May 19, 2011 — Using a new multivariate index assay instead of CA 125 may help identify more ovarian cancers before surgery, according to results from a large multicenter study that evaluated women with pelvic masses, published online May 6 in Obstetrics & Gynecology.
The researchers said use of the new assay (OVA1, Vermillion, Inc) in place of CA 125 improved the sensitivity and negative predictive value of the established guidelines of the American College of Obstetrics and Gynecology (ACOG), and that the test exhibited decreased specificity and positive predictive value.
The assay is the first one approved by the US Food and Drug Administration aimed at helping clinicians sort out, before surgery, which women with pelvic masses are likely to have cancer.
"There have been a number publications and guidelines recommending that women with ovarian cancer be under the care of a gynecologic oncologist," write Rachel Miller, MD, assistant professor of gynecologic oncology at the University of Kentucky, Lexington, and colleagues. Even so, only about a third of women who have surgery for malignant ovarian tumors are referred to specialists for primary surgery, the authors say.
Current ACOG guidelines recommend that healthcare providers use CA 125, in conjunction with other tests and clinical factors, to preoperatively evaluate patients with pelvic masses.
Following the guidelines can help identify advanced ovarian cancer, the authors write; however, they add, "The high sensitivity in premenopausal women and early stage cancers is where CA 125 and the College guidelines have underperformed."
Dr. Miller and colleagues evaluated the performance of the ACOG guidelines, using the CA 125 test compared with the multivariate assay, in 516 women who had been enrolled at 27 primary care and specialty sites throughout the United States. The women were of varying age and ethnicity, and all had presented with pelvic masses and been scheduled for surgery.
The authors say that when the multivariate assay was used in conjunction with the guidelines, 94% of malignancies, in women of all ages, were accurately identified compared with 77% of malignancies correctly identified when the CA 125 test was used.
Improvement in sensitivity was most notable for premenopausal women, with the new test accurately identifying 91% of women with ovarian cancer compared with 58% identified when CA 125 was used.
The researchers note, however, that the new test was about twice as likely as CA 125 to generate false positive results.
Responding to that finding, the company said in a press release, "As OVA1 is only indicated for women for whom surgery is already planned, a higher rate of false positives would increase the possibility that a woman's surgery is performed by a gynecologic oncologist rather than a gynecologist or other non-specialist."
This study comes on the heels of an updated committee opinion on the role of obstetricians-gynecologists in the early detection of ovarian cancer, published in the March issue of Obstetrics & Gynecology. That opinion updated the original opinion, which was published nearly a decade ago.
The updated opinion noted that the new test "appears to improve the predictability of ovarian cancer in women with pelvic masses," adding that although the test is not intended to be used as a screening tool, "it may be useful for evaluating women with a pelvic mass."
Still, the researchers said, more study will be needed to find out how the availability of the new test affects referral of patients to gynecologic oncologists.
Intriguing Results, But It Is Unclear How They Will Affect Practice
A spokesperson for ACOG said that the college has no immediate plans to change its recommendations based on the findings of the study. The guidelines are reviewed regularly, usually on an 18- to 24-month cycle. Even if interim changes to the guidelines were to be considered, the spokesperson said, it is not ACOG policy to discuss such changes ahead of time.
Cara Tenenbaum, vice president of policy and external affairs at the Ovarian Cancer National Alliance, commented, "The good news from this study is that the improved sensitivity of the multivariate assay test could lead to more accurate diagnosis for women with ovarian cancer, compared to current protocols." In contrast, she said, the higher rates of false negatives seen with the test could lead to less-optimal treatment for some women, who would opt for surgery with a gynecologist, rather than a gynecologic oncologist.
"One lingering question is: How will this translate into clinical practice?" Ms. Tenenbaum said. "This study was done on women who had a known pelvic mass, but many women are diagnosed with ovarian cancer based on other symptoms. The results are intriguing, but it's not clear how they will affect doctors' day-to-day practice."
The study was funded by Vermillion, Inc, Austin, Texas. Dr. Miller has disclosed no relevant financial relationships. Several of the other authors have financial relationships with Vermillion, including one who serves on the speaker's bureau and receives honoraria, another who is an independent statistician for Vermillion, and a third who is an employee of the Johns Hopkins Center for Biomarker Discovery, which has a sponsored research grant from Vermillion, and who is therefore entitled to royalty payment from Vermillion.
