Randomized Trial of Filgrastim, Sargramostim, or Sequential Sargramostim and Filgrastim After Myelosuppressive Chemotherapy for the Harvesting of Peripheral-Blood Stem Cells

2000 ◽  
Vol 18 (1) ◽  
pp. 43-43 ◽  
Author(s):  
Charles H. Weaver ◽  
Kevin A. Schulman ◽  
Barbara Wilson-Relyea ◽  
Robert Birch ◽  
William West ◽  
...  
Keyword(s):  
Stem Cells ◽  
Peripheral Blood ◽  
Hospital Admissions ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Peripheral Blood Stem Cells ◽  
Platelet Recovery ◽  
Blood Stem Cells ◽  
Sequential Regimen ◽  
Chemotherapy Patients

PURPOSE: The purpose of this study was to compare the effects of filgrastim, sargramostim, or sequential sargramostim and filgrastim on CD34+ cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC). PATIENTS AND METHODS: One hundred fifty-six patients were randomized to receive filgrastim (n = 51), sargramostim (n = 52), or sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81). RESULTS: Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 × 109/L or greater (a median of 11 v 14 days; P = .0001), with fewer patients requiring RBC transfusions (P = .008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P = .013), and less intravenous antibiotic therapy (24% v 69%; P = .001). Patients who received filgrastim yielded more CD34+ cells (median, 7.1 v 2.0 × 106/kg/apheresis; P = .0001), and a higher fraction achieved 2.5 × 106 (94% v 78%; P = .021) and 5 × 106 (88% v 53%; P = .001) or more CD34+ cells/kg with fewer aphereses (median, 2 v 3; P = .002) and fewer days of growth-factor treatment (median, 12 v 14; P = .0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD34+ cells and had faster platelet recovery (P = .015), with fewer patients (P = .014) receiving fewer platelet transfusions (P = .001) than patients receiving sargramostim-mobilized PBSCs. CONCLUSION: It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD34+ cells and reduction of toxicities after MC.

Mobilization, Harvesting and Transplantation of Peripheral Blood Stem Cells in Patients with Severe Refractory Systemic Lupus Erythematosus - A Single Center Experience.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5107-5107
Author(s):  
Yi Xiao ◽  
Hanyin Sun ◽  
Jianfeng Zhou ◽  
Wenli Liu ◽  
Yicheng Zhang
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Stem Cells ◽  
Lupus Erythematosus ◽  
Peripheral Blood ◽  
High Dose Chemotherapy ◽  
Salvage Treatment ◽  
High Dose ◽  
Systemic Lupus ◽  
Peripheral Blood Stem Cells ◽  
Blood Stem Cells

Abstract The prognosis for patients with severe refractory systemic lupus erythematosus (SLE) is poor; High dose chemotherapy with hematopoietic stem cell support is a salvage treatment under investigation for these patients. In our center, 17 patients with severe refractory SLE received autologous peripheral blood stem cells transplantation (PBSCT); Peripheral blood stem cells were mobilized with cyclophosphamide 4g/m2 and granulocyte colony-stimulating factor (G-CSF) 5 μg/kg/day. Enough PBSC were collected in all patients. There’s no mobilization-related mortality, while 3 patients developed active lupus after mobilization which was controlled by slightly increasing the dosage of steroids. Following conditioning with cyclophosphamide 6g/m2 plus anti-thymocyte globulin (ATG, 20mg/kg/d, 5 days), cryopreserved PBSC (mean MNC 4.28×108/kg and CD34(+) cell 2.48×106/kg) were infused. Median ANC and platelet engraftment time were days +11 and +12 after transplantation, respectively. Treatment related complications include mucositis (14/17), infection (12/17), liver malfuction (10/17), edema or/and heart failure (3/17), renal failure (2/17), bleeding (5/17); One patient died from cerebral hemorrhage. Median follow-up is 22 months (9–28 months); All the patients improved with the SLEDAI score reduced from 25.2±6.6 before to 9.7±1.2 3 months after transplantation; Steroids were stopped or maintained at very low dose (equal to 5 to 7.5 mg/d predinisone). One patient had overt lupus relapse 8 months following transplant Conclusions Mobilization, harvesting and transplantation of peripheral blood stem cells in patients with severe refractory systemic lupus erythematosus is safe; The short-term result of the approach is effective in this group of patients; More patients needed to enroll a control study to validate the role of high-dose chemotherapy/PBSCT as the salvage treatment for severe SLE.

Pegfilgrastim after High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cells Transplantation. A Single-Centre Experience in 15 Patients.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4213-4213 ◽  
Author(s):  
Carole Soussain ◽  
Laure Marec ◽  
Wajed Abarah ◽  
Christian Allard ◽  
Hassina Mallek ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Peripheral Blood ◽  
Central Nervous System Lymphoma ◽  
High Dose Chemotherapy ◽  
Fixed Dose ◽  
High Dose ◽  
Peripheral Blood Stem Cells ◽  
Blood Stem Cells ◽  
Stem Cells Transplantation

