Gazitt Y, Callander N, Freytes C O, Shaughnessy P, Liu Q, Tsai T W, Devore P
University of Texas, Health Science Center, Audie L. Murphy Memorial VA Hospital, San Antonio 78284, USA.
J Hematother Stem Cell Res. 2000 Oct;9(5):737-48. doi: 10.1089/15258160050196786.
We designed a randomized, prospective three-arm mobilization study to determine the kinetics of peripheral blood stem cell (PBSC) mobilization in 60 non-Hodgkin's lymphoma (NHL) patients primed with cyclophosphamide (CTX) in combination with granulocyte colony-stimulating factor (G-CSF) (arm A), granulocyte-macrophage (GM)-CSF (arm B) or GM-CSF/G-CSF (arm C). We also compared mobilization and transplant-related toxicities, pre- and post-transplant support and the probability of survival among the three arms. To date, 35 patients have been enrolled in the study; 13 patients have been enrolled in arm A, 10 patients in arm B, and 13 patients in arm C. Successful collection of the target of > or = 2 X 10(6) CD34+ cells/kg in one to four apheresis collections was 10/13, 6/10, and 7/12 in arms A, B, and C, respectively. The differences between arms were not statistically significant. The median time to achieve the target CD34+ cells in patients who successfully mobilized the target CD34+ cells was 3 days, 2 days, and 1 day, in patients in arms A, B, and C, respectively. The time for neutrophil engraftment was 11, 10, and 10 days in arms A, B, and C, respectively. The time for platelet engraftment was 11 days for patients in all arms of the study. Most importantly, no significant differences were observed among the three arms in the duration of neutropenic fever, the extent of mucositis, diarrhea, and nausea/vomiting, or in the number of units of platelets or red cells transfused after transplantation. Risk factors associated with poor mobilization were > or = 3 regimens of chemotherapy prior to mobilization, older age, and disease histology (follicular versus diffuse). Therefore, we conclude that the type of growth factor used for mobilization did not play a major role in the outcome of mobilization and recommend mobilizing NHL patients before they receive multiple regimens of chemotherapy.
我们设计了一项随机、前瞻性三臂动员研究,以确定60例接受环磷酰胺(CTX)联合粒细胞集落刺激因子(G-CSF)预处理的非霍奇金淋巴瘤(NHL)患者(A组)、粒细胞-巨噬细胞(GM)-CSF预处理的患者(B组)或GM-CSF/G-CSF预处理的患者(C组)外周血干细胞(PBSC)动员的动力学情况。我们还比较了三组之间的动员情况、移植相关毒性、移植前后的支持治疗以及生存概率。迄今为止,已有35例患者入组该研究;A组入组13例患者,B组入组10例患者,C组入组13例患者。在一至四次单采中成功采集到≥2×10⁶个CD34⁺细胞/kg目标的比例,A组为10/13,B组为6/10,C组为7/12。三组之间的差异无统计学意义。成功动员出目标CD34⁺细胞的患者达到目标CD34⁺细胞的中位时间,A组为3天,B组为2天,C组为1天。中性粒细胞植入时间,A组为11天,B组为10天,C组为10天。研究所有组患者的血小板植入时间均为11天。最重要的是,三组在中性粒细胞减少性发热持续时间、黏膜炎程度、腹泻、恶心/呕吐情况,或移植后输注血小板或红细胞的单位数量方面均未观察到显著差异。与动员效果不佳相关的危险因素为动员前≥3种化疗方案、年龄较大以及疾病组织学类型(滤泡型与弥漫型)。因此,我们得出结论,用于动员的生长因子类型在动员结果中未起主要作用,并建议在NHL患者接受多种化疗方案之前进行动员。
J Hematother Stem Cell Res. 2001-2