Impact of the 21-Gene Recurrence Score Assay Compared With Standard Clinicopathologic Guidelines in Adjuvant Therapy Selection for Node-Negative, Estrogen Receptor-Positive Breast Cancer
chemotherapy; clinical-trials; fluorouracil; gene-expression; Oncology; prognostic signature; randomized-trials; sequential methotrexate; Surgery; tamoxifen; validation; women
Background. The development of multigene assays has proved useful in the clinical management of early-stage breast cancer. The 21-gene recurrence score (RS) assay has been shown to quantify risk of distant recurrence and predict chemotherapy benefit in node-negative and node-positive, estrogen-receptor (ER)-positive breast cancer patients. Small, single-institution series have shown that, compared with standard clinicopathologic criteria, use of RS significantly affects adjuvant chemotherapy recommendations. Methods. We performed a retrospective review of RS use and its effect on chemotherapy recommendations in node-negative, ER-positive breast cancer patients at a tertiary care teaching hospital. Patient and tumor characteristics and adjuvant treatment information were obtained on 183 patients with RS results between January 2004 and October 2009. Risk categories were assigned based on the RS and on standard clinicopathologic criteria according to guidelines from NCCN, St. Gallen, and Adjuvant!. Results. A total of 14 patients were excluded for negative ER status (n = 2), insufficient data (n = 4), inclusion in TAILORx trial (n = 7), and recurrent breast cancer (n = 1), leaving 169 patients in the cohort. RS use increased 3-fold over the study period (from 18% in 2004 to 50% in 2009). Tumor grade, ER status, and PR status were significantly correlated with RS category. Overall concordance between RS and NCCN, St. Gallen, and Adjuvant! was 10, 48, and 50%, respectively. Depending on the guideline used for comparison, adjuvant therapy recommendations changed with the addition of the RS in 27-74% of cases. Conclusions. RS use is increasing, and the assay significantly reduced adjuvant chemotherapy utilization in node-negative, ER -positive breast cancer patients.
Partin J F; Mamounas E P
Annals of Surgical Oncology
2011
2011-11
Journal Article
<a href="http://doi.org/10.1245/s10434-011-1698-z" target="_blank" rel="noreferrer noopener">10.1245/s10434-011-1698-z</a>
Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: Results from five National Surgical Adjuvant Breast and Bowel Project randomized clinical trials
chemotherapy; irradiation; Oncology; postmastectomy radiotherapy; postoperative radiotherapy; premenopausal women; radiation-therapy; receptor-positive tumors; risk-factors; sequential methotrexate; tamoxifen
Purpose Lymph node (LN)-negative breast cancer tumors >= 5 cm occur infrequently, and their optimal management is not well defined. In this study, we assess patterns of locoregional failure (LRF) in LN-negative patients who underwent mastectomy, either with or without adjuvant chemotherapy or hormonal therapy and without postmastectomy radiation therapy (PMRT). Patients and Methods Of 8,878 breast cancer patients enrolled onto National Surgical Adjuvant Breast and Bowel Project B-13, B-14, B-19, B-20, and B-23 node-negative trials, 313 had tumors that were 5 cm or larger (median, 5.5 cm; range, 5.0 to 15.5 cm) at pathology and were treated by mastectomy. Median follow-up time was 15.1 years. Therapy included adjuvant chemotherapy in 34.2% of patients; tamoxifen in 21.1%; chemotherapy plus tamoxifen in 19.2%; and no systemic therapy in 25.5%. Results Twenty-eight patients experienced LRF. The overall 10-year cumulative incidences of isolated LRF, LRF with and without distant failure (DF) and DF alone as first event were 7.1%, 10.0%, and 23.6%, respectively. cumulative incidences for isolated LRF as first event for patients with tumors of 5 cm or more than 5 cm were 7.0% and 7.2%, respectively (P=.9). For patients who underwent no systemic treatment, chemotherapy alone, tamoxifen alone, of chemotherapy plus tamoxifen, the incidences were 12.6%, 5.6%, 4.6%, and 5.3%, respectively (P=.2). The majority of failures occurred on the chest wall (24 of 28 patients). Multivariate analysis did not identify significant prognostic factors for LRF. Conclusion In patients with LN-negative tumors >= 5 cm who are treated by mastectomy with or without adjuvant systemic therapy and no PMRT, LRF as first event remains low. PMRT should not be routinely used for these patients.
Taghian A G; Jeong J H; Mamounas E P; Parda D S; Deutsch M; Costantino J P; Wolmark N
Journal of Clinical Oncology
2006
2006-08
Journal Article
<a href="http://doi.org/10.1200/jco.2006.06.9054" target="_blank" rel="noreferrer noopener">10.1200/jco.2006.06.9054</a>