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Application of Mecapegfilgrastim for Peripheral Blood Hematopoietic Stem Cell Mobilization in Patients With Hematologic Neoplasms and Analysis of Predictors for Poor Mobilization
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摘要:
目的 评估硫培非格司亭用于血液肿瘤患者外周血造血干细胞（peripheral blood hematopoietic stem cell, PBSC）动员的效果，探讨PBSC采集的影响因素。 方法 回顾性分析2016年4月–2022年5月在绵阳市中心医院血液科行PBSC动员的病例，比较含硫培非格司亭（硫培组，28例）和含重组人粒细胞集落刺激因子（recombinant human granulocyte colony-stimulating factor, rhG-CSF）（rhG-CSF组，30例 ）两组的CD34+细胞采集成功率，并分析采集失败的影响因素。 结果 硫培组和rhG-CSF组CD34+细胞采集成功率分别为75.0%和63.3%，CD34+细胞采集中位值分别为3.37×106/kg和2.68×106/kg，差异均无统计学意义。经普乐沙福补救的硫培组和rhG-CSF组CD34+细胞采集中位值分别为4.23×106/kg和3.26×106/kg，差异无统计学意义。两组在造血系统重建和感染等方面也无明显差异（P>0.05）。多因素分析发现非浆细胞疾病〔比值比（odds ratio, OR）=19.697，95%置信区间（confidence interval, CI）：1.501～258.537，P=0.023〕、采集前贫血（OR=18.571，95%CI：1.354～254.775，P=0.029）、采集前WBC<32×109 L−1（OR=85.903，95%CI：4.947～1491.807，P=0.002）是PBSC采集失败的独立危险因素。 结论 硫培非格司亭在血液肿瘤患者中的PBSC动员效果与rhG-CSF相当，且联合普乐沙福动员可行、有效。白血病和淋巴瘤、采集干细胞前贫血及WBC<32×109 L−1的患者PBSC采集失败的可能性大。 -
关键词:
- 重组人粒细胞集落刺激因子 /
- 硫培非格司亭 /
- 血液肿瘤 /
- 造血干细胞动员 /
- 影响因素分析
Abstract:Objective To evaluate the efficacy of applying mecapegfilgrastim for peripheral blood hematopoietic stem cell (PBSC) mobilization in patients with hematologic neoplasms, and to investigate the influencing factors of PBSC collection. Methods Patients who underwent PBSC mobilization in the Department of Hematology, Mianyang Central Hospital between April 2016 and May 2022 were retrospectively analyzed. The CD34+ cell collection results of two groups, the mecapegfilgrastim group (n=28), or the PEG group, and the recombinant human granulocyte colony-stimulating factor (rhG-CSF) group (n=30), were compared, and the influencing factors of collection failure were analyzed. Results The success rates of CD34+ cells collection in the PEG group and the rhG-CSF group were 75.0% and 63.3%, respectively (P>0.05). The median CD34+ cell counts were 3.37×106/kg and 2.68×106/kg, respectively, showing no significant difference. After combined mobilization with plerixafor, the median counts of CD34+ cells collected in the PEG group and rhG-CSF group were 4.23×106/kg and 3.26×106/kg, respectively, showing no significant difference (P>0.05). There was no significant difference in hematopoietic system reconstruction and infections between the two groups (P>0.05). Multivariate analysis found non-plasma cell disease (odds ratio [OR]=19.697, 95% confidence interval [CI] : 1.501-258.537, P=0.023), anemia before collection (OR=18.571, 95% CI: 1.354-254.775, P=0.029) and white blood cell count before collection under 32×109 L−1 (OR=85.903, 95% CI: 4.947-1491.807, P=0.002) to be independent risk factors for PBSC collection failure. Conclusion The effect of PBSC mobilization with mecapegfilgrastim was comparable to that of rhG-CSF in patients with hematologic neoplasms. Furthermore, combined mobilization with plerixafor was feasible and effective. Patients with leukemia or lymphoma, anemia, and WBC<32×109 L−1 before stem cell collection have a high probability of PBSC collection failure. -
表 1 硫培组与rhG-CSF组的临床特点比较
Table 1. Comparison of baseline clinical characteristics between the PEG and rhG-CSF groups
Clinical characteristic PEG group (n=28) rhG-CSF group (n=30) P Age/yr., median (range) 52 (30-66) 47 (15-63) 0.272 Sex/case (%) 0.771 Male 16 (57.1) 16 (53.3) Female 12 (42.9) 14 (46.7) Diagnosis/case (%) 0.099 Acute leukemia 3 (10.7) 10 (33.3) Lymphoma 9 (32.1) 9 (30.0) Plasma cell disease 16 (57.1) 11 (36.7) ECOG score/case (%) 0.871 0-1 20 (71.4) 22 (73.3) 2-4 8 (28.6) 8 (26.7) Body mass index/(kg/m2), $ \bar x \pm s $ 23.03±3.06 24.96±4.56 0.066 Lymphoma risk stratification/case (%)* 1.000 Low-intermediate 4 (44.4) 4 (44.4) High 2 (22.2) 2 (22.2) Unknown 3 (33.3) 3 (33.3) MM ISS stage/case (%)# 0.484 Ⅰ 6 (40.0) 4 (36.4) Ⅱ 8 (53.3) 4 (36.4) Ⅲ 1 (6.7) 3 (27.3) Number of chemotherapy cycles/case (%) 0.198 <5 14 (50.0) 10 (33.3) ≥5 14 (50.0) 20 (66.7) Lenalidomide exposure/case (%) 0.107 Yes 11 (39.3) 6 (20.0) No 17 (60.7) 24 (80.0) Pre-mobilization disease status/case (%) 1.000 Newly diagnosed 24 (85.7) 25 (83.3) Remission after recurrence 4 (14.3) 5 (16.7) Disease response pre-mobilization/case (%)△ 1.000 CR 13 (61.9) 13 (61.9) VGPR 5 (23.8) 6 (28.6) PR 3 (14.3) 2 (9.5) Combination chemotherapy/case (%) 0.000 Yes 1 (3.6) 13 (43.3) No 27 (96.4) 17 (56.7) Combination plerixafor/case (%) 0.118 Yes 16 (57.1) 11 (36.7) No 12 (42.9) 19 (63.3) rhG-CSF: recombinant human granulocyte colony stimulating factor; PEG: mecapegfilgrastim; ECOG: Eastern Cooperative Oncology Group; MM: multiple myeloma; ISS: International Staging System; CR: complete response; PR: partial response; VGPR: very good partial response. * There were 9 cases in the PEG group and 9 cases in the rhG-CSF group; # there were 15 cases in the PEG group and 11 cases in the rhG-CSF group; △ there were 21 cases in the PEG group and 21 cases in the rhG-CSF group. 
