PMID- 34455570
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220224
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 9
IP  - 1
DP  - 2022 Mar
TI  - Safety and Effectiveness of Plerixafor for Peripheral Blood Stem Cell 
      Mobilization in Autologous Stem Cell Transplantation: Results of a Post-Marketing 
      Surveillance Study.
PG  - 63-78
LID - 10.1007/s40801-021-00276-1 [doi]
AB  - BACKGROUND: Plerixafor was approved in Japan in 2016 for peripheral blood stem 
      cell (PBSC) mobilization in autologous stem cell transplantation (A-SCT). 
      OBJECTIVE: Our objective was to evaluate the safety and effectiveness of 
      plerixafor in Japanese patients undergoing A-SCT for various indications in 
      real-world practice. PATIENTS AND METHODS: This post-marketing surveillance study 
      included Japanese patients initiating PBSC mobilization with plerixafor for 
      A-SCT. Safety assessments included the incidence of adverse events (AEs) 
      including serious AEs, adverse drug reactions (ADRs), and laboratory variables. 
      Effectiveness assessments were the proportion of patients with the target CD34+ 
      cell yield (>/=2 x 10(6) cells/kg) </=4 days after plerixafor administration and the 
      number of days required to reach the target CD34+ cell yield. RESULTS: In total, 
      785 patients were registered, and the safety and effectiveness analysis sets 
      comprised 764 and 717 patients, respectively. ADRs occurred in 12.2% of patients, 
      with gastrointestinal disorders (5.5%), laboratory investigations (4.5%), and 
      blood and lymphatic system disorders (3.0%) being the most common. A total of 
      71.1% of patients had the target CD34+ cell yield within </=4 days of treatment, 
      with a mean (standard deviation) of 1.3 (0.7) days to reach the target CD34+ cell 
      yield. Over 80% of patients with a baseline CD34+ cell count >2 cells/muL had a 
      target CD34+ cell yield within </=4 days of treatment. CONCLUSIONS: This large 
      post-marketing surveillance study provided real-world evidence detailing the 
      safety and effectiveness of plerixafor for PBSC mobilization in Japanese patients 
      undergoing A-SCT. Importantly, no new safety concerns were identified, and the 
      safety profile of plerixafor was consistent with the established profile of this 
      drug.
CI  - (c) 2021. The Author(s).
FAU - Tsukada, Nobuhiro
AU  - Tsukada N
AD  - Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
FAU - Nishikori, Momoko
AU  - Nishikori M
AD  - Department of Hematology/Oncology, Graduate School of Medicine, Kyoto University, 
      Kyoto, Japan.
FAU - Goto, Hiroaki
AU  - Goto H
AD  - Division of Hematology/Oncology, Kanagawa Children's Medical Center, Kanagawa, 
      Japan.
FAU - Kanamori, Rie
AU  - Kanamori R
AD  - Sanofi Genzyme Medical, Oncology Medical, Sanofi K.K., Tokyo, Japan.
FAU - Nishina, Satoshi
AU  - Nishina S
AD  - Medical Affairs, Post-Authorization Regulatory Studies, Sanofi K.K., Tokyo, 
      Japan.
FAU - Seto, Takashi
AU  - Seto T
AD  - Medical Affairs, Post-Authorization Regulatory Studies, Sanofi K.K., Tokyo, 
      Japan.
FAU - Iida, Shinsuke
AU  - Iida S
AUID- ORCID: 0000-0002-4951-960X
AD  - Department of Hematology and Oncology, Nagoya City University Institute of 
      Medical and Pharmaceutical Sciences, Nagoya, Japan. iida@med.nagoya-cu.ac.jp.
LA  - eng
PT  - Journal Article
DEP - 20210829
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC8844333
COIS- Nobuhiro Tsukada has received payment for lectures, including service on 
      speaker's bureaus, from Takeda Pharmaceutical Company Limited and Sanofi K.K. 
      Momoko Nishikori has received grants from Eisai Co., Ltd. and Sumitomo Dainippon 
      Pharma Co., Ltd. and fees for participation in review activities such as data 
      monitoring boards from Sanofi K.K. Hiroaki Goto has received fees for 
      participation in review activities such as data monitoring boards from Amgen 
      K.K., Novartis Pharma K.K., Nippon Shinyaku Co. Ltd., and Bayer Yakuhin Ltd.; has 
      received payment for writing or reviewing manuscripts and delivering lectures, 
      including service on speaker's bureaus, from Amgen K.K. Rie Kanamori and Takashi 
      Seto are employees of Sanofi K.K. Satoshi Nishina is an employee of Sanofi K.K. 
      and holds stocks/stock options in this company. Shinsuke Iida has received 
      grants, or has grants pending on behalf of Sanofi K.K., Takeda Pharmaceutical 
      Company Limited, Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb K.K., Celgene 
      Corporation, Janssen Pharmaceutical K.K., Daiichi Sankyo Co. Ltd., Chugai 
      Pharmaceutical Co. Ltd., Kyowa Kirin Co. Ltd., GlaxoSmithKline, and Abbvie Inc.; 
      and has received consulting fees or honorarium from Sanofi K.K., Takeda 
      Pharmaceutical Company Limited, Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb 
      K.K., Celgene Corporation, Janssen Pharmaceutical K.K., Daiichi Sankyo Co. Ltd.
EDAT- 2021/08/30 06:00
MHDA- 2021/08/30 06:01
PMCR- 2021/08/29
CRDT- 2021/08/29 21:09
PHST- 2021/08/09 00:00 [accepted]
PHST- 2021/08/30 06:00 [pubmed]
PHST- 2021/08/30 06:01 [medline]
PHST- 2021/08/29 21:09 [entrez]
PHST- 2021/08/29 00:00 [pmc-release]
AID - 10.1007/s40801-021-00276-1 [pii]
AID - 276 [pii]
AID - 10.1007/s40801-021-00276-1 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2022 Mar;9(1):63-78. doi: 10.1007/s40801-021-00276-1. 
      Epub 2021 Aug 29.