Abstract The efficacy of Pegfilgrastim (PF) in decreasing the duration of neutropenia has been proved after standard dose of chemotherapy. Results of PF after high dose chemotherapy (HDC) and autologous peripheral blood stem cells transplantation ASCT) are lacking. We studied the efficacy of PG in patients receiving HDC and ASCT for lymphoproliferative disease. Fifteen consecutive patients (8 males; 7 females) were onrolled in the study from September 2003 through March 2004. Median age of the patients was 56 years. Diseases were multiple myeloma in 5 patients, diffuse large cell non-Hodgkin’s lymphoma (NHL) in 3 patients, follicular lymphoma in 4 patients, mantle cell lymphoma in one patient, and primary central nervous system lymphoma PCNSL) in 2 patients. All patients were eligible for HDC and ASCT per institutional criteria. Stem cells were collected with peripheral blood pheresis after high dose cyclophosphamide (7 cases); high dose Ara-c (5 cases); ifosfamide (1 case); CHOP-like chemotherapy (1 case); or in steady state (1 case). All the patients received daily G-CSF (5 to 10 mcg/kg). Three different conditioning regimens were used. Patients with multiple myeloma received high dose melphalan (200 mg/m²), patients with PCNSL received a combination of high dose Thiotepa (750 mg/m²), Busulfan (12 mg/kg), and Cyclophosphamide (120 mg/kg), and patients with NHL received a BEAM chemotherapy. PF was administered as a single subcutaneous injection of 6 mg at day +3 after stem cell infusion, except for one patient whose injection was done on day 4. No adverse event attributable to PF was observed. There were no toxic death on study. All patients engrafted neutrophils and platelets. The median time to neutrophils engraftment (> 500/mm3) was 7 days (range, 4–12). Febrile neutropenia was almost constant (14/15) but never exceed OMS grade 2. Median number of days with IV antibiotics was 7 days (range 5–22). These preliminary data show that a fixed dose of 6 mg of PF given subcutaneously at day +3 after HDC and ASCT is safe and effective. A cost efficacy study is warranted to compare PF and daily dose of standard G-CSF after ASCT.

Tandem Autotransplants’ Peripheral Blood Stem Cells Following Sequent High-Dose CHEOP Chemotherapy for Aggressive Lymphoma.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5510-5510
Author(s):  
Yi Luo ◽  
He Huang ◽  
Zhen Cai ◽  
Maofang Lin
Keyword(s):  
Stem Cells ◽  
Peripheral Blood ◽  
High Dose Chemotherapy ◽  
Aggressive Lymphoma ◽  
High Dose ◽  
Sequential Chemotherapy ◽  
Peripheral Blood Stem Cells ◽  
Single High Dose ◽  
Blood Stem Cells ◽  
Disease Free

Abstract The majority of poor-risk lymphoma patients are not cured with conventional chemotherapy. There is evidence for superiority of single high-dose chemotherapy in such patients, but many still die from recurrent disease. Strategies to improve survival in these poor-risk patients include dose-intensification with high-dose chemotherapy and PBSC support autologous transplantation. These more aggressive strategies are feasible and tolerable. Whether tandem transplantation will prove more effective than current single high-dose therapy in appropriately selected patients remains to be determined. The purpose of this study was to evaluate the effectivity and safety of mobilization regimen, and the effectivity and tolerance of sequential chemotherapy combined with tandem autotransplant in aggressive lymphoma. In this study, the clinical data of 5 patients with recurrent, aggressive lymphoma treated with of sequential chemotherapy combined with tandem autotransplant were analysed respectively. The group included 1 HD and 4 NHL. Mobilization regimen was CHOEP combined with G-CSF (5ug•kg−1•d−1). The conditioning regimen for the tandem transplantation was high-dose CHEOP. The interval of the two autotransplantation was 9(5~31)weeks. In tandem autotransplant, the cell number of MNC which was transfused was 3.05 (ranged from 1.91~4.14) ×108 •kg−1 and 3.55 (ranged from 2.23~6.0) ×108•kg−1; CD34+ was 4.11 (ranged from 2.59~4.94) ×106•kg−1 and 5.70 (ranged from 2.77~10.6) ×106•kg−1; CFU-GM was 2.96 (ranged from 2.01~4.54) ×105•kg−1 and 2.44 (ranged from 1.78~2.9) ×105•kg−1 respectively (P>0.05). All patients reached prompt and sustained hemotopoietic reconstitution. The interval of ANC ≥0.5×109/L was 10 days (ranged from 8~12) and 10.5 days (ranged from 9~12); Pt ≥2.0×109/L was 11 days (ranged from 10~14) and 12.5 days (ranged from 10~15) respectively (P>0.05). Four patients were alive while 3 was in disease-free with median 46 (range 9~88) months. The overall survival was 80%, and the disease-free survival was 60%. In the conclusion, the method of sequential high-dose CHEOP chemotherapy combined with tandem autotransplant of peripheral blood stem cells for aggressive lymphoma is safe and effective.

Filgrastim-mobilized peripheral-blood stem cells can be stored at 4 degrees and used in autografts to rescue high-dose chemotherapy

1995 ◽  
Vol 48 (2) ◽  
pp. 100-103 ◽  
Author(s):  
Guillermo J. Ruiz-Argüelles ◽  
Alejandra Larregina-Díez ◽  
Beatrlz Pérez-Romano ◽  
Antonio Marín-López ◽  
Alejandra Larregina-Diez ◽  
...  
Keyword(s):  
Stem Cells ◽  
Peripheral Blood ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Peripheral Blood Stem Cells ◽  
Blood Stem Cells ◽  
Mobilized Peripheral Blood
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