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.
J Clin Oncol. 2018 May 1;36(13):1300-1307. doi: 10.1200/JCO.2017.76.2781. Epub 2018 Mar 20.
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.
目的 对卵巢癌患者进行 BRCA1/2 突变（BRCAm）检测的需求日益增长；然而，遗传咨询师人数有限，这可能成为一个潜在的障碍。为了促进卵巢癌中更广泛地进行 BRCAm 检测，肿瘤团队的检测前咨询可以缩短检测周转时间，并减轻遗传咨询师的压力。
患者和方法 前瞻性、观察性的 Evaluating a Streamlined Onco-genetic BRCA Testing and Counseling Model Among Patients With Ovarian Cancer (ENGAGE) 研究评估了一种简化的、由肿瘤学家主导的 BRCAm 检测途径。该分析人群包括来自美国、意大利和西班牙的 26 个地点的 700 名卵巢癌患者。主要目的是评估周转时间，并使用问卷评估患者、肿瘤学家和遗传学家/遗传咨询师对肿瘤学家主导的 BRCAm 检测途径的满意度。
结果 总体平均周转时间为 9.1 周（范围，0.9 至 37.1 周），美国、意大利和西班牙的中位周转时间分别为 4.1 周（范围，0.9 至 37.1 周）、20.4 周（范围，2.9 至 35.4 周）和 12.0 周（范围，2.0 至 36.7 周）。患者对肿瘤学家主导的 BRCAm 检测途径的满意度很高，超过 99%的患者对 BRCAm 检测前后的咨询表示满意。肿瘤学家对 BRCAm 检测途径的满意度也很高，超过 80%的肿瘤学家认为进行 BRCAm 检测的过程运作良好，对患者进行 BRCAm 检测咨询是对他们时间的有效利用。肿瘤学家对 BRCAm 检测途径的满意度高于遗传学家或遗传咨询师。
结论 ENGAGE 研究的结果表明，肿瘤学家主导的 BRCAm 检测过程在卵巢癌中是可行的。制定类似于本研究中使用的当地 BRCAm 检测指南可以在卵巢癌患者的治疗决策中实现更快的决策，并更好地利用资源。
