SAN DIEGOAnnual transvaginal ultrasound screening permitted
early detection of most ovarian cancers and improved 5-year survival
from about 50% to 88% in screened patients, John R. van Nagell, MD,
reported at a plenary session of the 31st Annual Meeting of the
Society of Gynecologic Oncologists (SGO).
The goal of this study was to determine the efficacy of annual
transvaginal ultrasound screening as a test for ovarian cancer,
Dr. van Nagell told ONI in an interview. Efficacy was defined
as the ability to decrease the stage of cancer at detection and to
affect case-specific survival. Dr. van Nagell is in the
Department of Obstetrics and Gynecology, University of Kentucky, Lexington.
The investigators performed annual transvaginal ultrasound on 14,469
asymptomatic women from 1987 to 1999. The study included women who
were either age 30 or older with a family history of ovarian cancer,
or age 50 or older. An abnormal sonogram was defined as showing
either an ovarian volume greater than 10 cm³ in postmenopausal
women or greater than 20 cm3 in premenopausal women, or a papillary
or complex tissue projection into a cystic ovarian tumor.
The transvaginal ultrasound procedure requires about 5 minutes to
perform. It is provided at no cost to study patients, but Dr. van
Nagell estimated that it might cost $35 in routine use.
Exactly who should be screened is unclear, but Dr. van Nagell said
that two high-risk groups are candidates: all women over age 50 and
women over age 25 who have a documented family history of ovarian
cancer in a first-degree or second-degree relative.
Sonograms were repeated at 4 to 6 weeks in women who had abnormal
screening sonograms. The investigators did serum CA 125 assays, tumor
morphology indexing, and Doppler flow sonography of women with
persistently abnormal scans, and those women were advised to have
surgical tumor removal.
As a result, 180 patients with persisting transvaginal ultrasound
abnormalities underwent exploratory surgery, which revealed 17
ovarian cancers. Eleven were stage I, three were stage II, and three
were stage III. At the time of the presentation, all patients with
stage I or II ovarian cancer were still alive without recurrence at a
mean follow-up time of 4.6 years (range, 0.82 to 9.6 years). Two of
the three stage III patients have died of disease.
Four patients developed ovarian or primary peritoneal cancers within
12 months after a negative scan. Two of these were stage II, and two
were stage III. Dr. van Nagell said that three of these patients were
alive with no evidence of disease at 0.2 years, 1.7 years, and 5.5
years after diagnosis, and one patient died of disease 0.7 years
In this group of screened women, transvaginal ultrasound had a
sensitivity of 81% and specificity of 98.9%. Positive predictive
value was 9.4%. Negative predictive value was 99.97%.
After 46,113 screening years, there have been three ovarian
cancer deaths in this annually screened population. The survival of
ovarian cancer patients in the study population was 95% at 2 years
and 88.2% at 5 years, he said.
The investigators concluded that annual transvaginal ultrasound
screening is associated with a decrease in stage at detection and a
decrease in case-specific ovarian cancer mortality, but does not
appear to be effective in detecting primary peritoneal cancer.
If annual transvaginal ultrasound screening is done in a center
with experienced people to read the sonograms, I would expect a
significant decrease in mortality from ovarian cancer in the screened
women, Dr. van Nagell said. The implication of our study
is not that we should start doing transvaginal ultrasound in every
office. We have about 50,000 screening-years of data, and we need at
least 100,000 screening-years before it is ready for widespread
Transvaginal ultrasound screening is currently available at the
University of Kentucky and at National Cancer Institute sites
associated with the PLCO (Prostate, Lung, Colon, Ovarian) screening
trial, Dr. van Nagell said.