Randomized controlled trial of screening for hepatocellular carcinoma

Original Paper

Abstract

Purpose

Screening for hepatocellular carcinoma (HCC) has been conducted for over 20 years, but there is no conclusive evidence that screening may reduce HCC mortality. The aim of this study was to assess the effect of screening on HCC mortality in people at increased risk.

Methods

This study included 18,816 people, aged 35–59 years with hepatitis B virus infection or a history of chronic hepatitis in urban Shanghai, China. Participants were randomly allocated to a screening (9,373) or control (9,443) group. Controls received no screening and continued to use health-care facilities. Screening group participants were invited to have an AFP test and ultrasonography examination every 6 months. Screening was stopped in December 1997; by that time screening group participants had been offered five to ten times. All participants were followed up until December 1998. The primary outcome measure was HCC mortality.

Results

The screened group completed 58.2 percent of the screening offered. When the screening group was compared to the control group, the number of HCC was 86 versus 67; subclinical HCC being 52 (60.5%) versus 0; small HCC 39 (45.3%) versus 0; resection achieved 40 (46.5%) versus 5 (7.5%); 1-, 3,-, and 5-year survival rate 65.9%, 52.6%, 46.4% versus 31.2%, 7.2%, 0, respectively. Thirty-two people died from HCC in the screened group versus 54 in the control group, and the HCC mortality rate was significantly lower in the screened group than in controls, being 83.2/100,000 and 131.5/100,000, respectively, with a mortality rate ratio of 0.63 (95%CI 0.41–0.98).

Conclusions

Our finding indicated that biannual screening reduced HCC mortality by 37%.

Keywords

Hepatocellular carcinoma Screening Randomized controlled trial Mortality 

References

  1. Chen DS, Sheu JC, Sung JL, Lai MY, Lee CS, Su CT (1982) Small hepatocellular carcinoma: a clinicopathological study in thirteen patients. Gastroenterology 83:1109–1119PubMedGoogle Scholar
  2. Chen JG, Lu JH, Zhang BC, Chen QG, Hui ZX, Shen QJ (1997) Study on effect of screening on mortality of primary cancer of liver. Chin J Public Health 16:341–343Google Scholar
  3. Izzo F, Cremona F, Ruffolo F, Palaia R, Parisi V, Curley SA (1998) Outcome of 67 patients with hepatocellular cancer detected during screening of 1125 patients with chronic hepatitis. Ann Surg 227:513–518CrossRefPubMedGoogle Scholar
  4. McMahon BJ, London T (1991) Workshop on screening for hepatocellular carcinoma. J Natl Cancer Inst 83:916–919PubMedGoogle Scholar
  5. McMahon BJ, Bulkow L, Harpster A, Snowball M, Lanier A, Sacco F, Dunaway E, Williams J (2000) Screening for hepatocellular carcinoma in Alaska natives infected with chronic hepatitis B: a 16-year population-based study. Hepatology 32:842–846CrossRefPubMedGoogle Scholar
  6. Mima S, Sekiya C, Kanagawa H, Kohyama H, Gotoh K, Mizuo H (1994) Mass screening for hepatocellular carcinoma: experience in Hokkaido, Japan. J Gastroenterol Hepatol 9:361–365PubMedGoogle Scholar
  7. Parkin DM, Bray F, Ferlay J, Pisani P (2001) Estimating the world cancer burden: Globocan 2000. Int J Cancer 94:153–156Google Scholar
  8. Purves LR (1976) Alpha-fetoprotein and the diagnosis of liver cell cancer. In: Cameron HM, Linsell DA, Warwick GP (eds) Liver cell cancer. Elsevier, Amsterdam, The Netherlands, pp 61–80Google Scholar
  9. Shanghai Coordinating Group for Research on Liver Cancer (1979) Diagnosis and treatment of primary hepatocellular carcinoma in early stage—report of 134 cases. Chin J Med 92:801–806Google Scholar
  10. Sherman M, Pelterkiam KM, Lee C (1995) Screening for hepatocellular carcinoma in chronic carriers of hepatitis B virus: incidence and prevalence of hepatocellular carcinoma in a North American urban population. Hepatology 22:432–438PubMedGoogle Scholar
  11. Tang ZY, Yang BH, Tang CL (1980) Evaluation of population screening for hepatocellular carcinoma. Chin Med J 93:795–799PubMedGoogle Scholar
  12. Tang ZY (1989) Efforts in the past decades to improve the ultimate outcome of primary liver cancer. In: Tang ZY, Wu MC, Xia SS (eds) Primary liver cancer. Springer, Berlin Heidelberg New York, pp 469–481Google Scholar
  13. Tatarinov Y (1964) Detection of embryo-specific-globulin in the blood sera of patients with primary liver tumors. Vopr Med Khim 10:90–91PubMedGoogle Scholar
  14. The Liver Cancer Study Group of Japan (1990) Primary liver cancer in Japan. Clinicopathologic features and results of surgical treatment. Ann Surg 211:277–287PubMedGoogle Scholar
  15. Yang B, Zhang B, Yu Y, Wang W, Shen Y, Zhang A, Xiang Y, Xu Z (1997) Prospective study of early detection for primary liver cancer. J Cancer Res Clin Oncol 123:357–360CrossRefPubMedGoogle Scholar
  16. Yang BH, Tang ZY (1988) HCC detected in mass screening from high risk population. Chin J Digest 8:130–133Google Scholar
  17. Yang BH, Tang ZY (1989) The value of real-time ultrasonography in massive screening for primary liver cancer. Tumor 9:117–118Google Scholar
  18. Yang BH, Liu KD, Tang ZY (1987) Mass survey for hepatocellular carcinoma in high risk population. Tumor 7:82–83Google Scholar
  19. Yu SZ (1995) Primary prevention of hepatocellular carcinoma. J Gastroenterol Hepatol 10:674–682PubMedGoogle Scholar
  20. Zhang B, Yang B (1999) Combined alpha-fetoprotein testing and ultrasonography as a screening test for primary liver cancer. J Med Screen 6:108–110PubMedGoogle Scholar
  21. Zhang BC, Wang MR, Chen JG, Jiang RH, Chen QG, Hui ZG (1994) Analysis of patients with primary liver cancer detected (1) at mass screening and (2) during follow-up period in a high risk population. Chin J Clin Oncol 21:489–491Google Scholar
  22. Zhang B, Yang B, Yu Z (1995) The study of high-risk population for primary liver cancer. Tumor 15:80–82Google Scholar
  23. Zhu YR, Lu XB (1983) Clinical implication of AFP serosurvey. Chin J Oncol 5:38–40Google Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Liver Cancer Institute of Fudan UniversityZhongshan Hospital200032China

Personalised recommendations