the subset of high-risk patients.Annals of Surgery 09/1995; 222(3):375-80; discussion 380-3. · 6.33 Impact Factor
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ABSTRACT: Contrasting data have so far been reported on the utility and efficacy of screening patients with cirrhosis for early detection of hepatocellular carcinoma (HCC). The goal of this study was to evaluate the efficacy of a regular ultrasonographic and laboratory follow-up for the early detection of small HCC, and to identify parameters correlated with a higher risk of developing HCC. One hundred and sixty-four consecutive patients with liver cirrhosis living in Emilia Romagna, Italy, were enrolled in the period 1989-1991. All patients underwent clinical, biochemical, and ultrasonographic evaluations at entry and at 3- and 6-month intervals during follow-up. By April 1995, 34 patients had developed HCC. In 76% of the patients, ultrasonography identified HCC when it was still single and small (< 4 cm). At discriminant, logistic regression and univariate analyses, sex and the entry concentration of alkaline phosphatase, alpha-fetoprotein, gamma-glutamyl transpeptidase, and albumin were associated with a higher risk of developing HCC, whereas at multivariate analysis (Cox's model), only sex and the entry concentration of alkaline phosphatase, albumin, and alpha-fetoprotein were independently and significantly related to the appearance of HCC. A regular ultrasonographic follow-up, timed at 3- to 6-month intervals according to the risk of HCC development in patients with cirrhosis, allows the detection of liver carcinoma at an early stage in a high proportion of patients, possibly improving the prognosis of the disease.Cancer 09/1996; 78(5):977-85. · 5.20 Impact Factor