Ivana Sestak1, Jack Cuzick2, Mitch Dowsett2, Elena Lopez-Knowles2, Martin Filipits2, Peter Dubsky2, John Wayne Cowens2, Sean Ferree2, Carl Schaper2, Christian Fesl2, Michael Gnant2. 1. Ivana Sestak, Jack Cuzick, Queen Mary University; Mitch Dowsett, Elena Lopez-Knowles, Royal Marsden Hospital, London, United Kingdom; Martin Filipits, Peter Dubsky, Michael Gnant, Medical University of Vienna; Christian Fesl, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria; John Wayne Cowens, Sean Ferree, NanoString Technologies, Seattle, WA; and Carl Shaper, MyRAQA, Redwood Shores, CA. i.sestak@qmul.ac.uk. 2. Ivana Sestak, Jack Cuzick, Queen Mary University; Mitch Dowsett, Elena Lopez-Knowles, Royal Marsden Hospital, London, United Kingdom; Martin Filipits, Peter Dubsky, Michael Gnant, Medical University of Vienna; Christian Fesl, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria; John Wayne Cowens, Sean Ferree, NanoString Technologies, Seattle, WA; and Carl Shaper, MyRAQA, Redwood Shores, CA.
Abstract
PURPOSE: We have previously shown that the PAM50-based risk of recurrence (ROR) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex, Tamoxifen Alone or in Combination (ATAC) trial (TransATAC) and Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG 8) randomized trials. Here, we focus on the ROR score for predicting distant recurrence after 5 years of follow-up in a combined analysis of these two randomized trials. METHODS: Long-term follow-up data and tissue samples were obtained from 2,137 postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG 8 and TransATAC trials. We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond 5 years in the combined data set. RESULTS: A total of 2,137 women who did not have a recurrence 5 years after diagnosis were included in the combined analyses. The Clinical Treatment Score (CTS) was the strongest prognostic factor 5 years after diagnosis (univariable: likelihood ratio [LR] χ(2) = 94.12, bivariable: LR χ(2) = 61.43). The ROR score was significantly prognostic by itself in years 5 to 10. In the node-negative/human epidermal growth factor receptor 2-negative subgroup, more prognostic value for late distant recurrence was added by the ROR score compared with the CTS. CONCLUSION: The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period. These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond 5 years of treatment.
RCT Entities:
PURPOSE: We have previously shown that the PAM50-based risk of recurrence (ROR) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex, Tamoxifen Alone or in Combination (ATAC) trial (TransATAC) and Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG 8) randomized trials. Here, we focus on the ROR score for predicting distant recurrence after 5 years of follow-up in a combined analysis of these two randomized trials. METHODS: Long-term follow-up data and tissue samples were obtained from 2,137 postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG 8 and TransATAC trials. We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond 5 years in the combined data set. RESULTS: A total of 2,137 women who did not have a recurrence 5 years after diagnosis were included in the combined analyses. The Clinical Treatment Score (CTS) was the strongest prognostic factor 5 years after diagnosis (univariable: likelihood ratio [LR] χ(2) = 94.12, bivariable: LR χ(2) = 61.43). The ROR score was significantly prognostic by itself in years 5 to 10. In the node-negative/humanepidermal growth factor receptor 2-negative subgroup, more prognostic value for late distant recurrence was added by the ROR score compared with the CTS. CONCLUSION: The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period. These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond 5 years of treatment.
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