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表 2 硫培组与rhG-CSF组的动员疗效比较
Table 2. Comparison of mobilization effect in the PEG group and the rhG-CSF group
Characteristic PEG group (n=28) rhG-CSF group (n=30) P Pre-mobilization WBC/(×109 L−1), median (range) 4.75 (1.19-20.04) 4.56 (1.68-8.10) 0.166 Pre-mobilization lymphocyte/monocyte count ratio (median [range]) 1.81 (0.84-4.14) 2.26 (0.15-6.19) 0.238 Pre-mobilization HGB/(g/L), median (range) 118 (59-159) 122 (61-139) 0.913 Pre-mobilization PLT/(×109 L−1), median (range) 169 (74-306) 165 (7-498) 0.539 Pre-collection WBC/(×109 L−1), $ \bar x \pm s $ 49.97±19.27 41.51±14.86 0.066 Pre-collection lymphocyte/monocyte count ratio (midian [range]) 0.55 (0.28-3.74) 0.60 (0.19-4.22) 0.363 Pre-collection HGB/(g/L), $ \bar x \pm s $ 110±21 112±20 0.823 Pre-collection PLT/(×109 L−1), median (range) 129 (49-260) 120 (68-459) 0.938 Collection of MNC/(×108/kg), median (range) 16.27 (6.88-47.60) 15.90 (3.48-36.61) 0.576 Collection of CD34+ cell counts/(×106/kg), median (range) 3.37 (0.32-13.26) 2.68 (0.05-9.85) 0.362 Mobilization efficacy/case (%) 0.614 Failure 7 (25.0) 11 (36.7) Standard 14 (50.0) 12 (40.0) Optimal 7 (25.0) 7 (23.3) Collection of CD34+ cell counts with plerixafor/(×106/kg), median (range) 4.23 (0.32-13.26) 3.26 (0.20-9.17) 0.698 Time of neutrophil implantation/d, $ \bar x \pm s $ 10±0.83 10±1.31 0.440 Time of platelet implantation/d, $ \bar x \pm s $ 12±2.62 12±1.80 0.950 Occurrence of infection/case (%)* 0.669 Yes 13 (72.2) 10 (83.3) No 5 (27.8) 2 (16.7) Transfusion of red blood cell/U, median (range) 0 (0-6) 0 (0-3) 0.773 Transfusion of PLT/therapeutic volumes, median (range) 2 (1-5) 2 (1-4) 0.928 Length of stay/d, median (range) 23 (19-30) 25 (19-39) 0.222 Thirty-one patients completed auto-HSCT process in our hospital. rhG-CSF: recombinant human granulocyte colony stimulating factor; PEG: mecapegfilgrastim; WBC: white blood cell; HGB: hemoglobin; PLT: platelet; MNC: mononuclear cell. * There were 18 cases in the PEG group and 12 cases in the rhG-CSF group.
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表 3 影响自体造血干细胞采集效果的单因素分析
Table 3. Univariate analysis for predictive factors of poor HSC mobilization
Variable Successful mobilization (n=40) Poor mobilization (n=18) P Age/yr., median (range) 52.50 (15-66) 44 (15-63) 0.029 Number of chemotherapy cycles (median [range]) 4 (3-15) 6 (4-16) 0.007 Pre-mobilization HGB/(g/L), $ \bar x \pm s $ 120.65±21.08 105.83±21.02 0.016 Pre-collection WBC/(×109 L−1), median (range) 45.83 (27.93-89.41) 31.87 (11.86-66.81) 0.001 Pre-collection lymphocyte/(×109 L−1), median (range) 2.37 (0.88-7.19) 1.75 (0.91-3.81) 0.028 Pre-collection monocyte/(×109 L−1), median (range) 4.41 (0.78-10.96) 2.50 (0.54-8.02) 0.023 Pre-collection HGB/(g/L), $ \bar x \pm s $ 115.18±19.10 101.56±20.46 0.017 Pre-collection PLT/(×109 L−1), median (range) 140.50 (49-459) 95.00 (63-235) 0.030 HSC: hematopoietic stem cell; WBC: white blood cell; HGB: hemoglobin; PLT: platelet.
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