ENGAGE: Evaluation of a streamlined oncologist-led BRCA mutation (BRCAm) testing and counselling model for patients with ovarian cancer.

5559 Background: Short BRCAm testing turnaround times (TAT) are crucial to making timely treatment decisions for patients (pts) with ovarian cancer. ENGAGE (NCT02406235; D0816R00006) evaluated a streamlined, oncologist-led germline BRCAm testing model, piloted by the Institute of Cancer Research and the Royal Marsden Hospital, London, UK. Results presented are from the final analysis (data cut-off: 30 Sep 2016). Methods: This prospective, observational study enrolled pts with ovarian cancer across sites in the US (n = 11), Italy (n = 8) and Spain (n = 7). Oncologists and nurses at participating sites were trained on genetic counselling techniques relating to BRCAm testing. Primary endpoints were BRCAm testing TAT (time from initial counselling to the provision of test results or post- BRCAm test counselling [whichever occurred latest]); pts’ satisfaction with the oncogenetic testing model, evaluated using pre- and post- BRCAm testing surveys; and clinicians’ opinion on the value of this new testing pathway, evaluated using a post- BRCAm testing survey. Results: For the 700 evaluable pts enrolled (US = 317; EU = 383), pre- BRCAm testing counselling was carried out by either an oncologist (40.7%) or clinical staff (nurse or research coordinator; 59.3%) in the US, and only by oncologists in the EU. The median overall TAT was 9.1 weeks (all pts), with 12.0 weeks in Spain, 20.4 weeks in Italy (17.4 weeks EU median) and 4.1 weeks in the US. The differences were mainly due to the time from BRCAm testing to obtaining the test results. Satisfaction with the overall counselling was high amongst pts, with a mean dimension score rating of 3.8/4 (where 4.0 = highest satisfaction). 93.6% of pts were happy to have received genetic testing as part of an existing oncologist appointment, and more than 80% of oncologists were satisfied with the screening process, agreeing that it was an efficient use of their time. Conclusions: The ENGAGE study results show that a streamlined oncologist-led BRCAm testing model can offer reduced TAT and high levels of satisfaction amongst pts and clinicians. The success of this model is enhanced by access to a BRCAm testing facility, from which results can be obtained quickly. Clinical trial information: NCT02406235; D0816R00006.