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J Clin Oncol. 2018 May 1;36(13):1300-1307. doi: 10.1200/JCO.2017.76.2781. Epub 2018 Mar 20.

Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer.

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Nicoletta Colombo, University of Milan-Bicocca; Nicoletta Colombo, Istituto Europeo di Oncologia, Milan; Giovanni Scambia, Università Cattolica del Sacro Cuore di Roma, Rome; Sandro Pignata, Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G Pascale IRCCS, Naples, Italy; Gloria Huang, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx; Eva Chalas, Winthrop University Hospital, Mineola, NY; James Fiorica, Sarasota Memorial Hospital, Sarasota, FL; Linda Van Le, University of North Carolina School of Medicine, Chapel Hill, NC; Sharad Ghamande, The Georgia Cancer Center at Augusta University, Augusta; Andrew Green, Northeast Georgia Medical Center, Gainesville, GA; Santiago González-Santiago, Hospital San Pedro de Alcántara, Cáceres; Isabel Bover, Hospital Son Llàtzer, Palma; Begoña Graña Suárez, University Hospital A Coruña, Sergas, Spain; Philippe Huot-Marchand and Yann Bourhis, Mapi Real World Evidence, Lyon, France; Sudeep Karve, AstraZeneca, Gaithersburg, MD; and Christopher Blakeley, AstraZeneca, Cambridge, United Kingdom.


Purpose There is a growing demand for BRCA1/ 2 mutation ( BRCAm) testing in patients with ovarian cancer; however, the limited number of genetic counselors presents a potential barrier. To facilitate more widespread BRCAm testing in ovarian cancer, pretest counseling by the oncology team could shorten testing turnaround times and ease the pressure on genetic counselors. Patients and Methods The prospective, observational Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) study evaluated a streamlined, oncologist-led BRCAm testing pathway. The analysis population comprised 700 patients with ovarian cancer at 26 sites in the United States, Italy, and Spain. The primary objectives were to assess turnaround time and, using questionnaires, to evaluate stakeholder satisfaction (patients, oncologists, and geneticists or genetic counselors) with the oncologist-led BRCAm testing pathway. Results The median overall turnaround time was 9.1 weeks (range, 0.9 to 37.1 weeks), with median turnaround times in the United States, Italy, and Spain of 4.1 weeks (range, 0.9 to 37.1 weeks), 20.4 weeks (range, 2.9 to 35.4 weeks), and 12.0 weeks (range, 2.0 to 36.7 weeks), respectively. Patient satisfaction with the oncologist-led BRCAm testing pathway was high, with > 99% of patients expressing satisfaction with pre- and post- BRCAm test counseling. Oncologist satisfaction with the BRCAm testing pathway was also high, with > 80% agreeing that the process for performing BRCAm testing worked well and that counseling patients on BRCAm testing was an efficient use of their time. Oncologists expressed higher levels of satisfaction with the BRCAm testing pathway than did geneticists or genetic counselors. Conclusion The results of the ENGAGE study demonstrate that an oncologist-led BRCAm testing process is feasible in ovarian cancer. Development of local BRCAm testing guidelines 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.


[Indexed for MEDLINE]

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