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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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Detalles Bibliográficos
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
Descripción
Sumario: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.