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

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

  • Pagani, Olivia Institute of Oncology of Southern Switzerland, Geneva University Hospitals, and Swiss Group for Clinical Cancer Research (SAKK), Lugano Viganello, Switzerland
  • Francis, Prudence A. Peter MacCallum Cancer Center, St Vincent’s Hospital, and University of Melbourne, Melbourne, Victoria, Australia
  • Fleming, Gini F. The University of Chicago Medical Center, Chicago, IL
  • Walley, Barbara A. University of Calgary and Canadian Cancer Trials Group, Calgary, Alberta, Canada
  • Viale, Giuseppe International Breast Cancer Study Group Central Pathology Center, IEO, European Institute of Oncology IRCCS, and University of Milan, Milan, Italy
  • Colleoni, Marco IEO, European Institute of Oncology IRCCS and International Breast Cancer Study Group, Milan, Italy
  • Láng, István National Institute of Oncology, Budapest, Hungary
  • Gómez, Henry L. Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru
  • Tondini, Carlo Ospedale Papa Giovanni XXIII, Bergamo, Italy
  • Pinotti, Graziella ASST Settelaghi Ospedale di Circolo e Fondazione Macchi, Varese, Italy
  • Di Leo, Angelo Hospital of Prato-AUSL Toscana Centro and International Breast Cancer Study Group, Prato, Italy
  • Coates, Alan S. International Breast Cancer Study Group and University of Sydney, New South Wales, Australia
  • Goldhirsch, Aron IEO, European Institute of Oncology IRCCS and International Breast Cancer Study Group, Milan, Italy
  • Gelber, Richard D. International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA
  • Regan, Meredith M. International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA
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Published in:
  • Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2020, vol. 38, no. 12, p. 1293-1303
Cancer Research
Oncology
English 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 predetermined chemotherapy use. Kaplan-Meier estimates of 8-year freedom from distant recurrence were analyzed using subpopulation treatment effect pattern plot (STEPP) methodology across subpopulations defined by the continuous composite measure of recurrence risk. For each patient, the composite risk value was obtained from a Cox model that incorporated age; nodal status; tumor size; grade; and estrogen receptor, progesterone receptor, and Ki-67 labeling index expression levels. RESULTS The overall rate of 8-year freedom from distant recurrence was 91.1% and ranged from approximately 100% to 63% across lowest to highest composite risks. TEXT patients who received chemotherapy had an average absolute improvement with exemestane plus OFS versus tamoxifen plus OFS of 5.1%, and STEPP analysis showed improvements from less than 1% to more than 15% from lowest to highest composite risks. SOFT patients who remained premenopausal after chemotherapy had an average 5.2% absolute improvement with exemestane plus OFS versus tamoxifen and reached 10% across composite risks; for tamoxifen plus OFS versus tamoxifen, the maximum improvement was approximately 3.5%. Women who did not receive chemotherapy had a more than 97% rate of 8-year freedom from distant recurrence, and improvements with exemestane plus OFS ranged from 1% to 4%. CONCLUSION Premenopausal women with HR-positive/HER2-negative breast cancer and high recurrence risk, as defined by clinicopathologic characteristics, may experience a 10% to 15% absolute improvement in 8-year freedom from distant recurrence with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone. The potential benefit of escalating endocrine therapy versus tamoxifen alone is minimal for those at low recurrence risk.
Language
  • English
Open access status
hybrid
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Persistent URL
https://sonar.ch/global/documents/52989
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