SECAUCUS, N.J., July 8, 2020 /PRNewswire/ -- A Health
Trends™ study from researchers at Quest Diagnostics (NYSE: DGX) and
the University of Pittsburgh Medical
Center (UPMC) provides new evidence that the HPV screening test is
significantly less likely to detect cervical cancer and precancer
than cotesting, a method which combines HPV and Pap (Papanicolaou
test by liquid based cytology) testing using the same specimen.
The study is significant because it is the largest to date to
assess the performance of guideline-recommended cervical cancer
screening methods in a diverse population of American women in
real-world care settings. It reveals stark differences in the
performance of the various recommended methods in detecting cancer
and precancers in women 30 years of age and older.
Published online today in the American Journal of Clinical
Pathology, the peer-reviewed study assesses sensitivity rates
of HPV alone, Pap alone and cotesting (HPV and Pap testing
together) in detecting cancer and precancer of the cervix in nearly
19 million de-identified cotest results performed by Quest
Diagnostics on behalf of 13.6 million women in the United States from 2010 to 2018. Of these
cases, 1,259 were diagnosed with cervical cancer – twice the number
of diagnosed cancer cases as the next largest
study.v
"This Health Trends analysis of a notably large and diverse
population firmly validates the critical role of cotesting as a
cancer and precancer screening method for women 30 and older," said
R. Marshall Austin, MD, PhD,
Emeritus Professor of Pathology, University of
Pittsburgh Medical Center (UPMC). "It should put to rest any
notion that HPV alone achieves the same bar for quality cancer
screening."
HPV testing identifies the genetic material of the human
papillomavirus virus, which can cause cervical cancer, while Pap
identifies cellular changes on the cervix that may be or become
cancer. The United States Preventive Services Task Force (USPSTF)
recommends screening in women 30-65 years of age every three years
with Pap, every five years with cotesting or every five years with
primary HPV testing.
Among the key findings:
- HPV and Pap testing alone fails to detect twice as many
women who develop cervical cancer as cotesting. Of 1,615
cotests taken at any time prior to a cancer diagnosis, 86.9 percent
were positive by cotesting, a non-detection rate (also known as
false negative) of about 13.1 percent. By comparison, Pap and HPV
testing alone had non-detection rates nearly twice as high: Pap at
26.4 percent and HPV at 28.4 percent.
- Cotesting detected significantly more women who developed
biopsy-confirmed adenocarcinomas, a typically aggressive form
of cervical cancer, identifying 82.3 percent of this cancer
compared to only 61.2 percent by HPV and 59.7 percent by Pap.
- HPV testing fails to identify one in five women who develop
cancer when performed within a year of cancer
diagnosis. Among women screened within one year of a
cancer diagnosis, the non-detection rate for HPV testing alone was
22.5 percent, nearly 1.5 times higher than Pap (14.9%) and four
times higher than cotesting (5.9%).
- Cotesting detected more women who developed biopsy-confirmed
precancers than HPV or Pap alone, identifying 95.6 percent of
these precancers, compared to 92.6 percent by HPV and 77.9 percent
by Pap.
According to a report published in January 2020 by the American Cancer Society,
cervical cancer is the second leading cause of cancer death
nationally in women 20-39 years of age, causing 10 premature
deaths per week in this age group.i
"While widespread screening has helped cut cervical cancer
mortality by three fourths in the past 80 yearsii, this
disease is still far too common," said co-author Harvey W. Kaufman, M.D., Senior Medical Director
and Director, Health Trends Research Program, Quest Diagnostics.
"Because most cervical cancers develop in the absence of regular
screening, ensuring women have access to the most reliable
screening method, cotesting, when they are screened is an essential
step in lowering mortality from this disease."
