Ri Masaki, Matsue Kosei, Sunami Kazutaka, Shimazaki Chihiro, Hayashi Akio, Sunaga Yoshinori, Sasaki Toru, Suzuki Kenshi
Department of Hematology and Oncology, Nagoya City University Hospital, 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan.
Department of Hematology and Oncology, Kameda Medical Center, Chiba, Japan.
Int J Hematol. 2017 Oct;106(4):562-572. doi: 10.1007/s12185-017-2255-8. Epub 2017 May 19.
To evaluate the efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells (HSCs) for autologous transplantation in Japanese patients with multiple myeloma (MM). In a randomized study, patients received G-CSF (filgrastim, 400 µg/m/day) for 4 days prior to the first dose of plerixafor. Starting on Day 4 evening and for up to 4 days, patients received either plerixafor (240 µg/kg/day) + G-CSF group (PG group) or G-CSF alone (G group). Daily apheresis started on Day 5 for up to 4 days, or until ≥6 × 10 CD34+ cells/kg were collected. A total of 7 patients were randomized in each treatment group. Five patients in PG group and no patients in G group achieved a collection of ≥6 × 10 CD34+ cells/kg in ≤2 days of apheresis [difference of 71.4% (90%CI 29-100%)]. These results were supported by the shorter median time to collect ≥6 × 10 CD34+ cells/kg (2 days in PG group; no patient in G group). The incidence of treatment emergent adverse events (TEAEs) was higher in PG group than in G group. Plerixafor was well tolerated, and effective for the mobilization/collection of peripheral HSCs for autologous transplantation in Japanese patients with MM.
评估普乐沙福用于动员/采集日本多发性骨髓瘤（MM）患者外周造血干细胞（HSCs）以进行自体移植的疗效和安全性。在一项随机研究中，患者在首次使用普乐沙福前4天接受粒细胞集落刺激因子（非格司亭，400μg/m²/天）。从第4天晚上开始，持续4天，患者接受普乐沙福（240μg/kg/天）+粒细胞集落刺激因子组（PG组）或仅接受粒细胞集落刺激因子（G组）。从第5天开始进行每日一次的血细胞分离术，持续4天，或直至采集到≥6×10⁶个CD34⁺细胞/kg。每个治疗组共有7名患者被随机分组。PG组有5名患者，G组无患者在血细胞分离术≤2天内实现采集到≥6×10⁶个CD34⁺细胞/kg[差异为71.4%（90%CI 29 - 100%）]。这些结果得到了采集≥6×10⁶个CD34⁺细胞/kg的中位时间较短的支持（PG组为2天；G组无患者达到）。PG组治疗中出现的不良事件（TEAEs）发生率高于G组。普乐沙福耐受性良好，对日本MM患者动员/采集外周HSCs以进行自体移植有效。
