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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: PAGEPress Publications, Pavia, Italy 2019
Materias:
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 Of the withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse events [AEs]-related: n=12, other reason: n=1), and 5 due to loss to follow-up.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.
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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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