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Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR)
BACKGROUND: The enhanced knowledge of cancer biology has led to considerable advancement in systemic therapy for advanced breast cancer. Recently, studies showed that cyclin-dependent kinase (CDK) 4/6 inhibitor, when added to endocrine therapy, had improved the outcomes of patients with advanced ER-...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989018/ https://www.ncbi.nlm.nih.gov/pubmed/33757458 http://dx.doi.org/10.1186/s12885-021-08042-w |
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author | Alomran, Reem White, Michelle Bruce, Melissa Bressel, Mathias Roache, Susan Karroum, Lama Hanna, Gerard G. Siva, Shankar Goel, Shom David, Steven |
author_facet | Alomran, Reem White, Michelle Bruce, Melissa Bressel, Mathias Roache, Susan Karroum, Lama Hanna, Gerard G. Siva, Shankar Goel, Shom David, Steven |
author_sort | Alomran, Reem |
collection | PubMed |
description | BACKGROUND: The enhanced knowledge of cancer biology has led to considerable advancement in systemic therapy for advanced breast cancer. Recently, studies showed that cyclin-dependent kinase (CDK) 4/6 inhibitor, when added to endocrine therapy, had improved the outcomes of patients with advanced ER-positive HER2-negative breast cancer. However, the disease often progresses following a period of treatment response. In a subset of patients, disease progression may occur at limited sites, i.e., oligoprogressive disease (OPD). In the past few years, stereotactic radiotherapy (SRT) has emerged as a safe and effective treatment for advanced cancer when delivered to limited metastatic sites. Hence, it is worth investigating the role of SRT in the setting of oligoprogressive breast cancer. METHOD: AVATAR is a multicentre phase II registry trial of SRT with endocrine therapy and CDK 4/6 inhibitor for the management of advanced ER-positive HER2-negative breast cancer. The study aims to enrol 32 patients with OPD limited to 5 lesions. The primary endpoint of the study is time to change systemic therapy measured from the commencement of SRT to change in systemic therapy. Secondary objectives include overall survival, progression free survival and treatment related toxicity. The exploratory objective is to describe the time to change in systemic therapy by the site (bone only vs. non-bone lesions) and number (1 vs. > 1) of OPD. DISCUSSION: This study aims to explore the effect of SRT in maximising the benefit of systemic therapy in patients with oligoprogressive ER-positive HER2-negative breast cancer. This approach might help reduce the burden of disease and improve the life quality in these patients. TRIAL REGISTRATION: ACTRN, ACTRN12620001212943. Date of registration 16 November 2020- Retrospectively registered. |
format | Online Article Text |
id | pubmed-7989018 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-79890182021-03-25 Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) Alomran, Reem White, Michelle Bruce, Melissa Bressel, Mathias Roache, Susan Karroum, Lama Hanna, Gerard G. Siva, Shankar Goel, Shom David, Steven BMC Cancer Study Protocol BACKGROUND: The enhanced knowledge of cancer biology has led to considerable advancement in systemic therapy for advanced breast cancer. Recently, studies showed that cyclin-dependent kinase (CDK) 4/6 inhibitor, when added to endocrine therapy, had improved the outcomes of patients with advanced ER-positive HER2-negative breast cancer. However, the disease often progresses following a period of treatment response. In a subset of patients, disease progression may occur at limited sites, i.e., oligoprogressive disease (OPD). In the past few years, stereotactic radiotherapy (SRT) has emerged as a safe and effective treatment for advanced cancer when delivered to limited metastatic sites. Hence, it is worth investigating the role of SRT in the setting of oligoprogressive breast cancer. METHOD: AVATAR is a multicentre phase II registry trial of SRT with endocrine therapy and CDK 4/6 inhibitor for the management of advanced ER-positive HER2-negative breast cancer. The study aims to enrol 32 patients with OPD limited to 5 lesions. The primary endpoint of the study is time to change systemic therapy measured from the commencement of SRT to change in systemic therapy. Secondary objectives include overall survival, progression free survival and treatment related toxicity. The exploratory objective is to describe the time to change in systemic therapy by the site (bone only vs. non-bone lesions) and number (1 vs. > 1) of OPD. DISCUSSION: This study aims to explore the effect of SRT in maximising the benefit of systemic therapy in patients with oligoprogressive ER-positive HER2-negative breast cancer. This approach might help reduce the burden of disease and improve the life quality in these patients. TRIAL REGISTRATION: ACTRN, ACTRN12620001212943. Date of registration 16 November 2020- Retrospectively registered. BioMed Central 2021-03-23 /pmc/articles/PMC7989018/ /pubmed/33757458 http://dx.doi.org/10.1186/s12885-021-08042-w Text en © The Author(s) 2021 Open AccessThis 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 licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence 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 licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Alomran, Reem White, Michelle Bruce, Melissa Bressel, Mathias Roache, Susan Karroum, Lama Hanna, Gerard G. Siva, Shankar Goel, Shom David, Steven Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title | Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title_full | Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title_fullStr | Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title_full_unstemmed | Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title_short | Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR) |
title_sort | stereotactic radiotherapy for oligoprogressive er-positive breast cancer (avatar) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989018/ https://www.ncbi.nlm.nih.gov/pubmed/33757458 http://dx.doi.org/10.1186/s12885-021-08042-w |
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