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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2014
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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. |
format | Online Article Text |
id | pubmed-4209095 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
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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