Journal article

Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT

Olivia Pagani, Prudence A Francis, Gini F Fleming, Barbara A Walley, Giuseppe Viale, Marco Colleoni, Istvan Lang, Henry L Gomez, Carlo Tondini, Graziella Pinotti, Angelo Di Leo, Alan S Coates, Aron Goldhirsch, Richard D Gelber, Meredith M Regan

JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2020

Abstract

PURPOSE: The Tamoxifen and Exemestane Trial (TEXT)/Suppression of Ovarian Function Trial (SOFT) showed superior outcomes for premenopausal women with hormone receptor (HR)-positive breast cancer treated with adjuvant exemestane plus ovarian function suppression (OFS) or tamoxifen plus OFS versus tamoxifen alone. We previously reported the magnitude of absolute improvements in freedom from any recurrence across a continuous, composite measure of recurrence risk to tailor decision making. With longer follow-up, we now focus on distant recurrence. METHODS: The TEXT/SOFT HR-positive/human epidermal growth factor receptor 2 (HER2)-negative analysis population included 4,891 women stratified by pr..

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Grants

Awarded by Breast Cancer Research Foundation


Awarded by Susan G. Komen for the Cure Promise


Awarded by US National Cancer Institute


Awarded by Breast Cancer Trials Australia & New Zealand (National Health and Medical Research Council)


Awarded by Institute of Cancer Research Clinical Trials and Statistics Unit on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom (Cancer Research UK)


Awarded by Institute of Cancer Research Clinical Trials and Statistics Unit on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom (National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical


Awarded by Alliance for Clinical Trials in Oncology (US National Institutes of Health [NIH])


Awarded by SWOG (US NIH grant)


Awarded by Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (US NI)


Awarded by NRG Oncology (US NIH)


Awarded by Canadian Cancer Trials Group (US NIH)


Awarded by Canadian Cancer Trials Group (Canadian Cancer Society Research Institute grants)


Funding Acknowledgements

Supported by Pfizer, the International Breast Cancer Study Group, the US National Cancer Institute, and the Breast Cancer Research Foundation (16-185, 17-187, and 18-003) for Tamoxifen and Exemestane Trial and Suppression of Ovarian Function Trial conduct. Pfizer and Ipsen provided the drug supply. Support for central pathology included Susan G. Komen for the Cure Promise Grant KG080081 and the Breast Cancer Research Foundation. Support for the coordinating group, International Breast Cancer Study Group, was from the US National Cancer Institute (CA075362), Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research, Cancer Research Switzerland, Oncosuisse, Cancer League Switzerland, Foundation for Clinical Cancer Research of Eastern Switzerland. Support of cooperative groups was as follows: Breast Cancer Trials Australia & New Zealand (National Health and Medical Research Council grants 351161, 510788, and 1105058); Institute of Cancer Research Clinical Trials and Statistics Unit on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom (Cancer Research UK grants CRUKE/03/022 and CRUKE/03/023 and grant A15955 National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical Research Centre, National Institute for Health Research/Cambridge Biomedical Research Centre); Alliance for Clinical Trials in Oncology (US National Institutes of Health [NIH] grant CA180821); SWOG (US NIH grant CA32102); Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (US NIH grants CA21115 and CA16116); NRG Oncology (US NIH grants U10CA180868, U10CA180822, and UG1CA189867); and Canadian Cancer Trials Group (US NIH grant CA077202 and Canadian Cancer Society Research Institute grants 015469 and 021039).