LBA34 - A novel oncologist-led BRCA1/2 germline mutation (gBRCAm) testing and counselling model for patients with ovarian cancer: Interim results from the...

Date 08 October 2016
Event ESMO 2016 Congress
Session Gynaecological cancers
Topics Ovarian Cancer
Presenter GIOVANNI Scambia
Citation Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435
Authors G. Scambia1, E. Chalas2, G. Huang3, B. Graña Suárez4, S. González-Santiago5, N. Colombo6, S. Pignata7, P. Huot-Marchand8, S. Karve9, C. Blakeley10
  • 1Gynecology Oncology, Policlinico Universitario A. Gemelli Università Cattolica del Sacro Cuore, 00168 - Roma/IT
  • 2,, Winthrop University Hospital, Mineola/US
  • 3,, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx/US
  • 4,, Hospital Teresa Herrera (CHU A Coruña), A Coruna/ES
  • 5,, Hospital San Pedro de Alcántara (Complejo Hospitalario de Cáceres), Cáceres/ES
  • 6,, Istituto Europeo Oncologia (IEO), Milano/IT
  • 7,, Istituto Tumori Pascale di Napoli, Napoli/IT
  • 8,, Mapi SAS, Lyon/FR
  • 9,, AstraZeneca, Gaithersburg/US
  • 10,, AstraZeneca, Cambridge/GB

Abstract

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.