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Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients

INTRODUCTION: Bortezomib, a novel proteasome inhibitor, is approved for the treatment of relapsed multiple myeloma (MM). Efficacy and safety of bortezomib is well known; however, it was necessary to validate the data in patients with different ethnic backgrounds. The efficacy and safety of bortezomi...

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Autores principales: Lin, MaoFang, Hou, Jian, Chen, WenMing, Huang, XiaoJun, Liu, ZhuoGang, Zhou, YuHong, Li, Yan, Zhao, Taiyun, Wang, LinNa, Wu, Kwang-Wei, Shen, ZhiXiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4209095/
https://www.ncbi.nlm.nih.gov/pubmed/25331616
http://dx.doi.org/10.1007/s12325-014-0159-z
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author Lin, MaoFang
Hou, Jian
Chen, WenMing
Huang, XiaoJun
Liu, ZhuoGang
Zhou, YuHong
Li, Yan
Zhao, Taiyun
Wang, LinNa
Wu, Kwang-Wei
Shen, ZhiXiang
author_facet Lin, MaoFang
Hou, Jian
Chen, WenMing
Huang, XiaoJun
Liu, ZhuoGang
Zhou, YuHong
Li, Yan
Zhao, Taiyun
Wang, LinNa
Wu, Kwang-Wei
Shen, ZhiXiang
author_sort Lin, MaoFang
collection PubMed
description INTRODUCTION: Bortezomib, a novel proteasome inhibitor, is approved for the treatment of relapsed multiple myeloma (MM). Efficacy and safety of bortezomib is well known; however, it was necessary to validate the data in patients with different ethnic backgrounds. The efficacy and safety of bortezomib was assessed in patients from China with relapsed/refractory MM in a real-world scenario. METHODS: This prospective, non-interventional, observational study enrolled both male and female Chinese patients, aged ≥18 years and diagnosed with relapsed or refractory MM. Administration of intravenous bortezomib at 1.3 mg/m(2) was recommended twice a week for 2 weeks (days 1, 4, 8 and 11), followed by a 10-day rest period (maximum of 8 cycles) and a follow-up every 12 weeks for 3 years. Efficacy assessments included best response, objective response rate (ORR), time to response, duration of response, and overall survival. Safety was also assessed. RESULTS: A total of 517 patients were enrolled with a median age of 58.7 years. Patients predominantly had immunoglobulin G type (46.2%) and stage III (47.8%) myeloma. Overall, 202 (42.3%) patients had partial response as best response, ORR was 88.9% and the proportion of patients exhibiting complete response was 24.7%. The median time to response observed was 27 (21–40) days. Median time to progression was 415 days and median overall survival was 475 days. Thrombocytopenia (14.4%) was the most common adverse event. CONCLUSION: Bortezomib demonstrated clinical response in majority of patients and was well tolerated in this observational study in Chinese patients with relapsed/refractory MM. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-014-0159-z) contains supplementary material, which is available to authorized users.
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spelling pubmed-42090952014-10-28 Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients Lin, MaoFang Hou, Jian Chen, WenMing Huang, XiaoJun Liu, ZhuoGang Zhou, YuHong Li, Yan Zhao, Taiyun Wang, LinNa Wu, Kwang-Wei Shen, ZhiXiang Adv Ther Original Research INTRODUCTION: Bortezomib, a novel proteasome inhibitor, is approved for the treatment of relapsed multiple myeloma (MM). Efficacy and safety of bortezomib is well known; however, it was necessary to validate the data in patients with different ethnic backgrounds. The efficacy and safety of bortezomib was assessed in patients from China with relapsed/refractory MM in a real-world scenario. METHODS: This prospective, non-interventional, observational study enrolled both male and female Chinese patients, aged ≥18 years and diagnosed with relapsed or refractory MM. Administration of intravenous bortezomib at 1.3 mg/m(2) was recommended twice a week for 2 weeks (days 1, 4, 8 and 11), followed by a 10-day rest period (maximum of 8 cycles) and a follow-up every 12 weeks for 3 years. Efficacy assessments included best response, objective response rate (ORR), time to response, duration of response, and overall survival. Safety was also assessed. RESULTS: A total of 517 patients were enrolled with a median age of 58.7 years. Patients predominantly had immunoglobulin G type (46.2%) and stage III (47.8%) myeloma. Overall, 202 (42.3%) patients had partial response as best response, ORR was 88.9% and the proportion of patients exhibiting complete response was 24.7%. The median time to response observed was 27 (21–40) days. Median time to progression was 415 days and median overall survival was 475 days. Thrombocytopenia (14.4%) was the most common adverse event. CONCLUSION: Bortezomib demonstrated clinical response in majority of patients and was well tolerated in this observational study in Chinese patients with relapsed/refractory MM. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-014-0159-z) contains supplementary material, which is available to authorized users. Springer Healthcare 2014-10-21 2014 /pmc/articles/PMC4209095/ /pubmed/25331616 http://dx.doi.org/10.1007/s12325-014-0159-z Text en © The Author(s) 2014 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Lin, MaoFang
Hou, Jian
Chen, WenMing
Huang, XiaoJun
Liu, ZhuoGang
Zhou, YuHong
Li, Yan
Zhao, Taiyun
Wang, LinNa
Wu, Kwang-Wei
Shen, ZhiXiang
Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title_full Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title_fullStr Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title_full_unstemmed Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title_short Improved Response Rates with Bortezomib in Relapsed or Refractory Multiple Myeloma: An Observational Study in Chinese Patients
title_sort improved response rates with bortezomib in relapsed or refractory multiple myeloma: an observational study in chinese patients
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4209095/
https://www.ncbi.nlm.nih.gov/pubmed/25331616
http://dx.doi.org/10.1007/s12325-014-0159-z
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