Kopf B, De Giorgi U, Vertogen B, Monti G, Molinari A, Turci D, Dazzi C, Leoni M, Tienghi A, Cariello A, Argnani M, Frassineti L, Scarpi E, Rosti G, Marangolo M
Department of Oncology and Hematology, Istituto Oncologico Romagnolo, Santa Maria delle Croci Hospital, Ravenna, Italy.
Bone Marrow Transplant. 2006 Sep;38(6):407-12. doi: 10.1038/sj.bmt.1705465.
We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or molgramostim at 5 microg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1-3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 x 10(6)/kg in the filgrastim arm versus 5.8 x 10(6)/kg in the lenograstim arm versus 4.0 x 10(6)/kg in the molgramostim arm (P=0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) (P<0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (P<0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.
我们开展了一项前瞻性随机临床试验,以评估在特定疾病化疗方案后使用非格司亭、来格司亭和莫拉司亭的动员效果。动员方案包括45例(44%)患者使用高剂量环磷酰胺,22例(21%)患者使用顺铂/异环磷酰胺/依托泊苷或长春碱,随后随机分为接受5μg/kg/天的非格司亭、来格司亭或莫拉司亭治疗。103例患者被随机分组,82例(79%)进行了单采术。44例(43%)患者未接受过化疗,而59例(57%)患者接受过预处理。每位患者进行单采术的中位数为1次(范围为1 - 3次)。动员后获得的CD34+细胞中位数在非格司亭组为8.4×10⁶/kg,来格司亭组为5.8×10⁶/kg,莫拉司亭组为4.0×10⁶/kg(P = 0.1)。在生长因子给药天数中位数方面观察到统计学显著差异,来格司亭组(12天)优于非格司亭组(13天)和莫拉司亭组(14天)(P<0.0001),在未接受过化疗的患者亚组(12天)与接受过预处理的患者亚组(14天)之间也存在统计学显著差异(P<0.001)。总之,所有三种生长因子在动员外周血祖细胞方面均有效,不同方案之间CD34+细胞产量无统计学显著差异,单采术时间可能因不同的动员方案而受到混淆。