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At least 343 records · Page 19Linked to original sources
PubMed1997

Phase I study of high dose etoposide phosphatase with filgrastim (G-CSF) in the treatment of advanced refractory malignancies.

PURPOSE: To define the maximum tolerated dose of etoposide phosphate when used with G-CSF in the treatment of patients with refractory malignancies. PATIENTS AND METHODS: Eleven patients with advanced cancer refractory to standard therapy were treated with etoposide phosphate given over 1-2 hours on three consecutive days. The first cohort of patients received a total dose of 1596 mg/m2 (equivalent to etoposide 1400 mg/m2); doses were escalated in subsequent patient cohorts. G-CSF 5 micrograms/kg was administered subcutaneously from day 4 until the total leukocyte count rose to > 10,000/microL. Two courses were given at 28 day intervals. RESULTS: Toxicity produced by high dose etoposide phosphate included myelosuppression and mucositis. Three of five patients treated at the 2280 mg/m2 dose level (equivalent to etoposide 2000 mg/m2) had dose limiting toxicities (grade 4 leukopenia for 7 days, 2 patients; grade 4 mucositis + leukopenia, 1 patient). In addition, median days with severe thrombocytopenia (< 50,000/microL) rose to six days at this dose. Other toxicity was uncommon. CONCLUSIONS: In pretreated patients, the maximum tolerated dose of etoposide phosphate with G-CSF is 1938 mg/m2 (equivalent to etoposide 1700 mg/m2). Dose-limiting toxicities were myelosuppression and mucositis, as with high dose etoposide. Etoposide phosphate can be substituted for etoposide in high dose regimens; due to its greater solubility, administration can be more rapid, requires less fluid volume, and is not associated with acidosis.

Adult↗
PubMed2004

Combined administration of alpha-erythropoietin and filgrastim can improve the outcome and cost balance of autologous stem cell transplantation in patients with lymphoproliferative disorders.

We compared the use of G-CSF plus EPO in a group of 32 multiple myeloma and lymphoma patients with historical controls receiving G-CSF alone. Haemopoietic reconstitution was significantly faster in patients receiving G-CSF+EPO (group B), with a median time of 10 days to achieve an ANC count >0.5 x 10(9)/l, compared to 11 days in the historical group (A). The median duration of severe neutropenia (ANC count <100/ml) was significantly shorter in group B compared to group A; platelet counts >20 x 10(9) and >50 x 10(9)/l were achieved at days + 13 and + 17, respectively in group B, compared to days + 14 and + 24, respectively, in group A (P = 0.015, 0.002) patients. The transfusion requirement was reduced in group B, with 0 (0-6) RBC units and 1 (0-5) platelet unit transfused in group B vs 2 RBC (0-9) and 2 platelet units (0-8) in group A. Median days of fever, antibiotic therapy and hospital stay were reduced in group B (9.5 days vs 22). The mean cost of autotransplantation per group A patient was 23,988 Euro, compared with 18,394 Euro for a group B patient. Our study suggests that the EPO + G-CSF combination not only accelerates engraftment kinetics, but can also improve the clinical course of ASCT.

Adult↗
PubMed2006

Low doses of GM-CSF (molgramostim) and G-CSF (filgrastim) after cyclophosphamide (4 g/m2) enhance the peripheral blood progenitor cell harvest: results of two randomized studies including 120 patients.

The use of a combination of G-CSF and GM-CSF versus G-CSF alone, after cyclophosphamide (4 g/m2) was compared in two randomized phase III studies, including 120 patients. In study A, 60 patients received 5 x 2 microg/kg/day of G-CSF and GM-CSF compared to 5 mug/kg/day of G-CSF. In study B, 60 patients received 2.5 x 2 microg/kg/day G-CSF and GM-CSF compared to G-CSF alone (5 microg/kg/day). With the aim to collect at least 5 x 10(6)/kg CD34 cells in a maximum of three large volume leukapherises (LK), 123 LK were performed in study A, showing a significantly higher number of patients reaching 10 x 10(6)/kg CD34 cells (21/29 in G+GM-CSF arm vs 11/27 in G-CSF arm, P=0.00006). In study B, 109 LK were performed, with similar results (10/27 vs 15/26, P=0.003). In both the study, the total harvest of CD34 cells/kg was twofold higher in G-CSF plus GM-CSF group (18.3 x 10(6) in study A and 15.85 x 10(6) in study B) than in G-CSF group (9 x 10(6) in study A and 8.1 x 10(6) in study B), a significant difference only seen in multiple myeloma, with no significant difference in terms of mobilized myeloma cells between G-CSF and GM-CSF groups.