Health Trends study builds on prior research
The new findings confirm previous Quest Diagnostics research
published in Cancer Cytopathology in 2015, a journal of the
American Cancer Society, which found HPV-only cervical screening
would not have detected approximately 19 percent of 526 women who
developed confirmed cervical cancer. An analysis of data from
Magee-Women's Hospital (MWH) of the University
of Pittsburgh Medical Center (UPMC) reported a higher
percent of positive Pap than HPV tests among 109 cotesting results
within 12 months from cancer diagnosis, similar to the present
Quest Diagnostics Health Trends study. iii
By comparison, analysis of a regional dataset from Kaiser
Permanente Northern California (KPNC) also found that cotesting
outperformed other methods, but the authors of that study concluded
that "the contribution of cytology to screening is shown to be very
small."iv The KPNC data were also
limited in its ability to identify cytological abnormalities
associated with confirmed adenocarcinomas, an aggressive cancer, as
compared to the Quest and MWH data.v
"It is important to reconcile the similar conclusions of Quest
Diagnostics and Magee-Women's Hospital with the different findings
of Kaiser Permanente in Northern
California," said Lee H. Hilborne, MD, Professor
of Pathology and Laboratory Medicine at UCLA, Senior Medical Director, Quest
Diagnostics. "KPNC has an exemplary care model, but this very
strength may limit the usefulness of KPNC data for drawing
conclusions about the real-world care experience of most American
women who receive care in less integrated practice settings."
"For women who may otherwise not be screened at all, there is no
question that cytology or HPV primary are useful screening
technologies," said Damian P. Alagia,
III, MD, Senior Medical Director of Woman's Health for Quest
Diagnostics. "Yet, that should not obscure the fact that
cotesting is fundamentally the better screening option for women
and is widely available in the U.S."
Study Strengths and Limitations
The strengths of the
study include the large, longitudinal, nationally representative
sample size and a study population believed to be reflective of
adult women in the United States.
The study period covers nine years (2010-2018). The study was
limited only to women who sought medical care and were referred to
laboratory services at Quest Diagnostics. The Quest Diagnostics
Health Trends study was deemed exempt by the Western Institutional
Review Board.
About Health Trends™
Quest Diagnostics Health Trends™
is a series of scientific reports that provide insights into health
topics, based on analysis of objective clinical laboratory data, to
empower better patient care, population health management and
public health policy. The reports are based on the Quest
Diagnostics database of more than 50 billion de-identified
laboratory test results, believed to be the largest of its kind in
healthcare. Health Trends has yielded novel insights to aid the
management of allergies and asthma, prescription drug monitoring,
diabetes, Lyme disease, heart disease, influenza and workplace
wellness. Quest Diagnostics also produces the Drug Testing
Index (DTI)™, a series of reports on national workplace drug
positivity trends based on the company's employer workplace drug
testing data. www.QuestDiagnostics.com/HealthTrends
About Quest Diagnostics
Quest Diagnostics
empowers people to take action to improve health outcomes. Derived
from the world's largest database of clinical lab results, our
diagnostic insights reveal new avenues to identify and treat
disease, inspire healthy behaviors and improve health care
management. Quest annually serves one in three adult Americans and
half the physicians and hospitals in the United States, and our
47,000 employees understand that, in the right hands and with the
right context, our diagnostic insights can inspire actions that
transform lives. www.QuestDiagnostics.com
i Siegel, R.L., Miller, K.D. and
Jemal, A. (2020), Cancer statistics, 2020. CA A Cancer J Clin, 70:
7-30. doi:10.3322/caac.21590
|
ii Cervical cancer statistics.
Cancer Research. October 2014. "Cervical cancer deaths have
decreased by 74% in the past fifty year). Further: Routine
Pat testing with HPV can reduce cervical cancer incidence by up to
80%. Antilla AM, et al. Annals of Oncology
2010;21(3):448-58
|
iii Austin
RM, Onisko A, Zhao C. Enhanced detection of cervical cancer and
precancer through use of imaged liquid-based cytology in routine
cytology and HPV cotesting. Am J Clin Pathol 2018;
150:385-392.
|
iv Schiffman M, Kinney WK, Cheung LC,
et al. Relative performance of HPV and cytology components of
cotesting in cervical screening. J Natl Cancer Inst
2018;110:501-508.
|
v Adegoke
O, Kulasingam S, Virnig B. Cervical cancer trends in the United
States: a 35-year population-based analysis. J Woman's
Health. 2012;21(10):1031-1037.
|
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