A new study led by Columbia University Medical Center researchers
demonstrates the safety and efficacy of two low-tech diagnostic tools to
significantly reduce the prevalence of cervical cancer precursor lesions.
Cervical cancer is the leading cause of cancer-related death in women in many
developing countries. Designed as rapid screen-and-treat methods that could be
done the same day, the protocols could finally make prevention of cervical
cancer a viable option for all women in any setting around the world.
The two screen-and-treat methods, human papillomavirus (HPV) DNA testing and
visual inspection with acetic acid (VIA), followed by treatment using
cryotherapy for all eligible women with positive test results, were found to
perform as well or better than traditional cytology-based screening (Pap smear)
for identifying high-grade cervical cancer precursor lesions. Cryotherapy -
freezing the cervix - is a relatively low-technology treatment method that has
been shown to be highly efficacious with minimal morbidity. This study was the
first time these methods were tested for efficacy in reducing the prevalence of
cervical cancer precursor lesions.
"These are highly effective, low cost methods to reduce the unnecessary
mortality from cervical cancer around the world - especially in the world's
poorest countries," said Thomas C. Wright Jr., M.D., principal investigator
of the study and professor of pathology, Columbia University College of
Physicians & Surgeons. "We found that conducting HPV DNA or VIA
protocols in South Africa were not only much more cost-effective than
traditional cytology-based approaches, but were similar in overall cost to other
well-accepted health interventions, such as childhood vaccines."
Published in the Nov. 2, 2005 issue of the Journal of the American Medical
Association, the randomized clinical trial included 6,555 nonpregnant women,
aged 35 to 65 years, between June 2000 and December 2002 at three ambulatory
women's health clinics in Khayelitsha, South Africa. All women were screened
using HPV DNA and VIA testing. Women were subsequently randomized to one of
three groups: cryotherapy if the woman had a positive HPV DNA test cryotherapy
if the woman had a positive VIA test or to a delayed evaluation group.
The women returned after six and 12 months for follow-up exams. Both the HPV DNA
and VIA testing followed by cryotherapy reduced the prevalence of cervical
cancer precursor lesions, or CIN 2+. After six months, a 77 percent lower
prevalence of CIN 2+ was found among the HPV group compared with the delayed
evaluation group and a 37 percent lower prevalence among the VIA group compared
with the delayed evaluation group.
"This novel approach to cervical cancer prevention is highly acceptable to
the women in the community," said Lynette Denny, M.D., MPH of the
University of Cape Town in South Africa who directed the clinical activities in
Cape Town. "Ninety-nine percent of participants said they would recommend
this type of screening program to friends and family."
"The next step is to conduct large-scale public health intervention
projects to better define the operational needs and challenges of these
programs," said Dr. Wright.
Each year nearly half a million cases and nearly a quarter million deaths occur
from cervical cancer, of which 80 percent occur in less-developed countries that
have access to less than 5 percent of global cancer treatment resources. The
lifetime risk of a woman developing cervical cancer in a low-resource setting is
approximately 2 percent to 4 percent
Health experts have long been frustrated by the high incidence and mortality
rates of cervical cancer - a common and easily preventable cancer in women - in
developing areas. The cytology-based screening programs, which have
significantly reduced the incidence of cervical cancer in the United States and
Europe and other developed parts of the world, have not been feasible for many
low-resource settings because of the complex health infrastructure they require.
Low-resource settings are not able to provide the advanced and lengthy training
needed for cytology laboratories, used to examine Pap smears nor are they set
up for the extensive evaluation used for women with abnormal cytological
results, which typically involves a colposcopy, where a doctor uses a specially
designed microscope to look at the surface of the cervix.
The study, intended to combat these financial and systematic hurdles, was
approved by the institutional review boards of Columbia University Medical
Center and the University of Cape Town (Cape Town, South Africa).
The international group included researchers from Columbia University Medical
Center: Dr. Wright and Louise Kuhn, Ph.D. of the Gertrude H. Sergievsky Center
at Columbia's College of Physicians & Surgeons and the Department of
Epidemiology at Columbia's Mailman School of Public Health. Researchers from the
University of Cape Town included Lynette Denny, M.D., Ph.D. and Michelle De
Souza, M.D., both in the Department of Obstetrics and Gynaecology. The team also
included Amy E. Pollack, M.D., MPH from EngenderHealth in New York, NY and
William Dupree, M.D. from HealthNetwork Laboratory in Allentown, Pa.
Columbia University Medical Center provides international leadership in
pre-clinical and clinical research, in medical and health sciences education,
and in patient care. The medical center trains future leaders in health care and
includes the dedicated work of many physicians, scientists, nurses, dentists,
and public health professionals at the College of Physicians & Surgeons, the
School of Dental & Oral Surgery, the School of Nursing, the Mailman School
of Public Health, the biomedical departments of the Graduate School of Arts and
Sciences, and allied research centers and institutions. Columbia University
Medical Center researchers are leading the discovery of novel therapies and
advances to address a wide range of health conditions. http://www.cumc.columbia.edu
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