PMID- 30858932
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1970-5565 (Print)
IS  - 1970-5557 (Electronic)
IS  - 1970-5557 (Linking)
VI  - 13
IP  - 1
DP  - 2019 Jan 14
TI  - Bortezomib therapy in a real-world setting in patients with relapsed or 
      refractory multiple myeloma.
PG  - 377
LID - 10.4081/oncol.2019.377 [doi]
LID - 377
AB  - 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      withdrawn patients (n=53), there were 48 deaths (PD-related death: n=35, adverse 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.
FAU - Huang, Shang-Yi
AU  - Huang SY
AD  - National Taiwan University Hospital, Taiwan.
FAU - Chen, Tsai-Yun
AU  - Chen TY
AD  - National Cheng Kung University Hospital, Taiwan.
FAU - Kuo, Ching-Yuan
AU  - Kuo CY
AD  - Kaohsiung Chang Gung Memorial Hospital, Taiwan.
FAU - Chen, Yeu-Chin
AU  - Chen YC
AD  - Tri-Service General Hospital, National Defense Medical Center, Taiwan.
FAU - Lin, Sheng-Fung
AU  - Lin SF
AD  - Kaohsiung Medical University Memorial Hospital.
FAU - Chang, Ming-Chih
AU  - Chang MC
AD  - Mackay Memorial Hospital, Taiwan.
FAU - Lv, Xinzhu
AU  - Lv X
AD  - Johnson & Johnson Investment Ltd, Shanghai, P.R. China.
FAU - Yang, Betty
AU  - Yang B
AD  - Janssen Medical Affairs, Taiwan.
FAU - Chang, Cheng-Shyong
AU  - Chang CS
AD  - Chang-Hua Christian Hospital, Taiwan.
LA  - eng
PT  - Journal Article
DEP - 20190118
PL  - Switzerland
TA  - Oncol Rev
JT  - Oncology reviews
JID - 101519906
PMC - PMC6379781
OTO - NOTNLM
OT  - Bortezomib
OT  - effectiveness
OT  - multiple myeloma
OT  - observational
OT  - real-world
COIS- Conflict of interests: Dr Betty Yang is employee of Johnson & Johnson Taiwan Ltd.
EDAT- 2019/03/13 06:00
MHDA- 2019/03/13 06:01
PMCR- 2019/01/18
CRDT- 2019/03/13 06:00
PHST- 2018/06/12 00:00 [received]
PHST- 2018/10/22 00:00 [accepted]
PHST- 2019/03/13 06:00 [entrez]
PHST- 2019/03/13 06:00 [pubmed]
PHST- 2019/03/13 06:01 [medline]
PHST- 2019/01/18 00:00 [pmc-release]
AID - 10.4081/oncol.2019.377 [doi]
PST - epublish
SO  - Oncol Rev. 2019 Jan 18;13(1):377. doi: 10.4081/oncol.2019.377. eCollection 2019 
      Jan 14.