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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
Background: Targeted therapies mean that gBRCAm
testing and genetic counselling are becoming routine in ovarian cancer
management. ENGAGE is the first real-world study
to evaluate an oncologist-led testing model first used
at the Institute of Cancer Research and Royal Marsden Hospital, London,
UK.
Methods: This ongoing
prospective, observational study was conducted across sites in the US
(11), Italy (8) and Spain (7), enrolling
710 adult patients with epithelial ovarian, fallopian
tube or primary peritoneal cancer. Baseline demographic, clinical and
therapeutic data, and primary outcome data (gBRCAm testing turnaround time [TAT], outcome of BRCAm test, and patient and oncogenetic counsellor's satisfaction surveys on the model), were collected. Physicians completed
training on BRCAm counselling.
Results: This interim
analysis evaluated data from 444 patients (US 297; EU 147) with mean age
63.7 (SD 10.6) years, of whom 38% were
newly diagnosed and 38% had family history of breast
or ovarian cancer. Median time since diagnosis was 0.8 years. Pre-BRCA test counselling was provided by oncologists (40%) or nurses (56%) in the US and by oncologists in Europe. Only 1 patient
requested additional pre-test counselling. Mean TAT from initial counselling to BRCA test results/oncogenetic counselling was 6.7 (SD 4.5) weeks: 5.1 (SD 3.7) weeks in the US and 10.0 (SD 4.2) weeks in the
EU. BRCA testing was mainly performed in a central laboratory (91%). BRCAm was identified in 10% of patients. Mean patient-reported fulfilment of expectations and overall satisfaction with counselling
were both >3.7/4 pre-/post-BRCA testing. 92% were satisfied to have the genetic test at an existing rather than a separate visit. Over 80% of oncologists
considered the BRCA-testing process to work well and that counselling patients on BRCA testing was an efficient use of their time.
Conclusions: Interim results
showed that the novel testing model results in reduced timelines and
high acceptance and satisfaction levels
in both patients and staff, with potential for quicker
treatment decisions and better use of resources. The time to receive
BRCAm test results was the major variable.
Clinical trial identification: NCT02406235
Legal entity responsible for the study: AstraZeneca
Funding: AstraZeneca
Disclosure: E. Chalas:
Honoraria, speakers bureau, research funding, travel, accommodation,
expenses – AstraZeneca. N. Colombo: Advisory
boards and symposia speaker – AstraZeneca. S. Pignata:
Honoraria – AstraZeneca. P. Huot-Marchand: Mapi - subcontractors for
AstraZeneca. S. Karve, C. Blakeley: Employee of
AstraZeneca and own AstraZeneca stock. All other authors have declared
no
conflicts of interest.
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