Adult↗
PubMed1996

Mobilization of Philadelphia-negative peripheral blood mononuclear cells in chronic myeloid leukaemia using hydroxyurea and G-CSF (filgrastim).

A relatively simple and non-toxic out-patient-based regimen for the mobilization of Philadelphia-negative (Ph-ve) mononuclear cells in chronic myeloid leukaemia (CML) was evaluated in 10 patients, nine in stable chronic phase and one in accelerated phase. They received oral hydroxyurea at a mean dose of 3.5 g/m2 daily for 7 d, followed by 300 micrograms of G-CSF daily until the last day of harvesting. In the nine chronic-phase patients the mean number of days from the end of hydroxyurea to the commencement of harvesting was 14.5 (range 10-18). The patient in accelerated phase recovered and was harvested after 6 d. The mean number of aphereses performed was 3.4. Adequate numbers of stem cells were obtained in 9/10 patients judged by our usual criteria. Side-effects were mild in comparison to published intravenous schedules. No patients lost their hair. Five (50%) patients required admission with neutropenic fever which responded to antibiotics in all cases. Four (40%) patients developed a transient rash and four (40%) experienced mild oral mucostis. This level of toxicity enabled half of the patients to be treated entirely on an out-patient basis. The harvest products were analysed for cells belonging to the leukaemic clone by conventional cytogenetics, FISH and PCR. All were PCR positive. The mean Ph positivities by cytogenetics and FISH were comparable at 18.1% and 15% respectively. Half the patients had > 98% normal metaphases. We conclude that this approach is comparable in efficacy to published intravenous regimens and significantly less toxic. It can be safely used at diagnosis before interferon therapy commences.

Administration, Oral↗
PubMed2003

Analysis of PBPC cell yields during large-volume leukapheresis of subjects with a poor mobilization response to filgrastim.

BACKGROUND: The circulating CD34 count is a reliable predictor of peripheral blood progenitor cell (PBPC) yields in subjects with a vigorous mobilization response to G-CSF, however, the value of this parameter in poor mobilizers is uncharacterized. STUDY DESIGN AND METHODS: Consecutive PBPC procedures (n = 81) with preapheresis CD34 counts less than 20 per microL (poor mobilizers) were compared with an equal number of good mobilizers (preapheresis CD34 counts > or =20/microL). G-CSF was administered at standard doses (10 microg/kg/day). RESULTS: CD34 yields correlated strongly with preapheresis CD34 counts in both good and poor mobilizers and were higher in allogeneic than autologous donors. For a standard 75-kg recipient, a CD34 cell dose of greater than 2 x 10(6) per kg was never achieved in less than two 15-L procedures if the preapheresis CD34 count was less than 8 per microL. Preapheresis WBC and MNC counts were lower in poor than in good mobilizers (28.4 vs. 43.0 and 3.25 vs. 5.01 x 10(3)/microL, respectively, p < 0.0001). Total WBC counts correlated more strongly with preapheresis CD34 counts, total CD34 yields, and CD34 yields per L processed in good mobilizers (R = 0.50, R = 0.44, and R = 0.42, respectively) than in poor mobilizers (R = 0.22, R = 0.02, and R = 0.01, respectively), whereas total MNC counts correlated more strongly with these parameters in poor (R = 0.38, R = 0.23, and R = 0.27, respectively) than in good mobilizers (R = 0.04, R = 0.13, and R = 0.16, respectively). CONCLUSION: CD34 cell yields correlate strongly with preapheresis CD34 counts. Based on this analysis, a CD34 count greater than or equal to 8 per microL is the threshold for performing PBPC collections in our institution.

Adolescent↗
PubMed2000

Transplantation potential of peripheral whole blood primed by VACOP-B chemotherapy plus filgrastim (r-metHuG-CSF) in patients with aggressive non-Hodgkin's lumphoma.

Large volumes of peripheral blood need to be processed to obtain sufficient stem cells for hematopoietic rescue after myeloablation, and more than one leukapheresis is necessary in most patients. We conceived the feasibility of harvesting sufficient numbers of hematopoietic cells from the whole blood, obtainable by venaepunctures, of patients treated with a standard dose chemotherapy regimen for high-grade non-Hodgkin's lymphoma. We evaluated the kinetics of mobilization, amount and quality of hematopoietic cells released into circulation during VACOB-B chemotherapy (which consists of a 12-week program), and G-CSF in 6 patients with aggressive non-Hodgkin's lymphoma. The median number of granulocyte-macrophage colony-forming cells (GM-CFC) x 10(3)/ml of blood (range), were 1.9 (0.3-8), and 1.16 (0.2-3.2) after the 7th and 11th weekly dose of drugs, respectively, showing an increase of 19- and 12-fold over patients' prechemotherapy values and of 53- and 33-fold over normal controls (p < 0.001). The median number of CD34+ cells x 10(3)/ml of blood (range), at the 7th and 11th cycle, was 135 (53.7-240.9) and 79.8 (69-173.5), respectively, showing an increase of 10- and 13-fold over patients prechemotherapy values (p < or = 0.04) and of 300- and 179-fold over normal controls (p < or = 0.001). Long-term culture initiating cells (LTC-IC) were released into circulation together with hematopoietic progenitors. We estimated that 1 liter of peripheral blood could yield on average 1.8 x 10(6)/kg CD34+ cells and 2 x 10(4)/kg GM-CFC with LTC-IC frequency comparable to a bone marrow harvest. These figures may be considered sufficient for hematopoietic rescue after myeloablation or hematopoietic support after high-dose chemotherapy.

