Critical Values - January 2009 - (Page 26) Volume 2 • Issue 1 • January 2009 HPV Vaccine to Transform Testing Protocol, Profession Sooner Rather than Later Stoler By Mark H. Stoler, MD, FASCP Q. How will the HPV vaccine affect cervical cancer screening? A. As the prevalence of cervical cancer and its precursors drops because of continued screening and vaccine implementation, the clinically significant disease remaining will be harder to detect. Hence, more sensitive screening tests will be needed. Therefore, the protocol will gradually transition from doing Pap smears first and HPV tests only for triage, to the current situation in which for women older than 30 years Pap and HPV tests are being done together, to the future situation in which HPV will probably be done first and either cytology second or not at all. That’s the road map. However, the rate of that transition will vary with the rate of adoption of HPV testing, the rate of adoption of the vaccine, as well as the clinical trials that show HPV testing is more sensitive and easier to do than cytology. Yet we’re already driving down the road. European pathologists are somewhat ahead, in part because they’ve never really been that satisfied with only cytology. Then again, despite the incredible success of the Pap, neither are U.S. pathologists. When will that process be complete? Considerably more data will be available in the next five years from head-to-head primary screening trials comparing cytology to molecular testing. Such trials have already been conducted in Canada, Scandinavia, Italy, and England. The data all point toward an HPV-first, cytology-second scenario. Such head-to-head trials have not yet been conducted in the United States. Given that such trials have to be large scale and expensive to be definitive, there will be no national guidelines about changing the screening paradigm for three to five years unless data from outside the United States are used. That doesn’t mean, however, that planning for the transition should not begin. First, it’s scientifically better medicine, and second, it takes a long time to plan and implement these transitions. If pathologists don’t plan for it, the system may well fall apart on its own. Q. How quickly do you expect widespread acceptance and adoption of the HPV vaccine? A. There’s a whole psychology of vaccine adoption—early adopters versus those who think early adopters are guinea pigs and who will wait to see what happens—that has to take its natural course. Vaccination for many diseases has been going on for a long time, 60 years, and a great deal is known about how to vaccinate populations. Do I think all cervical cancer will be eliminated in the next 60 years? No. But the reality is that if these vaccines are used, the prevalence of the disease is going to drop to a level where it doesn’t make any sense to screen. While it’s going to take a long time—and I emphasize these are the early times— there will still be some impact on workloads in the near term if women are vaccinated. In addition, and I hope in the not-too-distant future, there will be a vaccine that covers more than 95% of the “bad” HPVs instead of only 70%. If everybody is vaccinated, eventually there will be no clinically meaningful abnormal Paps for anybody to look at. There has to be a plan for that. The medically responsible thing to do is not only plan for it but also promote it and make it happen as soon as possible, because it’s a better overall situation for patients. So what is hampering progress? 26
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