Skip to main content
Open access
Research Article
22 May 2023

A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk

Abstract

Aim: This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. Materials & methods: This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. Results: Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. Conclusion: This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.

Supplementary Material

File (supplementary data.docx)

References

1.
Ovarian Cancer Research Fund Alliance. Statistics. http://www.ocrfa.org/members/about-ovarian-cancer/statistics/
2.
Torre LA, Trabert B, DeSantis C et al. Ovarian cancer statistics, 2018. CA Cancer J. Clin. 68(4), 284–296 (2018).
3.
Zhang Z, Bullock RG, Fritsche H. Adnexal mass risk assessment: a multivariate index assay for malignancy risk stratification. Future Oncol. 15(33), 3783–3795 (2019).
4.
Glanc P, Benacerraf B, Bourne T et al. First international consensus report on adnexal masses: management recommendations: international consensus on adnexal masses. J. Ultrasound Med. 36(5), 849–863 (2017).
5.
Surveillance, Epidemiology, and End Results Program (SEER). National Cancer Institute. Cancer stat facts: ovarian cancer. https://seer.cancer.gov/statfacts/html/ovary.html
6.
American College of Obstetricians and Gynecologists. ACOG practice bulletin. Management of adnexal masses. Obstet. Gynecol. 128, 1193–1195 (2016).
7.
Longoria RS, Ueland FR, Zang Z et al. Clinical performance of a multivariate index assay for detecting early-stage ovarian cancer. Am. J. Obstet. Gynecol. 210(1), P78.E1–P78.E9 (2014).
8.
Coleman RL, Herzog TJ, Chan DW et al. Validation of a second-generation multivariate index assay for malignancy risk of adnexal masses. Am. J. Obstet. Gynecol. 215(1), 82.e1–82.e11 (2016).
9.
Brodsky BS, Owens GM, Scotti DJ et al. Economic impact of increased utilization of multivariate assay testing to guide the treatment of ovarian cancer: implications for payers. Am. Health Drug Benefits 10(7), 351–359 (2017).
10.
Bristow RE, Smith A, Zhang Z et al. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol. Oncol. 128(2), 252–259 (2013).
11.
Ueland FR, Desimone CP, Seamon LG et al. Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstet. Gynecol. 117(6), 1289–1297 (2011).
12.
Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. Advances in ovarian cancer therapy. Cancer Chemother. Pharmacol. 81(1), 17–38 (2018).
13.
Springer S, Masica DL, Dal Molin M et al. A multimodality test to guide the management of patients with a pancreatic cyst. Sci. Transl. Med. 11(501), eaav4772 (2019).
14.
Department of Health & Human Services. Food and Drug Administration. https://www.accessdata.fda.gov/cdrh_docs/reviews/k081754.pdf
15.
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins – Gynecology. Practice bulletin no. 174: evaluation and management of adnexal masses. Obstet. Gynecol. 128(5), e210–e226 (2016).
16.
Dearking AC, Aletti GD, McGree ME et al. How relevant are ACOG and SGO guidelines for referral of adnexal mass? Obstet. Gynecol. 110(4), 841–848 (2007).
17.
Shaw R, Lokshin AE, Miller MC, Messerlian-Lambert G, Moore RG. stacking machine learning algorithms for biomarker-based preoperative diagnosis of a pelvic mass. Cancers 14(5), 1291 (2022).
18.
Rothwell, Peter M. Factors that can affect the external validity of randomised controlled trials. PLOS Clin. Trials 1(1), e9 (2006).