Prakash Vadlamani Surya, Malik Prabhat Singh, Sahoo Ranjit Kumar, Pramanik Raja, Choudhary Priyanshu, Varshney Ankur Nandan, Kumar Lalit
Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.
Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.
Clin Lymphoma Myeloma Leuk. 2022 Jan;22(1):44-51. doi: 10.1016/j.clml.2021.07.030. Epub 2021 Aug 2.
We used plerixafor in 'a risk adapted approach' for stem cell mobilization for multiple myeloma (MM) patients prior to autologous stem cell transplantation (ASCT).
Between January, 2017 and December, 2019 105 consecutive patients of MM were recruited (Study Cohort). Patients received inj G-CSF 10 µg/kg in 2 divided doses for 5 days. Day 4 peripheral blood (PB) CD34+ count was used as a guide; if count was < 20 cells/µl, patients received plerixafor. For those with ≥ 20 cells/µl apheresis was commenced on day 5. We compared their outcome with 156 MM patients transplanted between 2012 and 2016 with G-CSF mobilized PB stem cells (Control Cohort). Primary end point was to collect ≥2.0 × 10 CD34+ cells/kg (minimal harvest). Secondary end points were: no of apheresis sessions, percentage of patients with optimal stem cell harvest (≥4.0 × 10 CD34+ cells/kg) and cost analysis. An intent to treat analysis was done.
96.2% of patients achieved ≥ 2.0 × 10 CD34+ cells/kg in the study cohort vs. 87.2% in the control cohort, P < .01. Mean apheresis sessions were 1.5 vs. 1.7 respectively, P < .014 . Optimal stem cell harvest was 29.5% vs. 16%,P = .23. Days for neutrophil engraftment (P < 0.025) and for IV antibiotics (P < .0017) were favorable for the study cohort. Incremental cost effectiveness ratio was $ 15.80/- and $ 10.56/- per 1% increase to achieve a minimal and optimal harvest.
Plerixafor in this risk adapted strategy resulted in successful mobilization, decreased time to engraftment and was cost effective.
我们采用普乐沙福进行“风险适应性方法”，用于多发性骨髓瘤（MM）患者在自体干细胞移植（ASCT）前的干细胞动员。
在2017年1月至2019年12月期间，连续招募了105例MM患者（研究队列）。患者接受皮下注射粒细胞集落刺激因子（G-CSF）10μg/kg，分2次给药，共5天。第4天的外周血（PB）CD34+细胞计数用作指导；如果计数<20个细胞/μl，患者接受普乐沙福治疗。对于CD34+细胞计数≥20个细胞/μl的患者，在第5天开始进行单采。我们将他们的结果与2012年至2016年间接受G-CSF动员的PB干细胞移植的156例MM患者（对照队列）进行了比较。主要终点是采集≥2.0×10⁶个CD34+细胞/kg（最小采集量）。次要终点包括：单采次数、干细胞采集量达到最佳水平（≥4.0×10⁶个CD34+细胞/kg）的患者百分比以及成本分析。进行了意向性分析。
研究队列中96.2%的患者采集到≥2.0×10⁶个CD34+细胞/kg，而对照队列中这一比例为87.2%，P<0.01。平均单采次数分别为1.5次和1.7次，P<0.014。最佳干细胞采集率分别为29.5%和16%，P=0.023。研究队列的中性粒细胞植入天数（P<0.025）和静脉使用抗生素天数（P<0.0017）更有利。实现最小采集量和最佳采集量每增加1%的增量成本效益比分别为15.80美元和每10.56美元。
在这种风险适应性策略中，普乐沙福成功实现了干细胞动员，缩短了植入时间，且具有成本效益。
