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Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer
BACKGROUND: We present the 2-year results of a randomised trial comparing 4- versus 12-weekly bone-targeting agents (BTAs) in patients with bone metastases from breast or castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: Patients with bone metastases from breast or CRPC, who were go...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449269/ https://www.ncbi.nlm.nih.gov/pubmed/34567960 http://dx.doi.org/10.1016/j.jbo.2021.100388 |
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author | Clemons, Mark Liu, Michelle Stober, Carol Pond, Gregory Jemaan Alzahrani, Mashari Ong, Michael Ernst, Scott Booth, Christopher Mates, Mihaela Abraham Joy, Anil Aseyev, Olexiy Blanchette, Phillip Vandermeer, Lisa Tu, Megan Thavorn, Kednapa Fergusson, Dean |
author_facet | Clemons, Mark Liu, Michelle Stober, Carol Pond, Gregory Jemaan Alzahrani, Mashari Ong, Michael Ernst, Scott Booth, Christopher Mates, Mihaela Abraham Joy, Anil Aseyev, Olexiy Blanchette, Phillip Vandermeer, Lisa Tu, Megan Thavorn, Kednapa Fergusson, Dean |
author_sort | Clemons, Mark |
collection | PubMed |
description | BACKGROUND: We present the 2-year results of a randomised trial comparing 4- versus 12-weekly bone-targeting agents (BTAs) in patients with bone metastases from breast or castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: Patients with bone metastases from breast or CRPC, who were going to start or were already receiving BTAs, were randomised to 4- or 12-weekly BTA treatment for 2 years. The endpoints were: symptomatic skeletal events (SSE) rates, time to SSEs, toxicity and cost-effectiveness. RESULTS: Of 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). After 2 years, the cumulative incidence rate (95% CI) of SSEs was 32.7% (24.6% to 41.1%) and 28.1% (20.3% to 36.4%) for the 4- and 12-weekly intervention groups respectively. The hazard ratio for time to first SSE was 0.96 (95% CI = 0.63 to 1.47). However, in a post hoc analysis, those patients who had an on-study SSE, there was a small non-statistical increased risk of subsequent SSEs among patients on the 12-weekly dosing arm (HR = 1.14; 95% CI – 0.90–1.44). BTA-related toxicity rates were similar between study arms. A cost-utility analysis showed that 12-weekly BTA is cost-effective from a public payer’s perspective. CONCLUSION: These results in addition to those previously reported for de-escalating zoledronate, would support that de-escalation of commonly used BTAs is a reasonable and economically valid treatment option. While not statistically significant, the increase in subsequent SSEs in the 12-weekly arm requires further exploration. |
format | Online Article Text |
id | pubmed-8449269 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-84492692021-09-24 Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer Clemons, Mark Liu, Michelle Stober, Carol Pond, Gregory Jemaan Alzahrani, Mashari Ong, Michael Ernst, Scott Booth, Christopher Mates, Mihaela Abraham Joy, Anil Aseyev, Olexiy Blanchette, Phillip Vandermeer, Lisa Tu, Megan Thavorn, Kednapa Fergusson, Dean J Bone Oncol Research Paper BACKGROUND: We present the 2-year results of a randomised trial comparing 4- versus 12-weekly bone-targeting agents (BTAs) in patients with bone metastases from breast or castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: Patients with bone metastases from breast or CRPC, who were going to start or were already receiving BTAs, were randomised to 4- or 12-weekly BTA treatment for 2 years. The endpoints were: symptomatic skeletal events (SSE) rates, time to SSEs, toxicity and cost-effectiveness. RESULTS: Of 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). After 2 years, the cumulative incidence rate (95% CI) of SSEs was 32.7% (24.6% to 41.1%) and 28.1% (20.3% to 36.4%) for the 4- and 12-weekly intervention groups respectively. The hazard ratio for time to first SSE was 0.96 (95% CI = 0.63 to 1.47). However, in a post hoc analysis, those patients who had an on-study SSE, there was a small non-statistical increased risk of subsequent SSEs among patients on the 12-weekly dosing arm (HR = 1.14; 95% CI – 0.90–1.44). BTA-related toxicity rates were similar between study arms. A cost-utility analysis showed that 12-weekly BTA is cost-effective from a public payer’s perspective. CONCLUSION: These results in addition to those previously reported for de-escalating zoledronate, would support that de-escalation of commonly used BTAs is a reasonable and economically valid treatment option. While not statistically significant, the increase in subsequent SSEs in the 12-weekly arm requires further exploration. Elsevier 2021-09-02 /pmc/articles/PMC8449269/ /pubmed/34567960 http://dx.doi.org/10.1016/j.jbo.2021.100388 Text en © 2021 Published by Elsevier GmbH. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Research Paper Clemons, Mark Liu, Michelle Stober, Carol Pond, Gregory Jemaan Alzahrani, Mashari Ong, Michael Ernst, Scott Booth, Christopher Mates, Mihaela Abraham Joy, Anil Aseyev, Olexiy Blanchette, Phillip Vandermeer, Lisa Tu, Megan Thavorn, Kednapa Fergusson, Dean Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title | Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title_full | Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title_fullStr | Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title_full_unstemmed | Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title_short | Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
title_sort | two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449269/ https://www.ncbi.nlm.nih.gov/pubmed/34567960 http://dx.doi.org/10.1016/j.jbo.2021.100388 |
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