1/26/2024 0 Comments Endo predict![]() All women were postmenopausal and received 5 years of adjuvant endocrine therapy only ( 19, 20). Patients in both trials, ABCSG-6 or ABCSG-8, did not receive chemotherapy. ![]() This analysis included patients with early-stage ER-positive, HER2-negative breast cancer who were enrolled in the randomized phase III ABCSG-6 (tamoxifen-only arm) or ABCSG-8 (tamoxifen-only and tamoxifen+anastrozole arms) trials. Although some assays have been shown to be strong predictors of late recurrence 5 to 10 years after diagnosis ( 13–17), additional studies with longer term follow-up are necessary to more robustly evaluate the use of these molecular assays for extended endocrine therapy decision making. In addition, a recent study highlighted the long-term risk of recurrence and death from breast cancer, with a 13% risk of recurrence 5 to 20 years after diagnosis for women with node-negative disease who received 5 years of endocrine therapy ( 12). Although this supports the use of prognostic molecular assays in informing initial treatment decisions, additional studies are needed to support their use in clinical decision making for patients with node-positive disease. For example, several assays have been validated to predict the risk of 10-year distant recurrence ( 3, 4). With the growing number and complexity of treatment decisions for women with ER-positive, HER2-negative breast cancer, there is an increased need for versatile and reliable prognostic assays. With no established prognostic factors for this patient population, professional society guidelines continue to state that all women may “consider” extending endocrine therapy after 5 years and provide no clear guidance on which patients may safely avoid such treatment ( 1). ![]() However, the authors called out that additional work is needed to investigate this clinicopathologic tool relative to and in combination with molecular assays. To this end, recently a nomogram was developed to combine nodal status, tumor size, tumor grade, and age (Clinical Treatment Score post-5 years, CTS5) that was significantly prognostic for 5- to 10-year recurrence in women who received 5 years of endocrine therapy ( 11). There is growing consensus that some patients may be at low enough risk to safely avoid extended endocrine therapy, with recent efforts aimed at identifying reliable prognostic factors. In light of this conflicting data regarding the clinical benefits of extended endocrine therapy, treatment decisions at the 5-year time point are not straightforward. Another randomized study of patients who received 5 years of endocrine therapy (ABCSG-16) showed that 5 years of extended anastrozole therapy resulted in added toxicity and did not improve disease-free survival compared with 2 years of extended therapy ( 10). In addition, a recent large, randomized, placebo-controlled trial (NSABP-B42) showed that survival was not significantly improved among women with ER-positive, HER2-negative disease who received 10 years of endocrine therapy compared with 5 years ( 9). However, many of these trials are confounded by the inclusion of patients who received adjuvant chemotherapy or by unknown hormone receptor status. Several trials have demonstrated improved survival among women who received endocrine therapy for 10 years versus 5 years ( 5–8). Conflicting data have emerged regarding the efficacy of extending endocrine therapy beyond 5 years and, as a result, the optimal duration and regimen of adjuvant endocrine therapy is not clear. Women with ER-positive, HER2-negative breast cancer now face a second treatment decision 5 years after diagnosis: whether or not to continue endocrine therapy. Validation of these molecular assays for risk of late recurrence and in women with node-positive disease is necessary to evaluate their utility to inform treatment decisions regarding adjuvant chemotherapy and extended endocrine therapy for women with ER-positive, HER2-negative breast cancer. The advent of prognostic molecular assays has improved the accuracy of risk assessment at diagnosis compared with clinical measures only however, there are limited data regarding the use of prognostic molecular assays for women with node-positive disease and for late recurrence. This risk has been traditionally evaluated using standard clinical measures, such as tumor grade, tumor size, age, and Ki67 status. These treatment decisions are based on a patient's risk of early and late distant recurrence, respectively. ![]() Women with estrogen receptor (ER)-positive, HER2-negative breast cancer are faced with treatment decisions at the time of diagnosis (adjuvant chemotherapy) and 5 years after diagnosis (extended endocrine therapy).
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