Patients with unilateral breast cancer who underwent quantitative counseling with a personalized tool incorporating genetic testing results were better informed of their contralateral breast cancer risk compared with those who received standard counseling, according to results from the GET FACTS trial published by Weiss et al in JAMA Network Open. However, this improved knowledge did not appear to impact decisions to undergo contralateral prophylactic mastectomy.
“The contralateral breast cancer risk assessment tool is publicly available…,” the investigators noted. “Surgeons and genetic counselors may consider incorporating our contralateral breast cancer risk assessment tool into their preoperative consultations to help patients make informed decisions.”
Study Details
A total of 400 patients (mean age = 54 years) from a single tertiary referral center who underwent genetic testing and surgery were randomly assigned 1:1 to receive quantitative counseling with a visual decision support tool vs standard counseling; after randomization, 54 were excluded, resulting in a final study population of 346 patients. Personalized, age-specific contralateral breast cancer risk estimates were derived from the presence or absence of pathogenic breast cancer–associated variants and integrated into the tool.
Among 341 patients with available data, most were White (86.5%), with smaller proportions identifying as Asian or Pacific Islander (6.2%), Black (5.3%), or another race (2.1%). Ten percent of 330 patients with available data reported Ashkenazi Jewish ancestry. A total of 21.7% of the final study population had a first-degree relative with breast cancer.
The coprimary endpoints of the trial included numeric and qualitative self-assessments of patients’ personal contralateral breast cancer risk and their propensity to undergo contralateral prophylactic mastectomy following quantitative or standard genetic counseling. Contralateral prophylactic mastectomy rate was identified as the secondary endpoint.
Key Findings
According to the investigators, patients who received quantitative vs standard counseling more accurately reported their contralateral breast cancer risk estimates by univariate (coefficient = −9.39; 95% confidence interval [CI] = −14.86 to −3.93; P < .001) and multivariate (coefficient = −9.52; 95% CI = −16.50 to −2.51; P = .008) analyses. The type of counseling was not found to significantly impact perception of risk, self-reported propensity to undergo contralateral prophylactic mastectomy, or contralateral prophylactic mastectomy rates.
The investigators concluded: “In the GET FACTS randomized clinical trial of patients receiving genetic testing results before breast surgery with or without the use of a cancer risk counseling tool that specifically included contralateral breast cancer risk estimates, patients were more informed about their contralateral breast cancer risk after undergoing genetic counseling with the aid of our cancer risk counseling tool. Being able to more accurately report their personal contralateral breast cancer risk estimates did not seem to impact propensity to undergo contralateral prophylactic mastectomy, as reported propensity and contralateral prophylactic mastectomy rates were similar between arms.”
Anna Weiss, MD, of the University of Rochester, New York, is the corresponding author of the article in JAMA Network Open.
DISCLOSURE: The study was funded by an institutional research agreement with Myriad Laboratories Inc, the Brigham and Women’s Hospital Department of Surgery Robert T. Osteen Junior Fellowship Award, Dana-Farber Cancer Institute’s Friends of Dana-Farber Award, and the Susan F. Smith Center for Women’s Cancers Breast & Gynecologic Cancer Innovation Award. For full disclosures of the study authors, visit jamanetwork.com.