Obstet Gynecol. Published online May 6, 2011. Abstract
The researchers said use of the new assay (OVA1, Vermillion, Inc) in place of CA 125 improved the sensitivity and negative predictive value of the established guidelines of the American College of Obstetrics and Gynecology (ACOG), and that the test exhibited decreased specificity and positive predictive value.
The assay is the first one approved by the US Food and Drug Administration aimed at helping clinicians sort out, before surgery, which women with pelvic masses are likely to have cancer.
"There have been a number publications and guidelines recommending that women with ovarian cancer be under the care of a gynecologic oncologist," write Rachel Miller, MD, assistant professor of gynecologic oncology at the University of Kentucky, Lexington, and colleagues. Even so, only about a third of women who have surgery for malignant ovarian tumors are referred to specialists for primary surgery, the authors say.
Current ACOG guidelines recommend that healthcare providers use CA 125, in conjunction with other tests and clinical factors, to preoperatively evaluate patients with pelvic masses.
Following the guidelines can help identify advanced ovarian cancer, the authors write; however, they add, "The high sensitivity in premenopausal women and early stage cancers is where CA 125 and the College guidelines have underperformed."
Dr. Miller and colleagues evaluated the performance of the ACOG guidelines, using the CA 125 test compared with the multivariate assay, in 516 women who had been enrolled at 27 primary care and specialty sites throughout the United States. The women were of varying age and ethnicity, and all had presented with pelvic masses and been scheduled for surgery.
The authors say that when the multivariate assay was used in conjunction with the guidelines, 94% of malignancies, in women of all ages, were accurately identified compared with 77% of malignancies correctly identified when the CA 125 test was used.
Improvement in sensitivity was most notable for premenopausal women, with the new test accurately identifying 91% of women with ovarian cancer compared with 58% identified when CA 125 was used.
The researchers note, however, that the new test was about twice as likely as CA 125 to generate false positive results.
Responding to that finding, the company said in a press release, "As OVA1 is only indicated for women for whom surgery is already planned, a higher rate of false positives would increase the possibility that a woman's surgery is performed by a gynecologic oncologist rather than a gynecologist or other non-specialist."
This study comes on the heels of an updated committee opinion on the role of obstetricians-gynecologists in the early detection of ovarian cancer, published in the March issue of Obstetrics & Gynecology. That opinion updated the original opinion, which was published nearly a decade ago.
The updated opinion noted that the new test "appears to improve the predictability of ovarian cancer in women with pelvic masses," adding that although the test is not intended to be used as a screening tool, "it may be useful for evaluating women with a pelvic mass."
Still, the researchers said, more study will be needed to find out how the availability of the new test affects referral of patients to gynecologic oncologists.
Intriguing Results, But It Is Unclear How They Will Affect Practice
A spokesperson for ACOG said that the college has no immediate plans to change its recommendations based on the findings of the study. The guidelines are reviewed regularly, usually on an 18- to 24-month cycle. Even if interim changes to the guidelines were to be considered, the spokesperson said, it is not ACOG policy to discuss such changes ahead of time.
Cara Tenenbaum, vice president of policy and external affairs at the Ovarian Cancer National Alliance, commented, "The good news from this study is that the improved sensitivity of the multivariate assay test could lead to more accurate diagnosis for women with ovarian cancer, compared to current protocols." In contrast, she said, the higher rates of false negatives seen with the test could lead to less-optimal treatment for some women, who would opt for surgery with a gynecologist, rather than a gynecologic oncologist.
"One lingering question is: How will this translate into clinical practice?" Ms. Tenenbaum said. "This study was done on women who had a known pelvic mass, but many women are diagnosed with ovarian cancer based on other symptoms. The results are intriguing, but it's not clear how they will affect doctors' day-to-day practice."
The study was funded by Vermillion, Inc, Austin, Texas. Dr. Miller has disclosed no relevant financial relationships. Several of the other authors have financial relationships with Vermillion, including one who serves on the speaker's bureau and receives honoraria, another who is an independent statistician for Vermillion, and a third who is an employee of the Johns Hopkins Center for Biomarker Discovery, which has a sponsored research grant from Vermillion, and who is therefore entitled to royalty payment from Vermillion.
Obstet Gynecol. Published online May 6, 2011. Abstract
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