Adult↗
PubMed1998

A study of filgrastim (rG-CSF) priming of etoposide/cisplatin in advanced non-small cell lung cancer.

A previous phase II study (CALGB 9132) of etoposide/cisplatin + rG-CSF in patients with advanced non-small cell lung cancer (NSCLC) showed a marked difference in the absolute neutrophil count (ANC) nadirs between courses 1 and 2. Median ANC nadirs for courses 1 and 2 were 200 and 2500, respectively, suggesting a priming effect for rG-CSF. The present study was designed to determine whether rG-CSF given prior to the first cycle of chemotherapy would decrease the severity and duration of neutropenia. Twelve patients with stage IIIB or IV NSCLC and performance status 0-1 received rG-CSF 5 microg/kg for 5 consecutive days starting 7 days before treatment with etoposide 200 mg/m2 on days 1-3 and cisplatin 35 mg/m2 on days 1-3, repeated every 3 weeks. Patients also received rG-CSF 5 microg/kg s.c. day 4 to postnadir ANC > 10,000. The median WBC nadir, ANC nadir, and platelet nadir after the first cycle of chemotherapy in the historical group (CALGB 9132) were 1300 cells/microl, 200 cells/microl, and 80,000 cells/microl, respectively. In the present study, the median WBC nadir, ANC nadir, and platelet nadir were 1300 cells/microl, 144 cells/microl, and 56,000 cells/microl, respectively. The median time for ANC to reach 10,000 cells/microl was 15 days in both the historical and the present study. For course 2, the WBC, ANC, platelet nadirs, and duration of grade 4 neutropenia were 2600, 1450, 70,000, and 0 days, respectively. This study failed to show a priming effect for rG-CSF when given in this dose and schedule.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Autologous transplantation of blood stem cells mobilized with filgrastim alone in 93 patients with malignancies: the number of CD34+ cells reinfused is the only factor predicting both granulocyte and platelet recovery.

High-dose chemotherapy (HDC) supported by autologous transplantation of blood stem cells (BSC) is used increasingly for patients with poor-risk malignancies. We report our experience with 93 consecutive patients who were mobilized with recombinant human granulocyte colony-stimulating factor (rhG-CSF) alone. They received a fixed dose of G-CSF for 5 or 6 days, and BSC were collected by leukapheresis. Aphereses were evaluated for MNC, CD34+ cells, and CFU-GM counts and cryopreserved. All patients received a conditioning regimen without TBI. Engraftment was assessed as the first of 2 consecutive days on which patients achieved 0.5 and 1 x 10(9)/L neutrophils and an unsupported platelet count of 25 x 10(9)/L. Multivariate analysis was performed to study patients and graft characteristics that could influence reconstitution. The G-CSF priming regimen was well tolerated and allowed collection of BSC for all patients, 66% of them achieving >3 x 10(6)/kg CD34+ cells, and 86% achieving >10 x 10(4) CFU-GM/kg. The numbers of collected CD34 and CFU-GM cells were highly correlated. The number of courses of chemotherapy prior to collection, a diagnosis of breast cancer, the use of rhG-CSF posttransplant, and the numbers of CFU-GM and CD34+ cells reinfused were correlated with hematologic recovery. In a multivariate analysis, however, the number of CD34+ cells was the only factor independently influencing both granulocyte and platelet recovery. Patients who received at least 3 x 10(6)/kg CD34+ cells achieved granulocyte reconstitution on day 11 after reinfusion (range 8-15) and an unsupported platelet count of 25 x 10(9)/l on day 14 (range 12-180), significantly earlier than patients who received fewer cells (p < 0.001). In addition, G-CSF administration postreinfusion independently enhanced granulocyte reconstitution but not platelet recovery. In conclusion, CD34+ cell number appears to be the only factor predicting both granulocyte and platelet reconstitution. Based on this study, the collection of a minimal number of 3 x 10(6)/kg CD34+ cells appears desirable.

Adolescent↗