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


METHODS
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.


CONCLUSIONS
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.
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of California, Irvine, Medical Center, Orange, CA.
Robert E
RE
Bristow
Melissa
M
Hodeib
Alan
A
Smith
Daniel W
DW
Chan
Zhen
Z
Zhang
Eric T
ET
Fung
Krishnansu S
KS
Tewari
Donald G
DG
Munroe
Frederick R
FR
Ueland
D000291:Adnexal Diseases / Q000175:diagnosis* / Q000601:surgery; D018394:CA-125 Antigen / Q000097:blood*; D004701:Endocrine Gland Neoplasms / Q000175:diagnosis*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012017:Referral and Consultation / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000379:methods*; D012680:Sensitivity and Specificity
D018394:CA-125 Antigen
adnexal mass; referral patterns