Streamlined BRCA Testing Program Shows Promise in Ovarian Cancer

Giovanni Scambia, MD

An interim analysis of an ongoing study showed potential for reducing time and improving acceptance of testing and counseling for patients with ovarian cancer, according to a report presented at the ESMO Annual Congress in Copenhagen.

The analysis showed a median turnaround time of 5.6 weeks for test results, compared with a recent estimate of 12 to 15 weeks in the United Kingdom. In the United States, participating sites met the target turnaround time of 4 weeks. European participants, had a median turnaround time of 9.4 weeks.

“Integrating BRCA testing into existing oncology clinics and providing genetic counseling in parallel with genetic testing produced high acceptance and satisfaction levels for both patents and clinicians,” Giovanni Scambia, MD, a professor of obstetrics and gynecology at Sacred Heart Catholic University in Rome, and colleagues concluded in a poster presentation.

Participating oncologists said the testing is important for patients with ovarian cancer, and the BRCA testing was an efficient use of their time. Moreover, patient satisfaction rates exceeded 90%.

“With widespread use, this BRCA testing model has the potential to allow faster treatment decisions and better use of resources in the treatment of patients with ovarian cancer,” Scambia said.

BRCA testing can play a major role in informing treatment decisions for patients with ovarian cancer. In about 15% of cases, ovarian cancer harbors a germline BRCA mutation that can drive defective homologous recombination repair, which often is amenable to treatment with a PARP inhibitor. However, fewer than 30% of patients in developed nations are offered BRCA testing.

A family history of ovarian or breast cancer often is a prerequisite for BRCA testing. However, as many as half of patients with germline BRCA mutations do not have a first- or second-degree relative with either disease, Scambia noted.

Prolonged delays in test turnaround time have arisen from several factors, including lack of consistent testing guidelines and lengthy wait periods to see genetic counselors.

To increase use of BRCA testing, streamline the process, and improve patient satisfaction, healthcare professionals at 26 sites in the U.S. and Europe have developed a novel oncologist-led testing model. Scambia reported interim findings from an ongoing evaluation of the system.

Genetic counseling and BRCA testing opportunities were incorporated into clinic visits. Oncologists and nurses received training that provided background about the role of BRCA testing in ovarian cancer and in the use of certain genetic counseling techniques.

A pilot study of the program, conducted by the Institute of Cancer Research and the Royal Marsden Hospital in London, suggested test turnaround time could be reduced to 4 weeks in association with high rates of patient and oncologists satisfaction with the testing process and counseling.

The ongoing ENGAGE study was developed to validate the findings from the pilot study. Data analysis included 710 patients with advanced ovarian cancer. The primary outcomes of interest were: BRCA testing turnaround time, from initial clinical team counseling until provision of test results or counseling to the patient; patient assessment of the testing/counseling model; and clinician opinion of the value of the oncogenetic testing process.

Following patient consent, patients received oncologist-led pre-test counseling, after which patients completed surveys related to their satisfaction with the testing and counseling process. Optionally, patients could receive additional pretest counseling from geneticists.

After testing and presentation of the results to the clinical team, patients received additional counseling from their oncologists or from a geneticist. Patients then complete post-test surveys of their satisfaction with the process, and oncologists and geneticists also completed assessments of the testing process.

Scambia’s presentation was based on complete data for 444 patients. The preliminary data showed that the U.S. sites met the goal of a median turnaround time of 4 weeks, whereas the turnaround time was more than twice as long. The median time from test completion to patient receipt of results was 3.1 weeks. The median time from pretest counseling to post-test counseling was 7.9 weeks, a value that did not include 172 patients who did not require post-test counseling.

Patient satisfaction rate for pretest counseling was 98.5%, and 92.3% said the post-test counseling session helped them understand the BRCA test results and its implications for them and their families. Additionally, 92% of patients (N=350) said they were happy the test was performed during a scheduled oncology visit instead of a separate visit, and 96% of respondents said they were happy with the decision to be tested.

Scambia and colleagues surveyed 52 oncologists who participated in the program. Among oncologists who counseled more than eight patients, 93.1% said BRCA testing is “very important” for ovarian cancer patients. Additionally, 90% said the time allocated to counseling was an efficient use of their time.

More than 90% of BRCA tests were performed at central laboratories, and test results were conveyed by oncologists in 44.8% of cases, nurses in 31.5%, and geneticists in 23.5%. Test results were positive for BRCA mutations in 10% of cases.

The streamlined process evaluated in the ENGAGE study represents one way to increase BRCA testing and counseling for patients with ovarian cancer. However, the oncologist-led program is not yet generalizable to the broader population of patients with a positive family history, said invited discussant Florence Joly, MD, a medical oncologist at the Francois Baclesse Center in Caen, France.

Joly cited a need for closer evaluation and longer follow-up, specifically citing the quality of training for genetic counseling and presentation of test results as issues that require careful study. She also questioned why 40% of patients with positive tests did not receive post-test counseling by the genetics team.

Scambia G, Chalas E, Huang G, et al. A novel oncologist-led BRCA1/2 germline mutation (gBRCAm) testing and counselling model for patients with ovarian cancer: Interim results from the ENGAGE (NCT02406235) study. Presented at: 2016 ESMO Congress; October 7-11 2016; Copenhagen, Denmark. Abstract LBA34