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Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma
Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This realworld, multicenter, observational, non-interventional study of bortezomib was designed to collect and analyze prospective data in Taiwanese patients with relapsed or refractory MM...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
PAGEPress Publications, Pavia, Italy
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379781/ https://www.ncbi.nlm.nih.gov/pubmed/30858932 http://dx.doi.org/10.4081/oncol.2019.377 |
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author | Huang, Shang-Yi Chen, Tsai-Yun Kuo, Ching-Yuan Chen, Yeu-Chin Lin, Sheng-Fung Chang, Ming-Chih Lv, Xinzhu Yang, Betty Chang, Cheng-Shyong |
author_facet | Huang, Shang-Yi Chen, Tsai-Yun Kuo, Ching-Yuan Chen, Yeu-Chin Lin, Sheng-Fung Chang, Ming-Chih Lv, Xinzhu Yang, Betty Chang, Cheng-Shyong |
author_sort | Huang, Shang-Yi |
collection | PubMed |
description | Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This realworld, multicenter, observational, non-interventional study of bortezomib was designed to collect and analyze prospective data in Taiwanese patients with relapsed or refractory MM. The primary endpoints included clinical effectiveness outcomes (disease response, disease progression [PD], time-to-response, time-toprogression, response duration, and overall survival [OS]). Secondary endpoints were safety and healthcare resource utilization. Total 100 patients (median [range] age 64.9 [37.0-85.5] years) were enrolled; 47 patients completed the study. Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up. Four patients in Cycle 1, 6 patients each in Cycle 2 and 5, 7 in Cycle 3, 10 patients in Cycle 4, 5 patients in Cycle 6, and 3 patients each in Cycle 7 and 8 achieved overall response during the study. Time-to-response was 4.68 months (95%CI: 3.2, NE) and response duration was 10.08 months (95%CI: 2.3, 28.6). Median OS was 9.8 months (95%CI: 3.8, 13.7), and median time-to-progression was 11.3 months (95%CI: 6.2, 20.2). Most common non-hematological AEs were diarrhea (n=32) and hypoesthesia (n=25); most common hematological AE was thrombocytopenia (n=18). Efficacy and safety profile of bortezomib in Taiwanese patients with MM was similar to global and other Asian population. Study provides a critical insight on use of bortezomib in realworld clinical practice, which can be helpful for Taiwanese healthcare providers’ decision-making processes. |
format | Online Article Text |
id | pubmed-6379781 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | PAGEPress Publications, Pavia, Italy |
record_format | MEDLINE/PubMed |
spelling | pubmed-63797812019-03-11 Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma Huang, Shang-Yi Chen, Tsai-Yun Kuo, Ching-Yuan Chen, Yeu-Chin Lin, Sheng-Fung Chang, Ming-Chih Lv, Xinzhu Yang, Betty Chang, Cheng-Shyong Oncol Rev Review Bortezomib is a proteasome inhibitor, approved for treating newly diagnosed and relapsed multiple myeloma (MM). This realworld, multicenter, observational, non-interventional study of bortezomib was designed to collect and analyze prospective data in Taiwanese patients with relapsed or refractory MM. The primary endpoints included clinical effectiveness outcomes (disease response, disease progression [PD], time-to-response, time-toprogression, response duration, and overall survival [OS]). Secondary endpoints were safety and healthcare resource utilization. Total 100 patients (median [range] age 64.9 [37.0-85.5] years) were enrolled; 47 patients completed the study. Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up. Four patients in Cycle 1, 6 patients each in Cycle 2 and 5, 7 in Cycle 3, 10 patients in Cycle 4, 5 patients in Cycle 6, and 3 patients each in Cycle 7 and 8 achieved overall response during the study. Time-to-response was 4.68 months (95%CI: 3.2, NE) and response duration was 10.08 months (95%CI: 2.3, 28.6). Median OS was 9.8 months (95%CI: 3.8, 13.7), and median time-to-progression was 11.3 months (95%CI: 6.2, 20.2). Most common non-hematological AEs were diarrhea (n=32) and hypoesthesia (n=25); most common hematological AE was thrombocytopenia (n=18). Efficacy and safety profile of bortezomib in Taiwanese patients with MM was similar to global and other Asian population. Study provides a critical insight on use of bortezomib in realworld clinical practice, which can be helpful for Taiwanese healthcare providers’ decision-making processes. PAGEPress Publications, Pavia, Italy 2019-01-18 /pmc/articles/PMC6379781/ /pubmed/30858932 http://dx.doi.org/10.4081/oncol.2019.377 Text en ©Copyright S-Y. Huang et al., 2019 http://creativecommons.org/licenses/by-nc/4.0/ This work is licensed under a Creative Commons Attribution NonCommercial 4.0 License (CC BY-NC 4.0). |
spellingShingle | Review Huang, Shang-Yi Chen, Tsai-Yun Kuo, Ching-Yuan Chen, Yeu-Chin Lin, Sheng-Fung Chang, Ming-Chih Lv, Xinzhu Yang, Betty Chang, Cheng-Shyong Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title_full | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title_fullStr | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title_full_unstemmed | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title_short | Bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
title_sort | bortezomib therapy in a real-world setting in patients with relapsed or refractory multiple myeloma |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379781/ https://www.ncbi.nlm.nih.gov/pubmed/30858932 http://dx.doi.org/10.4081/oncol.2019.377 |
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