Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)

Lynne I. Wagner; Fengmin Zhao; Paul E. Goss; Judith Anne W. Chapman; Lois E. Shepherd; Timothy J. Whelan; Bassam I. Mattar; Jose A. Bufill; William C. Schultz; Irving E. LaFrancis; Gauri G. Nagargoje; Radhakrishna Vemuri; Daniel A. Nikcevich; George W. Sledge; David Cella

doi:10.1007/s10549-018-4713-2

Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)

Lynne I. Wagner^*, Fengmin Zhao, Paul E. Goss, Judith Anne W. Chapman, Lois E. Shepherd, Timothy J. Whelan, Bassam I. Mattar, Jose A. Bufill, William C. Schultz, Irving E. LaFrancis, Gauri G. Nagargoje, Radhakrishna Vemuri, Daniel A. Nikcevich, George W. Sledge, David Cella

^*Corresponding author for this work

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Abstract

Purpose: Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized to anastrozole or exemestane. Methods: MA.27 participants (N = 686, of 7576) randomized to 5 years of anastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. Results: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08–1.55, p = 0.01). Conclusions: TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.

Original language	English (US)
Pages (from-to)	537-548
Number of pages	12
Journal	Breast Cancer Research and Treatment
Volume	169
Issue number	3
DOIs	https://doi.org/10.1007/s10549-018-4713-2
State	Published - Jun 1 2018

Funding

Acknowledgements This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. All authors state that they have no conflicts of interest.

Keywords

Endocrine therapy adherence
Patient-reported outcomes
Quality of life
Tolerability
Treatment-related symptoms

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Wagner, L. I., Zhao, F., Goss, P. E., Chapman, J. A. W., Shepherd, L. E., Whelan, T. J., Mattar, B. I., Bufill, J. A., Schultz, W. C., LaFrancis, I. E., Nagargoje, G. G., Vemuri, R., Nikcevich, D. A., Sledge, G. W., & Cella, D. (2018). Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). Breast Cancer Research and Treatment, 169(3), 537-548. https://doi.org/10.1007/s10549-018-4713-2

Wagner, Lynne I. ; Zhao, Fengmin ; Goss, Paul E. et al. / Patient-reported predictors of early treatment discontinuation : treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). In: Breast Cancer Research and Treatment. 2018 ; Vol. 169, No. 3. pp. 537-548.

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title = "Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)",

abstract = "Purpose: Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized to anastrozole or exemestane. Methods: MA.27 participants (N = 686, of 7576) randomized to 5 years of anastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. Results: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08–1.55, p = 0.01). Conclusions: TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.",

keywords = "Endocrine therapy adherence, Patient-reported outcomes, Quality of life, Tolerability, Treatment-related symptoms",

author = "Wagner, {Lynne I.} and Fengmin Zhao and Goss, {Paul E.} and Chapman, {Judith Anne W.} and Shepherd, {Lois E.} and Whelan, {Timothy J.} and Mattar, {Bassam I.} and Bufill, {Jose A.} and Schultz, {William C.} and LaFrancis, {Irving E.} and Nagargoje, {Gauri G.} and Radhakrishna Vemuri and Nikcevich, {Daniel A.} and Sledge, {George W.} and David Cella",

note = "Funding Information: Acknowledgements This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. Funding Information: This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. All authors state that they have no conflicts of interest. Publisher Copyright: {\textcopyright} 2018, Springer Science+Business Media, LLC, part of Springer Nature.",

year = "2018",

month = jun,

day = "1",

doi = "10.1007/s10549-018-4713-2",

language = "English (US)",

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Wagner, LI, Zhao, F, Goss, PE, Chapman, JAW, Shepherd, LE, Whelan, TJ, Mattar, BI, Bufill, JA, Schultz, WC, LaFrancis, IE, Nagargoje, GG, Vemuri, R, Nikcevich, DA, Sledge, GW & Cella, D 2018, 'Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)', Breast Cancer Research and Treatment, vol. 169, no. 3, pp. 537-548. https://doi.org/10.1007/s10549-018-4713-2

Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). / Wagner, Lynne I.; Zhao, Fengmin; Goss, Paul E. et al.
In: Breast Cancer Research and Treatment, Vol. 169, No. 3, 01.06.2018, p. 537-548.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Patient-reported predictors of early treatment discontinuation

T2 - treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)

AU - Wagner, Lynne I.

AU - Zhao, Fengmin

AU - Goss, Paul E.

AU - Chapman, Judith Anne W.

AU - Shepherd, Lois E.

AU - Whelan, Timothy J.

AU - Mattar, Bassam I.

AU - Bufill, Jose A.

AU - Schultz, William C.

AU - LaFrancis, Irving E.

AU - Nagargoje, Gauri G.

AU - Vemuri, Radhakrishna

AU - Nikcevich, Daniel A.

AU - Sledge, George W.

AU - Cella, David

N1 - Funding Information: Acknowledgements This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. Funding Information: This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following Award Numbers: CA189828, CA180867, CA189808, CA189954, CA180799, CA189822, CA189863, CA189860, CA189812, CA180816, CA180795, CA180863, Canadian Cancer Society Research Institute Grants #021039 and #704970 and by the AVON Breast Cancer Crusade ABCC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. All authors state that they have no conflicts of interest. Publisher Copyright: © 2018, Springer Science+Business Media, LLC, part of Springer Nature.

PY - 2018/6/1

Y1 - 2018/6/1

N2 - Purpose: Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized to anastrozole or exemestane. Methods: MA.27 participants (N = 686, of 7576) randomized to 5 years of anastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. Results: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08–1.55, p = 0.01). Conclusions: TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.

AB - Purpose: Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized to anastrozole or exemestane. Methods: MA.27 participants (N = 686, of 7576) randomized to 5 years of anastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. Results: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08–1.55, p = 0.01). Conclusions: TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.

KW - Endocrine therapy adherence

KW - Patient-reported outcomes

KW - Quality of life

KW - Tolerability

KW - Treatment-related symptoms

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DO - 10.1007/s10549-018-4713-2

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JF - Breast Cancer Research and Treatment

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Wagner LI, Zhao F, Goss PE, Chapman JAW, Shepherd LE, Whelan TJ et al. Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). Breast Cancer Research and Treatment. 2018 Jun 1;169(3):537-548. doi: 10.1007/s10549-018-4713-2

Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03)

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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