Safety and Effectiveness of Plerixafor for Peripheral Blood Stem Cell Mobilization in Autologous Stem Cell Transplantation: Results of a Post-Marketing Surveillance Study

被引:2
作者
Tsukada, Nobuhiro [1 ]
Nishikori, Momoko [2 ]
Goto, Hiroaki [3 ]
Kanamori, Rie [4 ]
Nishina, Satoshi [5 ]
Seto, Takashi [5 ]
Iida, Shinsuke [6 ]
机构
[1] Japanese Red Cross Med Ctr, Dept Hematol, Tokyo, Japan
[2] Kyoto Univ, Grad Sch Med, Dept Hematol Oncol, Kyoto, Japan
[3] Kanagawa Childrens Med Ctr, Div Hematol Oncol, Yokohama, Kanagawa, Japan
[4] Sanofi KK, Oncol Med, Sanofi Genzyme Med, Tokyo, Japan
[5] Sanofi KK, Postauthorizat Regulatory Studies, Med Affairs, Tokyo, Japan
[6] Nagoya City Univ, Dept Hematol & Oncol, Inst Med & Pharmaceut Sci, Nagoya, Aichi, Japan
关键词
BONE-MARROW-TRANSPLANTATION; HIGH-DOSE CHEMOTHERAPY; COLONY-STIMULATING FACTOR; HODGKIN-LYMPHOMA; PROGENITOR; POOR; COLLECTION; DISEASE; YIELDS;
D O I
10.1007/s40801-021-00276-1
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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/mu L 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.
引用
收藏
页码:63 / 78
页数:16
相关论文
共 42 条
[21]   DOSE INTENSIFICATION WITH AUTOLOGOUS BONE-MARROW TRANSPLANTATION IN RELAPSED AND RESISTANT HODGKINS-DISEASE - RESULTS OF A BNLI RANDOMIZED TRIAL [J].
LINCH, DC ;
WINFIELD, D ;
GOLDSTONE, AH ;
MOIR, D ;
HANCOCK, B ;
MCMILLAN, A ;
CHOPRA, R ;
MILLIGAN, D ;
HUDSON, GV .
LANCET, 1993, 341 (8852) :1051-1054
[22]   Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study [J].
Matsue, Kosei ;
Kumagai, Kyoya ;
Sugiura, Isamu ;
Ishikawa, Takayuki ;
Igarashi, Tadahiko ;
Sato, Tsutomu ;
Uchiyama, Michihiro ;
Miyamoto, Toshihiro ;
Ono, Takaaki ;
Ueda, Yasunori ;
Kiguchi, Toru ;
Sunaga, Yoshinori ;
Sasaki, Toru ;
Suzuki, Kenshi .
INTERNATIONAL JOURNAL OF HEMATOLOGY, 2018, 108 (05) :524-534
[23]  
Mohammadi Saeed, 2017, Int J Hematol Oncol Stem Cell Res, V11, P78
[24]   Poor peripheral blood stem cell mobilization affects long-term outcomes in multiple myeloma patients undergoing autologous stem cell transplantation [J].
Moreb, Jan S. ;
Byrne, Michael ;
Shugarman, Ilicia ;
Zou, Fei ;
Xiong, Sican ;
May, William S. ;
Norkin, Maxim ;
Hiemenz, John ;
Brown, Randall ;
Cogle, Christopher ;
Wingard, John R. ;
Hsu, Jack W. .
JOURNAL OF CLINICAL APHERESIS, 2018, 33 (01) :29-37
[25]   Predictive factors for successful stem cell mobilization in patients with indolent lymphoproliferative disorders previously treated with fludarabine [J].
Morgan, SJ ;
Seymour, JF ;
Grigg, A ;
Matthews, JP ;
Prince, HM ;
Wolf, MM ;
Januszewicz, EH .
LEUKEMIA, 2004, 18 (05) :1034-1038
[26]   Impact of CD34+pre-counting and plerixafor on autologous peripheral blood stem cell collection in Japanese university hospitals in eight years [J].
Nakamura, Yuki ;
Okubo, Mitsuo ;
Furuta, Yoshiaki ;
Tokida, Miho ;
Ichikawa, Kayoko ;
Ohsaka, Akimichi .
TRANSFUSION AND APHERESIS SCIENCE, 2019, 58 (06)
[27]   Hematopoietic stem cell transplantation in Europe 2014: more than 40000 transplants annually [J].
Passweg, J. R. ;
Baldomero, H. ;
Bader, P. ;
Bonini, C. ;
Cesaro, S. ;
Dreger, P. ;
Duarte, R. F. ;
Dufour, C. ;
Kuball, J. ;
Farge-Bancel, D. ;
Gennery, A. ;
Kroeger, N. ;
Lanza, F. ;
Nagler, A. ;
Sureda, A. ;
Mohty, M. .
BONE MARROW TRANSPLANTATION, 2016, 51 (06) :786-792
[28]   Poor mobilization is an independent prognostic factor in patients with malignant lymphomas treated by peripheral blood stem cell transplantation [J].
Pavone, V ;
Gaudio, F ;
Console, G ;
Vitolo, U ;
Iacopino, P ;
Guarini, A ;
Liso, V ;
Perrone, T ;
Liso, A .
BONE MARROW TRANSPLANTATION, 2006, 37 (08) :719-724
[29]   Progenitor cell yields are frequently poor in patients with histologically indolent lymphomas especially when mobilized within 6 months of previous chemotherapy [J].
Perry, AR ;
Watts, MJ ;
Peniket, AJ ;
Goldstone, AH ;
Linch, DC .
BONE MARROW TRANSPLANTATION, 1998, 21 (12) :1201-1205
[30]   AUTOLOGOUS BONE-MARROW TRANSPLANTATION AS COMPARED WITH SALVAGE CHEMOTHERAPY IN RELAPSES OF CHEMOTHERAPY-SENSITIVE NON-HODGKINS-LYMPHOMA [J].
PHILIP, T ;
GUGLIELMI, C ;
HAGENBEEK, A ;
SOMERS, R ;
VANDERLELIE, H ;
BRON, D ;
SONNEVELD, P ;
GISSELBRECHT, C ;
CAHN, JY ;
HAROUSSEAU, JL ;
COIFFIER, B ;
BIRON, P ;
MANDELLI, F ;
CHAUVIN, F .
NEW ENGLAND JOURNAL OF MEDICINE, 1995, 333 (23) :1540-1545