Cortelazzo S, Viero P, Bellavita P, Rossi A, Buelli M, Borleri G M, Marziali S, Bassan R, Comotti B, Rambaldi A
Division of Hematology, Ospedali Riuniti, Bergamo, Italy.
J Clin Oncol. 1995 Apr;13(4):935-41. doi: 10.1200/JCO.1995.13.4.935.
To compare the hematologic recovery after high-dose chemotherapy and circulating peripheral-blood progenitor-cell (PBPC) transplant between patients who received recombinant human granulocyte colony-stimulating factor (G-CSF) (treated group) and those who did not (control group).
From December 1992 through June 1994, two sequential and consecutive cohorts of 20 patients each with histologically proven non-Hodgkin's lymphoma (NHL) received high-dose chemotherapy (carmustine [BCNU], cytarabine [Ara-C], etoposide and melphalan [BEAM]) followed by PBPC transplant. The first 20 patients were treated with G-CSF (5 micrograms/kg/d) after PBPC administration. Since the time of platelet and leukocyte recovery in this group was short (< 15 days), with a narrow standard deviation from the mean value, the last 20 patients were not given G-CSF. Hematologic recovery, number of febrile days, rate of documented infections, number of hospital days, duration of gastrointestinal complications, platelet and RBC transfusions, and antibiotic requirements were compared in the two groups.
The two groups of patients were comparable according to disease status, histology, stage, bulky disease bone marrow involvement, elevated lactate dehydrogenase (LDH) level, and median number of infused CD34+ cells and colony-forming units granulocyte-macrophage (CFU-GM). The median time to reach 0.5 x 10(9)/L and 1.0 x 10(9)/L neutrophils was 2 days shorter in G-CSF group, but this difference was not statistically significant. The median times to reach 20 x 10(9)/L and 50 x 10(9)/L platelets were, respectively, 10 and 14 days in the G-CSF group and 11 and 16 days in the control group, but again this was not statistically significant. Moreover, when considering clinically relevant end points including the number of documented infections and antibiotic requirements, platelet transfusions, gastrointestinal toxicity, and days of hospitalization, no differences were demonstrated between the two groups.
Provided an optimal dose of circulating progenitors is infused, NHL patients transplanted with PBPC do not benefit by the administration of hematopoietic growth factors.
比较接受重组人粒细胞集落刺激因子（G-CSF）治疗的患者（治疗组）与未接受该治疗的患者（对照组）在大剂量化疗及循环外周血祖细胞（PBPC）移植后的血液学恢复情况。
从1992年12月至1994年6月，两个连续队列的各20例经组织学证实为非霍奇金淋巴瘤（NHL）的患者接受了大剂量化疗（卡莫司汀[BCNU]、阿糖胞苷[Ara-C]、依托泊苷和美法仑[BEAM]），随后进行PBPC移植。前20例患者在PBPC输注后接受G-CSF治疗（5微克/千克/天）。由于该组患者血小板和白细胞恢复时间较短（<15天），且与平均值的标准差较窄，后20例患者未给予G-CSF。比较两组患者的血液学恢复情况、发热天数、记录在案的感染率、住院天数、胃肠道并发症持续时间、血小板和红细胞输注情况以及抗生素需求。
两组患者在疾病状态、组织学、分期、大块病灶、骨髓受累情况、乳酸脱氢酶（LDH）水平升高情况以及输注的CD34+细胞和粒-巨噬细胞集落形成单位（CFU-GM）中位数方面具有可比性。G-CSF组达到0.5×10⁹/L和1.0×10⁹/L中性粒细胞的中位时间短2天，但这种差异无统计学意义。G-CSF组达到20×10⁹/L和50×10⁹/L血小板的中位时间分别为10天和14天，对照组分别为11天和16天，但同样无统计学意义。此外，在考虑包括记录在案的感染数量和抗生素需求、血小板输注、胃肠道毒性和住院天数等临床相关终点时，两组之间未显示出差异。
若输注了最佳剂量的循环祖细胞，接受PBPC移植的NHL患者不会因给予造血生长因子而受益。
