Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer

Abstract

Purpose There is a growing demand for BRCA1/ 2 mutation ( BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with > 99% of patients expressing satisfaction with pre- and post- BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with > 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer.

Trial registration: ClinicalTrials.gov NCT02406235.

Fig 1.

ENGAGE trial procedures. (*) Blood sample collected and sent to an external laboratory or participating site for germline BRCA1/2 mutation testing, followed by genetics review; (†) clinical team includes the oncologist and/or nursing staff; (‡) end-of-study form is filled in by the clinical team to confirm the patient’s study status as either completed or not completed (includes loss to follow-up, death, patient decision).

Fig 2.

Turnaround times for each step of the streamlined BRCAm testing pathway. (*) Negative durations correspond to patients who consented to a BRCAm test before initial oncology team counseling or for whom the blood sample was taken before initial oncology team counseling. BRCAm, BRCA1/2 mutation.

Fig 3.

Patient satisfaction with pre-BRCA1/2 mutation (BRCAm) test counseling. Results shown for eight questions from the patients’ assessment of quality report form (Oncogenetic Counseling Elements Questionnaires) and for one summary question from the patients’ satisfaction report form (Satisfaction with Genetic Counseling Scale) before BRCAm testing. Q, question; VUS, variant of uncertain significance.

Fig 4.

Breakdown of BRCA1/2 mutation test results. VUS, variant of uncertain significance; Wt, wild type.