New Biomarker Could Improve Detection of Ovarian Cancer

[Guest guest]

New Biomarker Could Improve Detection of Ovarian Cancer

Zosia Chustecka

Medscape Medical News 2007. © 2007 Medscape

December 21, 2007 ­ A new biomarker, serum levels

of HE4, could improve the detection of ovarian

cancer, particularly in the early stages, when

there is a better chance of successful treatment,

say researchers reporting a prospective study

online December 3 in Gynecologic Oncology. A test

for this biomarker (developed by Fujirebio

Diagnostics) is awaiting approval by the FDA.

HE4 was the most effective of the 9 biomarkers

that the researchers evaluated, and was better

than CA125, which is currently the most widely

used serum biomarker for detecting ovarian cancer

and is considered to be the gold standard. Using

HE4 in combination with CA125 improved the results further.

" Our results show that testing women suspected of

ovarian cancer for both CA125 and HE4 could

possibly lead to a screening and diagnostic

tool, " said lead researcher G. , MD,

from Women and Infants Hospital, Brown

University, in Providence, Rhode Island. In an

interview with Medscape Oncology, he explained

that testing for these biomarkers would be

particularly useful in a triage situation where

women present with a pelvic mass because it could

predict who is likely to have ovarian cancer.

These patients could then be steered toward

specialists centers; data show that specialist

surgery and treatment of ovarian cancer leads to

less morbidity and a higher survival rate. In the

future, there is also hope that these biomarkers

could be used for screening populations of

healthy postmenopausal women to detect ovarian

cancer in the early stages, when it is most

treatable, he said. Such studies are currently

being planned in the United States, but 1

screening study with CA125 is already underway in the United Kingdom, he said.

The study conducted by Dr. and colleagues

involved 256 women who presented with an adnexal

mass and were scheduled to undergo surgery. Serum

and urine samples taken preoperatively were then

compared with results from biopsies. Of the 233

patients who were eligible for analysis, 67 were

found to have invasive epithelial ovarian cancers

and 166 had benign ovarian neoplasms. Among the

67 patients found to have ovarian cancer, 13

(19%) were diagnosed with surgical stage 1

disease, 2 (3%) with stage 2 disease, 46 (69%)

with stage 3 disease, and 6 (95%) with stage 4 disease.

Dr. and colleagues investigated 9 different

biomarkers. In addition to HE4 and CA125, they

also tested blood for soluble mesothelin-related

peptide (SMRP), CA72-4, activin A, inhibin,

osteopontin, epidermal growth factor, and serum

Her2. Urinary levels of SMRP and CA125 were also analyzed.

The levels for all these biomarkers (with the

exception of Her2) were significantly different

between patients with cancer and those with

benign masses, indicating their ability to

identify malignant disease. Serum HE4 had the

highest sensitivity (72.9%) for detecting a

malignancy, at the specificity of 95%. When HE4

was combined with CA125, this increased further

to yield a sensitivity of 76.4% and a specificity of 95%.

The combination of both biomarkers added 3.5% to

the sensitivity of HE4 alone, and 33.1% to the

sensitivity of CA125 alone, the researchers

comment. Adding 1 or more biomarkers added only a

small percentage to the sensitivity of combined

HE4 and CA125, and did not increase it

significantly. " Such additions are of limited

incremental value " to the combination of HE4 and CA125, say the researchers.

HE4 also had the highest sensitivity (45.9%, with

a specificity of 95%) for detecting stage 1

disease and differentiating it from benign

masses. CA125 alone is of no clinical value in

this group of patients, the researchers note.

In addition, HE4 had a greater sensitivity for a

given specificity than CA125 for women who were

premenopausal, although the sensitivity of both

biomarkers was similar in postmenopausal women.

" This study demonstrates that the addition of HE4

to CA125 significantly elevates the sensitivity

and specificity over that of CA125 alone, " the researchers conclude.

The study was supported by grants from Ovarian

Cancer SPORE and the National Cancer Institute.

Dr. has disclosed no relevant financial relationships.

Gynecologic Oncology. Published online December 3, 2007.