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Journal of Clinical Oncology, Vol 23, No 13 (May 1), 2005: pp. 3165-3166 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.05.157
Genetic Cancer Risk Assessment in the Newly Diagnosed Breast Cancer Patient Is Useful and Possible in PracticeCity of Hope Comprehensive Cancer Center, Duarte, CA To the Editor: We read with great interest the article by Schwartz et al1 concerning a prospective trial of counseling and BRCA testing of newly diagnosed breast cancer patients. They are to be applauded for their attention to the possible value of urgent genetic cancer risk assessment (GCRA) to allow women to consider prevention while making decisions about surgical management of breast cancer. It is likely that the availability of free (grant-funded) GCRA and rapid BRCA gene analysis facilitated the timely integration of testing in the compressed time frame of definitive management of newly diagnosed breast cancer. However, as pointed out by Dr Daly in the accompanying editorial,2 free genetic counseling is not typically available in standard practice, and rapid BRCA testing is costly (more than $1,000 premium on top of the almost $3,000 base-test cost). Although the authors acknowledged concern over the generalizability of their study findings for this reason, Dr Daly additionally expressed concern over possible treatment delays. Furthermore, it is not clear what the time frame was for study accrual, raising concern about the possible influence of shifting management recommendations based on rapidly emerging clinical data. Our group conducted a study of the effect of standard GCRA and conventional (nonexpedited) BRCA testing on surgical decisions for 37 newly diagnosed clinically limited-stage breast cancer patients over a 1-year sampling frame.3 The mean elapsed time between breast cancer diagnosis and initiation of GCRA was 27 days (range, 3 to 72 days). The GCRA protocol consisted of pretest counseling, obtaining informed consent, commercial BRCA genotyping (standard 3-to-4–week turnaround), which often required insurance preauthorization, and a subsequent clinic session for individualized post-test counseling focused on the formation of a definitive combined treatment and risk reduction management plan. We determined that the optimum window of opportunity for GCRA to influence surgical decisions is during adjuvant chemotherapy, which is prescribed for most premenopausal breast cancer patients; then the definitive decision occurs after complete tumor resection (lumpectomy or excisional biopsy) and before the initiation of radiotherapy if breast-conserving therapy is planned. More challenging scenarios include the circumstances of involved surgical margins after lumpectomy or after core biopsy, but before definitive tumor excision. There was an adequate window of time for GCRA for 10 of 11 core biopsy patients in our series because they were receiving neoadjuvant chemotherapy, whereas in the other patient, surgery was scheduled for 3 to 4 weeks hence. Table 1 lists the timing of GCRA in the context of diagnosis and treatment of 32 of the 37 patients who proceeded with testing in our study. With the exception of one patient who chose to delay radiation therapy pending genetic testing results, there were no treatment delays to accommodate GCRA. There were no delays in surgical procedures or chemotherapy for any of the women.
Because effective treatment of the current breast cancer is likely to have the greatest impact on overall survival, we agree that definitive therapy should not be delayed for GCRA. Most importantly, risk-appropriate care was chosen in the majority of patients (30 of 32 patients) in our prospective series. The rate of contralateral risk-reduction surgery in the BRCA genotype and phenotype negative patients (2 [8%] of 25 patients) was considerably lower than in the study (33 [24%] of 136 patients), wherein results disclosure and post-test counseling was apparently administered via telephone by the genetic counselor.1 This suggests the need for direct physician involvement in the post-test counseling and prospective assessment of phenotype in BRCA-negative cases to provide a firm basis for recommendations. Our study shows that even with the real life circumstances of requirements for insurance preauthorization for both testing and genetic counseling and standard turnaround times associated with nonexpedited BRCA-mutation testing (3 to 4 weeks), it is feasible to integrate GCRA into the management of women with newly diagnosed breast cancer. Analysis of long-term outcomes including quality of life is ongoing. Furthermore, it is possible that timely GCRA may actually decrease the rate of inappropriate bilateral mastectomy for young newly diagnosed breast cancer patients. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.
REFERENCES
1. Schwartz MD, Lerman C, Brogan B, et al: Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients. J Clin Oncol 22:1823-1829, 2004
2. Daly MB: Tailoring breast cancer treatment to genetic status: The challenges ahead. J Clin Oncol 22:1776-1777, 2004
3. Weitzel JN, McCaffrey SM, Nedelcu R, et al: Effect of genetic cancer risk assessment on surgical decisions at breast cancer diagnosis. Arch Surg 138:1323-1328, 2003
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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