Impact of a multivariate index assay on referral patterns for surgical management of an adnexal mass

Robert E. Bristow, Melissa Hodeib, Alan Smith, Daniel W. Chan, Zhen Zhang, Eric T. Fung, Krishnansu S. Tewari, Donald G. Munroe, Frederick R. Ueland

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Objective To determine the impact on referral patterns of using a Multivariate Index Assay, CA125, modified-American College of Obstetricians and Gynecologists referral guidelines, and clinical assessment among patients undergoing surgery for an adnexal mass after initial evaluation by nongynecologic oncologists. Study Design Overall, 770 patients were enrolled by nongynecologic oncologists from 2 related, multiinstitutional, prospective trials and analyzed retrospectively. All patients had preoperative imaging and biomarker analysis. The subset of patients enrolled by nongynecologic oncologists was analyzed to determine the projected referral patterns and sensitivity for malignancy based on multivariate index assay (MIA), CA125, modified-American College of Obstetricians and Gynecologists (ACOG) guidelines, and clinical assessment compared with actual practice. Results The prevalence of malignancy was 21.3% (n = 164). In clinical practice, 462/770 patients (60.0%) were referred to a gynecologic oncologist for surgery. Triage based on CA125 predicted referral of 157/770 patients (20.4%) with sensitivity of 68.3% (95% confidence interval [CI], 60.8-74.9). Triage based on modified-ACOG guidelines would have resulted in referral of 256/770 patients (33.2%) with a sensitivity of 79.3% (95% CI, 72.4-84.8). Clinical assessment predicted referral of 184/763 patients (24.1%) with a sensitivity of 73.2% (95% CI, 65.9-79.4). Risk stratification using multivariate index assay would have resulted in referral of 429/770 (55.7%) patients, with sensitivity of 90.2% (95% CI, 84.7-93.9). MIA demonstrated statistically significant higher sensitivity (P <.0001) and lower specificity (P <.0001) for detecting malignancy compared with clinical assessment, CA125, and modified-ACOG guidelines. Conclusion In this study population, use of MIA as a risk stratification test was associated with referral patterns by nongynecologic oncologists comparable to actual clinical practice and higher sensitivity for malignancy than other adnexal mass triage algorithms.

Original languageEnglish
Pages (from-to)581.e1-581.e8
JournalAmerican Journal of Obstetrics and Gynecology
Volume209
Issue number6
DOIs
StatePublished - Dec 2013

Bibliographical note

Funding Information:
R.E.B., K.S.T., and F.R.U. are or have been members of the speakers bureau of Vermillion, Inc. R.E.B. was principal investigator for an OVA1 trial and was supported in part by the Queen of Hearts Foundation, which had no role in the design, analysis, or writing of this work. He has not received honoraria from Vermillion, Inc. A.S. is a consultant to Vermillion, Inc. D.W.C. serves on the Advisory Board at Vermillion, Inc. Z.Z. is coinventor of patents associated with the OVA1 product and is entitled to royalty payments from the sale of the OVA1 test through a license agreement between Vermillion, Inc., and Johns Hopkins University. His work on OVA1 has been funded through sponsored research agreements between Vermillion Inc. and Johns Hopkins University. E.T.F. was an employee of Vermillion when the work was conducted. K.S.T. has received honoraria from Vermillion, Inc. D.G.M. is an employee of Vermillion Inc., which funded and sponsored this study. E.T.F. owns stock in Vermillion. F.R.U. was the principal investigator for an OVA1 trial. He has received honoraria from Vermillion Inc. M.H. reports no conflict of interest.

Funding Information:
This study was funded by Vermillion Inc. , Austin, TX.

Keywords

  • adnexal mass
  • referral patterns

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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