A6

This is the first prospective randomized trial among newly diagnosed breast cancer patients to examine utilization of pre-surgical genetic counseling and testing for inherited mutations in the BRCA1 and BRCA2 (BRCA1/2) genes. Participants were women within six weeks of their breast cancer diagnosis who had not had definitive surgery and who were <50 years of age or ≥50 years of age with a first or second degree relative diagnosed with breast cancer <50 years or ovarian cancer at any age. Women completed a baseline interview and were randomized in a 2:1 ratio to receive rapid genetic counseling (RGC) or usual care (UC). Those in the RGC group were scheduled for a genetic counseling risk assessment by telephone or in person as quickly as possible after the baseline interview. Participants in the UC group were not scheduled for rapid genetic counseling but could self-refer for counseling on their own. To date, 236 newly diagnosed breast cancer patients have been identified as eligible. Among eligible patients, 155 (66%) have completed a baseline; and 137 (88%) agreed to be randomized (N=93 to RGC and N=44 to UC). In the RGC group, 80 women (86%) completed a genetic counseling risk assessment compared to 18 (41%) of the UC group (Χ2 (df=1) = 29.9, P<.0001). In terms of genetic testing, 41 participants (44%) randomized to RGC pursued BRCA1/2 testing compared to 16 participants (36%) randomized to UC (Χ2 (df=1) = 3.4, P=.06).
 >As predicted, among participants who pursued genetic counseling, those randomized to the RGC arm received counseling more quickly following their diagnosis. The average number of days from the date of diagnosis to the pre-test genetic counseling risk assessment was 28 (SD=19) in the RGC group versus 95 (SD=131) in the UC group (t(96)=4.45, p<.001). Similarly, among those who opted for testing, women in the RGC group received their tests results an average of 65 days (SD=59) after their diagnosis compared to 136 days (SD=156) post-diagnosis for the UC group (t(58)=2.52, p = 0.01).
 >In summary, these data demonstrate the feasibility of prospectively targeting rapid genetic counseling risk assessment to women at moderate to high risk of hereditary breast cancer within a short period of time following their breast cancer diagnosis. Participants randomized to RGC were more likely to complete genetic counseling and were more likely to undergo genetic testing. Further, the RGC intervention significantly expedited both genetic counseling and genetic testing - leading to more rapid receipt of counseling and test results for RGC participants. The surprisingly high rate of genetic testing among UC participants likely reflects changing standards of care for high-risk breast cancer patients. Future analyses will examine predictors of pre-surgical genetic counseling risk assessment and BRCA1/2 testing based on factors such as risk and distress.

Sixth AACR International Conference on Frontiers in Cancer Prevention Research-- Dec 5-8, 2007; Philadelphia, PA