Kate Watabayashi

Use of CA125 and HE4 Serum Markers to Predict Ovarian Cancer in Elevated-Risk Women

Background: Serum markers are used before pelvic imaging to improve specificity and positive predictive value (PPV) of ovarian cancer multimodal screening strategies. Methods: We conducted a randomized controlled pilot trial to estimate surgical PPV of a “2 of 3 tests positive” screening rule, and to compare use of HE4 as a first-line (Arm 1) versus a second-line (Arm 2) screen, in women at high and elevated risk for epithelial ovarian cancer (EOC) at five study sites. Semiannual screening was offered to 208 women ages 25 to 80 years with deleterious BRCA germline mutations and to 834 women ages 35 to 80 years with pedigrees suggesting inherited susceptibility. Annual screening was offered to 130 women ages 45 to 80 years (Risk Group 3) with epidemiologic and serum marker risk factors. Rising marker levels were identified using the parametric empirical Bayes algorithm. Results: Both strategies yielded surgical PPV above 25%. Protocol-indicated surgery was performed in 6 women, identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33% (95% confidence interval: 4%–78%), 25% in Arm 1 and 50% in Arm 2. Surgical consultation was recommended for 37 women (26 in Arm 1 and 11 in Arm 2). On the basis of 12 women with at least 2 of 3 tests positive (CA125, HE4, or imaging), an intent-to-treat analysis yielded PPV of 14% in Arm 1 and 20% in Arm 2. Conclusions: Positive screens were more frequent when HE4 was included in the primary screen. Impact: HE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen. Cancer Epidemiol Biomarkers Prev; 23(7); 1383–93. ©2014 AACR.

Cancer risk awareness and concern among women with a family history of breast or ovarian cancer

Women with a documented deleterious mutation in BRCA1 or BRCA2 are at substantially elevated risk for ovarian cancer. To understand what percentage of women with high-risk family histories know their risk is elevated we surveyed 1,885 women with a high- or moderate-risk family history and no personal history of breast or ovarian cancer, and asked about their perceived risk of breast and ovarian cancer. Among high-risk women, fewer than 20% reported use of genetic counseling, and knowledge of elevated risk of ovarian cancer was low. Prior genetic counseling was associated with greater perceived risk for ovarian cancer. Results suggest that most high-risk women (>75%) do not know their risk for ovarian cancer. Identification of potentially high-risk women for referral to genetic counseling may improve informed ovarian cancer risk management.

Pilot Feasibility Study of an Oncology Financial Navigation Program

BACKGROUND Few studies have reported on interventions to alleviate financial toxicity in patients with cancer. We developed a financial navigation program in collaboration with our partners, Consumer Education and Training Services (CENTS) and Patient Advocate Foundation (PAF), to improve patient knowledge about treatment costs, provide financial counseling, and to help manage out-of-pocket expenses. We conducted a pilot study to assess the feasibility and impact of this program. METHODS Patients with cancer received a financial education course followed by monthly contact with a CENTS financial counselor and a PAF case manager for 6 months. We measured program adherence, self-reported financial burden and anxiety, program satisfaction, and type of assistance provided. RESULTS Thirty-four patients (median age, 60.5 years) were consented (85% white and 50% commercially insured). Debt, income declines, and loans were reported by 55%, 55%, and 30% of patients, respectively. CENTS counselors assisted most often with budgeting, retirement planning, and medical bill questions. PAF case managers assisted with applications for appropriate insurance coverage, cost of living issues (eg, housing, transportation), and disability applications. High financial burden and anxiety about costs (4 or 5 on a Likert scale) were reported at baseline by 37% and 47% of patients, respectively. Anxiety about costs decreased over time in 33% of patients, whereas self-reported financial burden did not substantially change. CONCLUSION Implementing an oncology financial navigation program is feasible, provides concrete assistance in navigating the cost of care, and mitigates anxiety about costs in a subset of patients. Future work will focus on measuring the programs impact on financial and clinical outcomes.

The effect of referral for genetic counseling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial.

Guidelines recommend genetic counseling and testing for women who have a pedigree suggestive of an inherited susceptibility for ovarian cancer. The authors evaluated the effect of referral to genetic counseling on genetic testing and prophylactic oophorectomy in a randomized controlled trial.

Abstract POSTER-CTRL-1214: Systematic identification of high risk women for genetic counseling and surgical prevention of ovarian cancer

Abstracts: 10th Biennial Ovarian Cancer Research Symposium; September 8-9, 2014; Seattle, WA Objectives: Information technology provides an opportunity for systematic identification of high-risk patients for appropriate referral. We conducted a randomized controlled trial to test whether routine identification of women at high risk for epithelial ovarian cancer using an electronic database and subsequent referral to genetic counseling would promote genetic testing and prophylactic surgery. Methods: Electronic data in a mammography reporting system from a large community hospital in Seattle was used to identify women at increased risk for ovarian cancer based on personal and family cancer history. Following secondary confirmation of eligibility and consent, women were randomly assigned to an intervention consisting of a genetic counseling referral, or to standard clinical care. Results: A total of 458 women were enrolled. Compared to standard clinical care systemic identification and referral of high risk women to genetic counseling increased the number of women who elect to undergo genetic testing (75 vs 20, p<0.005) and prophylactic surgery (OR: 3.5, p=0.05). Conclusions: Our results demonstrated that systematic identification of high-risk women for referral to genetic counseling is feasible and increases utilization of risk-appropriate prevention strategies. Citation Format: Robert Resta, MS CGC; Charles W. Drescher, MD; David Beatty, MD; M Robyn Andersen, PhD; Kate Watabayashi, BA; Jason Thorpe, MSc; Hannah Purkey, BS; Jessica Chubak, PhD; Nancy Hanson, MS CGC; Diana S.M. Buist, MPH PhD; Nicole Urban, ScD. Systematic identification of high risk women for genetic counseling and surgical prevention of ovarian cancer [abstract]. In: Proceedings of the 10th Biennial Ovarian Cancer Research Symposium; Sep 8-9, 2014; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2015;21(16 Suppl):Abstract nr POSTER-CTRL-1214.