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Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation
Many patients discontinue endocrine therapy for breast cancer due to intolerance. Identification of patients at risk for discontinuation is challenging. The minimal important difference (MID) is the smallest change in a score on a patient-reported outcome (PRO) that is clinically significant. We eva...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9023490/ https://www.ncbi.nlm.nih.gov/pubmed/35449210 http://dx.doi.org/10.1038/s41523-022-00414-0 |
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author | Smith, Karen Lisa Verma, Neha Blackford, Amanda L. Lehman, Jennifer Westbrook, Kelly Lim, David Fetting, John Wolff, Antonio C. Jelovac, Daniela Miller, Robert S. Connolly, Roisin Armstrong, Deborah K. Nunes, Raquel Visvanathan, Kala Riley, Carol Papathakis, Katie Zafman, Nelli Sheng, Jennifer Y. Snyder, Claire Stearns, Vered |
author_facet | Smith, Karen Lisa Verma, Neha Blackford, Amanda L. Lehman, Jennifer Westbrook, Kelly Lim, David Fetting, John Wolff, Antonio C. Jelovac, Daniela Miller, Robert S. Connolly, Roisin Armstrong, Deborah K. Nunes, Raquel Visvanathan, Kala Riley, Carol Papathakis, Katie Zafman, Nelli Sheng, Jennifer Y. Snyder, Claire Stearns, Vered |
author_sort | Smith, Karen Lisa |
collection | PubMed |
description | Many patients discontinue endocrine therapy for breast cancer due to intolerance. Identification of patients at risk for discontinuation is challenging. The minimal important difference (MID) is the smallest change in a score on a patient-reported outcome (PRO) that is clinically significant. We evaluated the association between treatment-emergent symptoms detected by worsening PRO scores in units equal to the MID with discontinuation. We enrolled females with stage 0-III breast cancer initiating endocrine therapy in a prospective cohort. Participants completed PROs at baseline, 3, 6, 12, 24, 36, 48, and 60 months. Measures included PROMIS pain interference, fatigue, depression, anxiety, physical function, and sleep disturbance; Endocrine Subscale of the FACT-ES; and MOS-Sexual Problems (MOS-SP). We evaluated associations between continuous PRO scores in units corresponding to MIDs (PROMIS: 4-points; FACT-ES: 5-points; MOS-SP: 8-points) with time to endocrine therapy discontinuation using Cox proportional hazards models. Among 321 participants, 140 (43.6%) initiated tamoxifen and 181 (56.4%) initiated aromatase inhibitor (AI). The cumulative probability of discontinuation was 23% (95% CI 18–27%) at 48 months. For every 5- and 4-point worsening in endocrine symptoms and sleep disturbance respectively, participants were 13 and 14% more likely to discontinue endocrine therapy respectively (endocrine symptoms HR 1.13, 95% CI 1.02–1.25, p = 0.02; sleep disturbance HR 1.14, 95% CI 1.01–1.29, p = 0.03). AI treatment was associated with greater likelihood of discontinuation than tamoxifen. Treatment-emergent endocrine symptoms and sleep disturbance are associated with endocrine therapy discontinuation. Monitoring for worsening scores meeting or exceeding the MID on PROs may identify patients at risk for discontinuation. |
format | Online Article Text |
id | pubmed-9023490 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-90234902022-04-28 Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation Smith, Karen Lisa Verma, Neha Blackford, Amanda L. Lehman, Jennifer Westbrook, Kelly Lim, David Fetting, John Wolff, Antonio C. Jelovac, Daniela Miller, Robert S. Connolly, Roisin Armstrong, Deborah K. Nunes, Raquel Visvanathan, Kala Riley, Carol Papathakis, Katie Zafman, Nelli Sheng, Jennifer Y. Snyder, Claire Stearns, Vered NPJ Breast Cancer Article Many patients discontinue endocrine therapy for breast cancer due to intolerance. Identification of patients at risk for discontinuation is challenging. The minimal important difference (MID) is the smallest change in a score on a patient-reported outcome (PRO) that is clinically significant. We evaluated the association between treatment-emergent symptoms detected by worsening PRO scores in units equal to the MID with discontinuation. We enrolled females with stage 0-III breast cancer initiating endocrine therapy in a prospective cohort. Participants completed PROs at baseline, 3, 6, 12, 24, 36, 48, and 60 months. Measures included PROMIS pain interference, fatigue, depression, anxiety, physical function, and sleep disturbance; Endocrine Subscale of the FACT-ES; and MOS-Sexual Problems (MOS-SP). We evaluated associations between continuous PRO scores in units corresponding to MIDs (PROMIS: 4-points; FACT-ES: 5-points; MOS-SP: 8-points) with time to endocrine therapy discontinuation using Cox proportional hazards models. Among 321 participants, 140 (43.6%) initiated tamoxifen and 181 (56.4%) initiated aromatase inhibitor (AI). The cumulative probability of discontinuation was 23% (95% CI 18–27%) at 48 months. For every 5- and 4-point worsening in endocrine symptoms and sleep disturbance respectively, participants were 13 and 14% more likely to discontinue endocrine therapy respectively (endocrine symptoms HR 1.13, 95% CI 1.02–1.25, p = 0.02; sleep disturbance HR 1.14, 95% CI 1.01–1.29, p = 0.03). AI treatment was associated with greater likelihood of discontinuation than tamoxifen. Treatment-emergent endocrine symptoms and sleep disturbance are associated with endocrine therapy discontinuation. Monitoring for worsening scores meeting or exceeding the MID on PROs may identify patients at risk for discontinuation. Nature Publishing Group UK 2022-04-21 /pmc/articles/PMC9023490/ /pubmed/35449210 http://dx.doi.org/10.1038/s41523-022-00414-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Smith, Karen Lisa Verma, Neha Blackford, Amanda L. Lehman, Jennifer Westbrook, Kelly Lim, David Fetting, John Wolff, Antonio C. Jelovac, Daniela Miller, Robert S. Connolly, Roisin Armstrong, Deborah K. Nunes, Raquel Visvanathan, Kala Riley, Carol Papathakis, Katie Zafman, Nelli Sheng, Jennifer Y. Snyder, Claire Stearns, Vered Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title | Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title_full | Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title_fullStr | Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title_full_unstemmed | Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title_short | Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
title_sort | association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9023490/ https://www.ncbi.nlm.nih.gov/pubmed/35449210 http://dx.doi.org/10.1038/s41523-022-00414-0 |
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