A 20-year follow-up study has revealed a dramatic drop in liver cancer cases among six- to 19-year-olds who were vaccinated for hepatitis B (HBV) at birth. In July 1984, a universal vaccination programme was initiated among newborn children in Taiwan to prevent HBV infection, which can predispose to the development of hepatocellular carcinoma (HCC).
HCC is responsible for approximately 90 per cent of the primary malignant liver tumours in adults. It is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases are diagnosed worldwide each year (>400,000 in China, South Korea, Japan and Taiwan, 54,000 in the EU and 15,000 in the US) and the incidence is increasing. In 2002, approximately 600,000 people died of HCC, including approximately 370,000 in China, South Korea and Japan, 57,000 in the EU and 13,000 in the US.
For the study, which was published in the 16th September online edition of the Journal of the National Cancer Institute (10.1093/jnci/djp288), scientists from the National Taiwan University Department of Pediatrics collected data on 1,958 patients with HCC who were aged six to 29 years at diagnosis in Taiwan between 1983 and 2004 from two national HCC registries. Age- and sex-specific incidence among vaccinated and unvaccinated birth cohorts were analysed by using Poisson regression models. All statistical tests were two-sided. Records of 64 HCC patients and 5,524,435 HBV vaccinees who were born after the initiation of the vaccination programme were compared for HBV immunisation characteristics during infancy and prenatal maternal HBV surface antigen (HBsAg) and e antigen (HBeAg) serostatus.
Results showed that HCC incidence was statistically significantly lower among children aged six to 19 years in the vaccinated cohort compared with the unvaccinated birth cohorts (64 HCCs among vaccinees in 37,709,304 person-years vs 444 cancers in unvaccinated subjects in 78,496,406 person-years, showing an age- and sex-adjusted relative risk of 0.31, p<0.001, for persons vaccinated at birth).
The risk of developing HCC for vaccinated cohorts was statistically significantly associated with: incomplete HBV vaccination (for those who received fewer than three doses of HBV vaccine, odds ratio [OR]=4.32, 95% CI, 2.34 to 7.91); prenatal maternal HBsAg seropositivity (OR=29.50, 95% CI, 13.98 to 62.60); and prenatal maternal HBeAg seropositivity (with administration of HBV immunoglobulin at birth, OR=5.13, 95% CI, 2.24 to 11.71; and without it, OR=9.43, 95% CI, 3.54 to 25.11).
These data suggest that the effectiveness of the universal HBV immunisation programme to prevent HCC has extended beyond childhood and into young adulthood over the past two decades. With regard to the National Institute for Health and Clinical Excellence (NICE) recently refusing Bayer HealthCare/Onyx Pharmaceuticals' Nexavar (sorafenib) for the treatment of patients in England and Wales with HCC, despite being the only systemic treatment option that could potentially extend the survival of patients with the disease, it seems that currently, prevention is better than the cure.
Alice Rossiter
Cancer Drug News Editor
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