Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials

Poornima Saha, Meredith M. Regan, Olivia Pagani, Prudence A. Francis, Barbara A. Walley, Karin Ribi, Jürg Bernhard, Weixiu Luo, Henry L. Gómez, Harold J. Burstein, Vani Parmar, Roberto Torres, Josephine Stewart, Meritxell Bellet, Antonia Perelló, Faysal Dane, Antonio Moreira, Daniel Vorobiof, Michelle Nottage, Karen N. PriceAlan S. Coates, Aron Goldhirsch, Richard D. Gelber, Marco Colleoni, Gini F. Fleming, SOFT and TEXT Investigators and International Breast Cancer Study Group

Research output: Contribution to journalArticle

Abstract

Purpose: To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods: In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results: For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion: In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.

Original languageEnglish
Pages (from-to)3113-3122
Number of pages10
JournalJournal of Clinical Oncology
Volume35
Issue number27
DOIs
Publication statusPublished - Sep 20 2017

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exemestane
Tamoxifen
Quality of Life
Breast Neoplasms
Therapeutics
Drug Therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Saha, P., Regan, M. M., Pagani, O., Francis, P. A., Walley, B. A., Ribi, K., ... SOFT and TEXT Investigators and International Breast Cancer Study Group (2017). Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials. Journal of Clinical Oncology, 35(27), 3113-3122. https://doi.org/10.1200/JCO.2016.72.0946

Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials. / Saha, Poornima; Regan, Meredith M.; Pagani, Olivia; Francis, Prudence A.; Walley, Barbara A.; Ribi, Karin; Bernhard, Jürg; Luo, Weixiu; Gómez, Henry L.; Burstein, Harold J.; Parmar, Vani; Torres, Roberto; Stewart, Josephine; Bellet, Meritxell; Perelló, Antonia; Dane, Faysal; Moreira, Antonio; Vorobiof, Daniel; Nottage, Michelle; Price, Karen N.; Coates, Alan S.; Goldhirsch, Aron; Gelber, Richard D.; Colleoni, Marco; Fleming, Gini F.; SOFT and TEXT Investigators and International Breast Cancer Study Group.

In: Journal of Clinical Oncology, Vol. 35, No. 27, 20.09.2017, p. 3113-3122.

Research output: Contribution to journalArticle

Saha, P, Regan, MM, Pagani, O, Francis, PA, Walley, BA, Ribi, K, Bernhard, J, Luo, W, Gómez, HL, Burstein, HJ, Parmar, V, Torres, R, Stewart, J, Bellet, M, Perelló, A, Dane, F, Moreira, A, Vorobiof, D, Nottage, M, Price, KN, Coates, AS, Goldhirsch, A, Gelber, RD, Colleoni, M, Fleming, GF & SOFT and TEXT Investigators and International Breast Cancer Study Group 2017, 'Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials', Journal of Clinical Oncology, vol. 35, no. 27, pp. 3113-3122. https://doi.org/10.1200/JCO.2016.72.0946
Saha, Poornima ; Regan, Meredith M. ; Pagani, Olivia ; Francis, Prudence A. ; Walley, Barbara A. ; Ribi, Karin ; Bernhard, Jürg ; Luo, Weixiu ; Gómez, Henry L. ; Burstein, Harold J. ; Parmar, Vani ; Torres, Roberto ; Stewart, Josephine ; Bellet, Meritxell ; Perelló, Antonia ; Dane, Faysal ; Moreira, Antonio ; Vorobiof, Daniel ; Nottage, Michelle ; Price, Karen N. ; Coates, Alan S. ; Goldhirsch, Aron ; Gelber, Richard D. ; Colleoni, Marco ; Fleming, Gini F. ; SOFT and TEXT Investigators and International Breast Cancer Study Group. / Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 27. pp. 3113-3122.
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abstract = "Purpose: To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods: In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results: For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1{\%} (95{\%} CI, 54.6{\%} to 76.9{\%}) with tamoxifen alone, 75.9{\%} with tamoxifen plus OFS (95{\%} CI, 64.0{\%} to 84.4{\%}), and 83.2{\%} with exemestane plus OFS (95{\%} CI, 72.7{\%} to 90.0{\%}). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2{\%} (95{\%} CI, 66.2{\%} to 87.7{\%}) with tamoxifen plus OFS and 81.6{\%} (95{\%} CI, 69.8{\%} to 89.2{\%}) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8{\%} of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion: In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.",
author = "Poornima Saha and Regan, {Meredith M.} and Olivia Pagani and Francis, {Prudence A.} and Walley, {Barbara A.} and Karin Ribi and J{\"u}rg Bernhard and Weixiu Luo and G{\'o}mez, {Henry L.} and Burstein, {Harold J.} and Vani Parmar and Roberto Torres and Josephine Stewart and Meritxell Bellet and Antonia Perell{\'o} and Faysal Dane and Antonio Moreira and Daniel Vorobiof and Michelle Nottage and Price, {Karen N.} and Coates, {Alan S.} and Aron Goldhirsch and Gelber, {Richard D.} and Marco Colleoni and Fleming, {Gini F.} and {SOFT and TEXT Investigators and International Breast Cancer Study Group}",
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TY - JOUR

T1 - Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials

AU - Saha, Poornima

AU - Regan, Meredith M.

AU - Pagani, Olivia

AU - Francis, Prudence A.

AU - Walley, Barbara A.

AU - Ribi, Karin

AU - Bernhard, Jürg

AU - Luo, Weixiu

AU - Gómez, Henry L.

AU - Burstein, Harold J.

AU - Parmar, Vani

AU - Torres, Roberto

AU - Stewart, Josephine

AU - Bellet, Meritxell

AU - Perelló, Antonia

AU - Dane, Faysal

AU - Moreira, Antonio

AU - Vorobiof, Daniel

AU - Nottage, Michelle

AU - Price, Karen N.

AU - Coates, Alan S.

AU - Goldhirsch, Aron

AU - Gelber, Richard D.

AU - Colleoni, Marco

AU - Fleming, Gini F.

AU - SOFT and TEXT Investigators and International Breast Cancer Study Group

PY - 2017/9/20

Y1 - 2017/9/20

N2 - Purpose: To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods: In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results: For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion: In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.

AB - Purpose: To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods: In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results: For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion: In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.

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