Vaccine Against HPV-16 and, Possibly, Cervical Cancer

from Journal Watch
Physician-authored summaries and commentary
from the publishers of the New England Journal
of Medicine

Posted 01/21/2003


Summary

Cervical cancer is the second-ranking cause of cancer deaths in women worldwide. Almost all cases of cervical cancer are associated with human papillomavirus (HPV) infection, particularly HPV-16, which is present in nearly 50% of cases.

In an industry-funded study, a U.S. multicenter team randomized 2392 young women to receive 3 doses of an intramuscular vaccine that contained HPV-16 virus-like particles (not live virus) or placebo. Sixty-four percent of the women did not have evidence of HPV-16 infection at study entry: After a median follow-up of 17.4 months, significantly more cases of persistent HPV-16 infection were found in the placebo group than in the vaccine group (3.8 cases/100 woman-years vs. 0 cases). All 9 cases of HPV-16-related cervical intraepithelial neoplasia occurred in the placebo group. Among women who were infected with HPV-16 at study entry, rates of persistent HPV-16 infection were 6.3 and 0.6 cases/100 woman-years in the placebo and vaccine groups, respectively. No serious vaccine-related adverse events were reported, and symptoms that might have indicated adverse reactions were no more common in the vaccine group than in the placebo group.
Comment

The results of this large, well-designed study provide convincing evidence that this new vaccine can protect nearly perfectly against persistent HPV-16 infection and the preneoplastic conditions caused by such infection. This vaccine, or better yet, one that would protect against additional cancer-associated HPVs, might prove to be the most important intervention yet against cervical cancer.

— Anthony L. Komaroff, MD
Source

Koutsky LA et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002 Nov 21; 347:1645-51.

Crum CP. The beginning of the end for cervical cancer? N Engl J Med 2002 Nov 21; 347:1703-5.