New Test May Help in Detecting Ovarian Cancer

The U.S. Food and Drug Administration (FDA) today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer.

If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result. The test should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.The new test is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.“Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore (USA).

For more information:

• National Cancer Institute
• The Johns Hopkins University

Also read these abstracts:

• Zhu LR, Zhang WY, Yu L, Zheng YH, Zhang JZ, Liao QP. Serum proteomic features for detection of endometrial cancer. Int J Gynecol Cancer. 2006 May-Jun;16(3):1374-8.
• Lin YW, Lin CY, Lai HC, Chiou JY, Chang CC, Yu MH, Chu TY. Plasma proteomic pattern as biomarkers for ovarian cancer International Gynecol. Cancer 2006,16(Suppl. 1)139-146.
• Moscova M, Marsh DJ, Baxter RC. Protein Chip Discovery of Secreted Proteins Regulated by the Phosphatidylinositol 3-Kinase Pathway in Ovarian Cancer Cell Lines Cancer Res. 2006 Feb 1;66(3):1376-83.
• Bin Ye, Steven Skates, Samuel C Mok, Nora K Horick, et al. Proteomic-based discovery and characterization of glycosylated eosinophil-derived neurotoxin and COOH-terminal osteopontin fragments for ovarian cancer in urine. Clin Cancer Res. Jan 15 2006; 12(2): 432-41.
• Moshkovskii SA, Serebryakova MV, Kuteykin-Teplyakov KB, Tikhonova OV, Goufman EI, et al. Ovarian cancer marker of 11.7 kDa detected by proteomics is a serum amyloid A1 Proteomics Sep.2005;5(14) 3790-7.
• Kozak, K.R., Amneus, M.W., Pusey, S.M., et al. Identification of biomarkers for ovarian cancer using strong anion-exchange ProteinChips: Potential use in diagnosis and prognosis Proceedings of the National Academy of Sciences, 100, 12343-12348, (2003)

Images courtesy American Society of Clinical oncology (ASCO)

No survival benefit with treatment based on rising CA125 blood levels in Recurrent Ovarian Cancer

There appears to be no survival advantage to treating ovarian cancer relapse based on rising CA125 levels, compared with waiting for symptoms. This is the conclusion from a study that was featured during the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), the world’s leading professional organization representing physicians who care for people with cancer.

A team of researchers, lead by Gordon J. Rustin, MD professor of oncology at Mount Vernon Cancer Center, Hertfordshire, United Kingdom, reported that starting treatment immediately for an ovarian cancer relapse based on CA125 protein levels found in the blood does not improve overall survival, compared with delaying treatment until symptoms arise. The findings should allow women to avoid the anxiety and cost associated with frequent blood testing and the toxicity of early treatment.

“Women who’ve completed ovarian cancer treatment often worry about a relapse, and they undergo frequent blood tests for CA125 in the hope of catching it early,” Rustin said.

CA125 often rises several months before women with OC have symptoms or clinical signs of relapse. This study (MRC OV05/EORTC 55955 trials), conducted by the MRC/NCRI and EORTC Gynae Cancer Intergroups, was designed to determine whether there were benefits from early treatment based on a confirmed elevation of CA125 levels versus delaying treatment until clinically indicated.

“We thought that delaying chemotherapy might make overall quality of life worse, due to the symptoms of ovarian cancer, but this was not seen in women on this trial. Since there is no benefit from early chemotherapy, patients may choose to avoid the inconvenience and anxiety associated with frequent retesting for CA125 levels as well as unnecessary early initiation of treatment for relapse,” Rustin explains.

CA125 is a marker of growth for several cancers, including ovarian cancer, and is measured by a blood test. Women who have undergone treatment for ovarian cancer may have their CA125 levels tested as often as every three months for several years after initial treatment.

In this study, investigators compared overall survival between 265 women with ovarian cancer in remission after initial chemotherapy who began second-line chemotherapy after experiencing a rise in CA125, and 264 women with rising CA125 whose treatment was delayed until symptoms of relapse appeared (such as pelvic pain or bloating).

Even though the early treatment group started second-line chemotherapy an average five months before the delayed treatment group, overall survival was the same between both groups: 41 months since completion of first-line chemotherapy.

The researchers added that this trial provides important information that will help women make informed choices about their follow-up and treatment. They can be reassured that treatment can safely be delayed until symptoms develop.

ASCO 2009 abstract:

• G. J. Rustin, M. E. van der Burg, on behalf of MRC and EORTC collaborators. A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). Abstract P1. D2 Plenary Presentation, Sunday, May 31, 2009 1:45 PM EDT, Level 2, Westhal, Plenary Session.

For more information, read these PubMed abstracts:

• Sivanesaratnam V. Third S. S. Ratnam Memorial Lecture 2007. Ovarian cancer: Is there hope for women? J Obstet Gynaecol Res. 2009 Jun;35(3):393-404.
• Gupta D, Lis CG, Vashi PG, Lammersfeld CA. Impact of improved nutritional status on survival in ovarian cancer. Support Care Cancer. 2009 May 31. [Epub ahead of print]
• Turgut O, Tandogan I, Yilmaz MB, Gul I, Gurlek A. CA125 levels among patients with advanced heart failure: An emerging independent predictor for survival. Int. J Cardiol. 2009 May 13. [Epub ahead of print].

Help your patients understand:

• For consumer-oriented information about the studies in this article, please refer your patients to ASCO’s patient website.

Photo and illustration courtesy of the American Society of Clinical Oncology.