Menichella G, Lai M, Serafini R, Pierelli L, Vittori M, Ciarli M, Rumi C, Puggioni P, Scambia G, Sica S, Leone G
Catholic University, Rome, Italy.
Int J Artif Organs. 1999 May;22(5):334-41.
In this work we evaluated the efficacy of stem cell collection with Large Volume Procedures. (LVP), and analysed the importance of the CD34+ cell precount in promoting the collection of a sufficient number of CD34+ cells for transplantation, using the Univariate Logistic Regression analysis. Eighty-nine leukapheresis were performed in 49 patients with hematological malignancies and solid tumors, mobilized with chemotherapy plus Granulocyte Colony Stimulating Factor (G-CSF). For each procedure 15.8 liters of blood were processed. The median value of Nucleated Cells (NC) and CD34+ cells precount was respectively 8.29 x 10(9)/ml (range 1.13/45.4) and 43.08 x 103/ml (range 1.06/795.2). Results show the capability of LVP to collect large quantities of hemopoietic progenitors with a median CD34+ cell total yield of 215.02 x 10(6) (range 5.03/2210). The yields per patients' body weight were: CD34+ cells 3.23 x 10(6)/kg (range 0.081/41.58). The regression analysis between blood cell precounts and collection yields gave the following correlations: the CD34+ cell precount correlates with CD34+ yield (r = 0.78 p < 0.00) and with CD34+ cell yield/kg (r = 0.76 p < 0.00). The number of CD34+ cells processed correlated with the number of CD34+ cells collected/kg (r = 0.83 p < 0.000). To investigate the importance of CD 34+ cell precount in promoting CD34+ cell yields > or =2.5 x 10(6)/kg we performed a Univariate Logistic Regression analysis that showed in our patients a probability of collecting > or =2.5 x 10(6) CD34+/kg that rose from 0.6 to 0.95 for CD 34+ precounts that oscillated from 30 to 40 x 10(3) CD34+ cells/ml, respectively. The Univariate Logistic Regression gave a probability of collecting > or =2.5 x 10(6) CD34+ cells/kg that oscillated between 0.64/0.98 for values of CD34+ cells processed from 6 x 10(6)/kg to 8 x 10(6)/kg, p < 0.000. Sixty-three percent of patients reached the target dose of 2.5 x 10(6) CD34+ cells/kg with only one LVP. Until now 12 patients have been transplanted and all have had a prompt and complete lasting recovery. These results confirm the efficacy of LVP in harvesting hemopoietic progenitors and their ability in reconstituting hemopoiesis of transplanted patients, enabling the estimation of CD34+ precounts and CD34+ cells processed values, highly predictive for the collection of > or =2.5 x 10(6) CD34+ cells/kg. Furthermore, the Logistic Model suggests that the best strategy to plan a successful CD34+ cell collection procedure is to identify for each patient the amount of CD34+ cells/kg to be processed rather than the fixed processing of 3/5 blood volumes in all patients.
在本研究中,我们评估了大容量程序(LVP)采集干细胞的疗效,并使用单变量逻辑回归分析,分析了CD34+细胞预计数在促进采集足够数量的CD34+细胞用于移植方面的重要性。对49例血液系统恶性肿瘤和实体瘤患者进行了89次白细胞单采,这些患者通过化疗加粒细胞集落刺激因子(G-CSF)进行动员。每次程序处理15.8升血液。有核细胞(NC)和CD34+细胞预计数的中位数分别为8.29×10⁹/ml(范围1.13/45.4)和43.08×10³/ml(范围1.06/795.2)。结果显示LVP能够采集大量造血祖细胞,CD34+细胞总产率中位数为215.02×10⁶(范围5.03/2210)。每患者体重的产量为:CD34+细胞3.23×10⁶/kg(范围0.081/41.58)。血细胞预计数与采集产量之间的回归分析得出以下相关性:CD34+细胞预计数与CD34+产量相关(r = 0.78,p < 0.00),与每千克体重CD34+细胞产量相关(r = 0.76,p < 0.00)。处理的CD34+细胞数量与每千克体重采集的CD34+细胞数量相关(r = 0.83,p < 0.000)。为了研究CD34+细胞预计数在促进CD34+细胞产量≥2.5×10⁶/kg方面的重要性,我们进行了单变量逻辑回归分析,结果显示在我们的患者中,对于CD34+预计数在30至40×10³ CD34+细胞/ml之间波动的情况,采集≥2.5×10⁶ CD34+/kg的概率从0.6升至0.95。单变量逻辑回归得出,对于每千克体重处理的CD34+细胞数量在6×10⁶/kg至8×10⁶/kg之间波动的情况,采集≥2.5×10⁶ CD34+细胞/kg的概率在0.64/0.98之间,p < 0.000。63%的患者仅通过一次LVP就达到了2.5×10⁶ CD34+细胞/kg的目标剂量。到目前为止,已有12例患者接受了移植,所有患者均迅速且完全持久地康复。这些结果证实了LVP在采集造血祖细胞方面的疗效及其在重建移植患者造血功能方面的能力,能够估计CD34+预计数和处理的CD34+细胞数量,对采集≥2.5×10⁶ CD34+细胞/kg具有高度预测性。此外,逻辑模型表明,规划成功的CD34+细胞采集程序的最佳策略是为每个患者确定要处理的每千克体重CD34+细胞数量,而不是对所有患者固定处理3/5血容量。