title: Improved response rates with bortezomib in relapsed or refractory multiple myeloma: an observational study in Chinese patients.
abstract: BACKGROUND
  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/m2 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.
  
  
  CONCLUSIONS
  Bortezomib demonstrated clinical response in majority of patients and was well tolerated in this observational study in Chinese patients with relapsed/refractory MM.
authors.affiliation: Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China.
authors.forename: MaoFang
authors.initials: M
authors.lastname: Lin
authors.forename: Jian
authors.initials: J
authors.lastname: Hou
authors.forename: WenMing
authors.initials: W
authors.lastname: Chen
authors.forename: XiaoJun
authors.initials: X
authors.lastname: Huang
authors.forename: ZhuoGang
authors.initials: Z
authors.lastname: Liu
authors.forename: YuHong
authors.initials: Y
authors.lastname: Zhou
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Taiyun
authors.initials: T
authors.lastname: Zhao
authors.forename: LinNa
authors.initials: L
authors.lastname: Wang
authors.forename: Kwang-Wei
authors.initials: KW
authors.lastname: Wu
authors.forename: ZhiXiang
authors.initials: Z
authors.lastname: Shen
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib / Q000008:administration & dosage / Q000009:adverse effects; D002681:China; D016903:Drug Monitoring; D004351:Drug Resistance; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000208:ethnology / Q000503:physiopathology; D009367:Neoplasm Staging; D011446:Prospective Studies; D061988:Proteasome Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D061988:Proteasome Inhibitors; D000069286:Bortezomib