Highlights
- •Compliance with biomarker blood tests performed every 4 months was high (83.2%).
- •Compliance with standard surveillance ultrasounds and CA 125 was significantly lower (51.9%).
- •Women who did biomarker testing every 4 months had lower stress scores at 12 months than at baseline.
Abstract
Objective
We assessed the feasibility, patient acceptability of and compliance of a new surveillance
strategy for ovarian cancer surveillance in women with BRCA mutations, based on assessments
of serum CA125 and HE4 every 4 months (Risk of Ovarian Cancer Algorithm (ROCA) arm),
compared to Standard of Care (SOC) surveillance with CA125 blood tests and pelvic
ultrasounds every 6 months.
Methods
Women were recruited 6/13/16–9/11/17 from an integrated health care system in California
for this non-randomized prospective cohort study. Women were invited to participate
in a novel serum biomarker surveillance strategy using ROCA or they could opt to be
in the standard of care control arm with ultrasound and CA 125 every 6 months. Outcomes
assessed included compliance, self-reported distress using the Impact of Event Scale
(IES) and cancer anxiety using the Cancer Worry Scale.
Results
There were 159 women in the ROCA arm and 43 in the SOC arm. Overall, compliance was
higher in the ROCA arm (83.2%) than in SOC (51.9%), p < 0.0001. Based on the IES, ROCA arm women reported less feelings about intrusion
and avoidance at 12 months compared to baseline; the difference approached significance
for intrusion (7.6% vs 4.1% severe, p = 0.057) and was statistically significant for avoidance (20.8% vs 9.9% severe, p = 0.034).
Conclusions
This pilot demonstrated that compliance was high with blood tests performed every
four months for ovarian cancer surveillance. Moreover, ROCA women had lower stress
scores over time than SOC women. Given the lack of clinical utility and poor compliance
shown with traditional ultrasound and CA125 tests, further investigation is warranted
of longitudinal biomarker surveillance for early detection of ovarian cancer.
Keywords
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Article info
Publication history
Published online: March 04, 2020
Accepted:
February 16,
2020
Received in revised form:
January 22,
2020
Received:
October 23,
2019
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
