Nicoletta Colombo, MD
Patients and oncologists both expressed satisfaction with a streamlined, oncologist-led BRCA
mutation testing pathway in the ENGAGE study, leading researchers to conclude that pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors.
In the Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients with Ovarian Cancer (ENGAGE) study, more than 80% of oncologists agreed that the testing process worked well and that counseling patients on BRCA
testing was an efficient use of their time. More than 99% of patients expressed satisfaction with pre- and posttest counseling.1
“The streamlined BRCA
m testing model can shorten turnaround times by providing combined genetic testing and counseling, with high acceptance and satisfaction among both patients and clinical staff,” corresponding author Nicoletta Colombo, MD, European Institute of Oncology, University of Milan-Bicocca, and colleagues wrote.
“Development of local BRCA
m testing guidelines, involving oncologists, oncology nurses, and geneticists or genetic counselors and following a pathway 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,” added Colombo et al.
Treatment guidelines, including NCCN, recommend BRCA
for all patients diagnosed with epithelial ovarian cancer. Establishing the BRCA status in these patients provides useful information regarding the prognosis and clinical course of the disease, and it is essential in identifying patients most likely to benefit from PARP inhibitor therapy.
The recommendation is that patients should undergo genetic counseling both when genetic testing is offered to the patient and after genetic test results are disclosed. However, the limited number of genetic counselors puts a brake on the testing process and presents a potential barrier to the implementation of BRCA
testing for patients with ovarian cancer. Investigators in the ENGAGE study set out to determine if a streamlined testing approach could reduce turnaround times and ease the pressure on genetic counselors.
ENGAGE is an international, multicenter, prospective, observational study conducted at 26 sites in the United States (n = 11), Italy (n = 8), and Spain (n = 7).
Eligible adult women had a diagnosis of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were excluded if they had low-grade epithelial ovarian cancer or nonepithelial ovarian cancer, had undergone prior BRCA
testing, or were enrolled in an interventional clinical trial for any malignancy.
The clinical team, oncologists and oncology nurses, received training on discussing the role of BRCA
testing and on genetic counseling techniques, and provided patients with pretest counseling. a geneticist or genetic counselor provided additional pretest test counseling at patient request. After testing, the oncologist and/or geneticist reviewed and interpreted the test results and reported them to the patient.
Patients who received a positive BRCA
mutation result were encouraged to make an appointment with a geneticist or genetic counselor.
Fifty-two oncologists completed 110 satisfaction survey questionnaires. While only oncologists conducted pretest counseling in Europe, nurses in the United States were more likely to perform the pretest counseling than oncologists (59.3% vs 40.7%). However, nurses were not surveyed for their reactions to the testing and counseling process.
Seven hundred patients enrolled from April 2015 to September 2016 and were included in this analysis. Ninety percent of patients completed the study.
The main analysis included 530 Satisfaction with Genetic Counseling Scale (SGCS) questionnaires and 514 Oncogenetic Counseling Elements administered prior to BRCA mutation testing, and 414 SGCS questionnaires and 414 Modified Royal Marsden Patient Satisfaction Questionnaires administered after testing.
The median overall turnaround time for test results was 9.1 weeks with a median turnaround of 4.1 weeks (range, 0.9-37.1) in the United States. Analysis of each step of the testing pathway showed that the overall turnaround time was driven mainly by the time from the collection of the blood sample for BRCA
testing to the patient’s receipt of the test results (median, 8.6 weeks; range, 0.7-35.6).
Overall, 99.2% of patients were satisfied with pretest counseling and 99.8% of patients were satisfied with posttest counseling by a geneticist/genetic counselor or oncologist. Mean SGCS scores before and after testing were >3.5 for all 6 dimensions, with minimal differences seen between pre- and posttesting.