Nov. 5, 2009 -- A new vaccine may hold promise for millions of women who have the human papillomavirus and its accompanying often-painful lesions of precancerous tissue.
In a small study of 20 women, researchers found the HPV vaccine soothed symptoms and shrank or completely removed lesions in 79 percent of patients one year after treatment. Nearly half of the women showed no sign of the disease two years after the shots.
The study, published in the New England Journal of Medicine Wednesday, is one of several research attempts to curtail the HPV infection after it has already attacked the cervix or vulva.
For women who have undergone the existing treatment to remove the lesions -- by scalpel, by lasers, by freezing or removing lesions with what's known as a loop electrosurgical excision procedure -- the idea of a therapeutic vaccine is all too welcome.
"The stress was maddening, recovering from the surgery was worse than I ever could have imagined -- horrendous," Kathy Howe said of her 2006 diagnosis of precancerous lesions on her cervix caused by HPV.
Howe wrote about her cervical cancer ordeal on her blog, Kazoofus.com.
"It was a very long process, over a year and a half of tests, questions and not many clear answers as a result of all the tests," she said.
The U.S. Centers for Disease Control and Prevention estimates that half of all men and women contract genital HPV infections during their lifetimes and about 10 percent of women with aggressive strains of HPV will develop long-term infections that put them at risk for cervical cancer.
In less than two years, Howe had four pap smears, two diagnostic procedures called coloscopies and two loop procedures, which entailed transmitting an electrical current through a wire loop to remove the precancerous tissues. By October 2007, doctors decided to remove her cervix.
That kind of trouble and cost is exactly what researchers are trying to avoid.
HPV Can Turn into Precancerous Lesions
"We hoped for this good response and, in fact, expected it," said the co-author of the paper, Dr. Gemma Kenter of the Leiden University Medical Center in the Netherlands.
Kenter had done previous research in women's immune response to HPV infections.
The vaccine used in Kenter's research is different from preventive shots on the market, such as Gardasil, so while the research is promising, he and his colleagues still recommend preventing the disease rather than treating it later.
Because the vaccine functions differently, Kenter's colleague on the study points out that their research shows promise for treating a variety of diseases from HPV, even in the throat.
"Yes, I feel that there is hope for the millions of people who are already infected with HPV but it should be needless to say that this is just a first trial and a real efficacy trial still has to be done," said Sjoerd H. van der Burg, a co-author on the paper and a researcher in the Clinical Oncology Department of Leiden University.
Hope for HPV Treatment but a Distant One
It can take a decade or more for success found in such a small study to translate into a vaccine on the market, according to Dr. Kevin Ault, associate professor of gynecology and obstetrics at the Emory University School of Medicine in Atlanta.
Ault said the study was "very well done" but cautioned that with such a small study, it's difficult to know the potential side effects of the vaccine.
Still, doctors are eager to improve the existing line of treatment for the precancerous lesions called dysplasias.
"We usually operate on someone and there's a 50 percent chance that they'll have to come back to operate again," Ault said. "Therapeutic vaccines are something we're always interested in and there are a lot of things in the pipeline that are similar to this."
If therapeutic vaccine comes to market, doctors warn, it may never replace the need for surgical procedures on the cervix, as in the case of the study subjects, or the vulva.
Therapeutic Vaccine May Never Replace Surgical Procedures
"The most serious risk of vaccine treatment would be the delay in the diagnosis or treatment of an early, occult vulvar cancer," said Dr. Brent DuBeshter, director of gynecologic oncology at the University of Rochester Medical Center in New York.
Without a surgical excision, DuBeshter noted, it is not always possible to distinguish vulvar dysplasia from an early cancer.
"It should be noted that one of the study patients did develop an invasive cancer," said DuBeshter, who predicted the vaccine's "greatest role may be to help prevent recurrences, which are all too common."
Sue Turnbull, a clinical nurse who counsels nearly all the women who receive an abnormal pap smear at the West Virginia University Student Health Center in Morgantown, has seen the 10 percent of women infected with aggressive HPV strains come back repeatedly for tests and procedures.
She said the greater the number of operations on the cervix, the greater the likelihood that woman will have problems with a weakened, so-called compromised cervix later on. Women with the condition often require bed rest during pregnancy in order to prevent a premature birth.
"Really, there is no way right now to cure it once someone is exposed to HPV, but you can do things to hopefully keep it dormant by boosting your immune system," Turnbull said.
Women younger than 21 who are diagnosed with a low-grade abnormal pap smear are scheduled to be screened again in either six months or a year and told to boost their immune systems with more sleep, vitamins and a smoke-free environment, Turnbull said.
In 90 percent of these cases, she said, the immune system takes care of the lesions. "Unfortunately, I don't have a crystal ball to say you definitely will fall into this 90 percentile," Turnbull said.
Amanda, who wished to remain anonymous for privacy reasons, has experienced the trouble with screening and recurrences of the lesions. Now living in Houston, Amanda experienced a tortuous time on the East Coast after she went two years without a pap smear because of lack of health insurance.
"When I went the first time, they told me my pap came back abnormal," she said. "I went back a second time and it was normal. By 1999 [two years later], I finally had health insurance again so I went to get a pap and it was abnormal, cervical dysplasia level three, which is the one right before you have cancer."
Women Call HPV Lesion Treatment 'Invasive'
Amanda went through two loop procedures to get rid of the lesions, the first of which was extremely painful.
"They were going to go in and scrape out the precancerous cells with some sort of wire thing," Amanda said. "She [the doctor] sprayed some sort of numbing stuff on me and it wasn't enough, so I started screaming."
After giving her a sedative and some more anesthetic, Amanda said the doctor continued the procedure. She rode home on a bus doubled over cramping, discharging blood. The pain lasted for weeks.
"I feel it was so invasive as a woman, they tell you it's going to be so easy, but it's still invasive," Amanda said. "I think a lot of women would prefer a less invasive treatment."