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PubMed1998

Filgrastim restores interleukin-2 production in blood from patients with advanced human immunodeficiency virus infection.

Filgrastim induces lymphocytosis, including all T cell subsets, and increased ex vivo interleukin (IL)-2 release as well as lymphocyte proliferation. Since Filgrastim is increasingly used in patients with human immunodeficiency virus (HIV) infection, the effect of Filgrastim on ex vivo cytokine production was determined. Whole blood from 8 healthy volunteers, 5 high-risk volunteers, and 31 HIV-infected outpatients was assayed for cytokine production in response to endotoxin (LPS) or staphylococcal enterotoxin B (SEB) in the presence or absence of 100 ng/mL Filgrastim. LPS-inducible blood cytokine release of HIV-infected patients was not different from that of normal or high-risk volunteers. The suppressive effect of Filgrastim on LPS-inducible blood tumor necrosis factor-alpha and interferon-gamma formation in normal volunteers was not found in HIV-infected patients. Patients with advanced HIV infection showed reduced IL-2 and IL-4 release in the presence of SEB. In the presence of Filgrastim, IL-2 production was partially restored.

Adult↗
PubMed1996

Prophylactic filgrastim (G-CSF) during mitomycin-C, mitoxantrone, and methotrexate (MMM) treatment for metastatic breast cancer. A randomized study.

Patients with metastatic breast cancer were randomly assigned to receive as second-line chemotherapy either MMM (mitomycin 8 mg/m2 day 1; mitoxantrone 8 mg/m2 days 1 and 22; methotrexate 35 mg/m2 days 1 and 22) alone or in combination with filgrastim (5 micrograms/kg s.c. days 4-17, 24-37). The courses were repeated every 42 days for a maximum of six courses. Thirty-one patients are evaluable for safety and efficacy. The 16 patients in the filgrastim arm received a total of 42 cycles compared with 34 cycles in the 15 control patients. Tumor responses were few in both patient groups (one partial response in the filgrastim group and two partial responses in control group). Nevertheless, a difference in survival was seen (filgrastim median 10.7 months, control median 6.5 months; p = 0.02 log rank). The treatment was well tolerated. Doses were reduced six times in the filgrastim arm and eleven times in the control arm. Grade IV neutropenia was seen in four patients in the filgrastim arm and in twelve patients in the control arm. The observed survival benefit needs to be confirmed in a larger patient group.

Adult↗
PubMed1998

Dose escalation study of carboplatin and cyclophosphamide with filgrastim support: a phase I study.

This clinical trial was designed to explore dose escalation of carboplatin and cyclophosphamide when supported with filgrastim. Twenty-seven patients who had advanced solid tumors received up to six cycles of treatment; a total of 92 cycles of chemotherapy were delivered. Two control groups received standard-dose carboplatin (300 mg/m2) and cyclophosphamide (600 mg/m2), with and without filgrastim. Subsequently, the doses of both carboplatin and cyclophosphamide were increased simultaneously by 50% of the standard dose in sequential cohorts. Doses of up to 2.5 times the standard dose were explored. A final dose of carboplatin, 600 mg/m2, and cyclophosphamide, 1,500 mg/m2, was tested in 4 patients. The duration of neutropenia was brief, even at the highest dose levels. The mean duration of grade 3 or 4 neutropenia was 5.8 days at standard dose without filgrastim and 5.4 days at 2.5 times standard dose with filgrastim. More severe neutropenia was more prolonged at higher doses but remained brief in duration. The mean duration of neutropenia of less than 100 x 10(6)/l was 0.4 days at standard dose without filgrastim and 1.3 days at 2.5 times standard dose. There was no evidence of cumulative neutropenia over repeated cycles of treatment. In contrast, thrombocytopenia was both dose limiting and cumulative. The mean duration of grade 3 or 4 thrombocytopenia was 1.6 days at standard dose and 9.6 days at 2.5 times standard dose. An average of 2.3 platelet transfusions per cycle of treatment was required at the highest dose. Thrombocytopenia was worse with repetitive cycles of therapy. The mean duration of grade 3 or 4 thrombocytopenia was 2.2 days after the first cycle of chemotherapy and 7.8 days after cycle four. The maximum tolerated dose, as defined prospectively, was not reached but further dose escalation was not thought to be warranted because of the severity of thrombocytopenia. When supported with filgrastim, carboplatin and cyclophosphamide can be administered safely with substantially increased dose and acceptable toxicity.

Adolescent↗
PubMed2005

Once-per-cycle pegfilgrastim versus daily filgrastim in pediatric patients with Ewing sarcoma.

The use of the recombinant human granulocyte colony-stimulating factor filgrastim to shorten the duration of severe neutropenia after cytotoxic chemotherapy has become an integral part of supportive care. However, due to its short serum half-life, filgrastim must be injected daily. Pegfilgrastim, a new long-lasting form of filgrastim administrated once per cycle, has been shown in adults to be as effective in reducing the duration of severe neutropenia as daily filgrastim. The aim of this study was to evaluate the effects of pegfilgrastim in pediatric patients. Five children with Ewing sarcoma were alternately treated with a single 100 microg/kg pegfilgrastim dose or daily doses of 10 microg/kg Filgrastim after a total number of 58 chemotherapy cycles. Pegfilgrastim was well tolerated. The duration of severe neutropenia and the incidence of febrile neutropenia after pegfilgrastim and filgrastim were comparable. By using pegfilgrastim, the number of subcutaneous injections could be reduced to one single injection per cycle.

Adolescent↗
PubMed2001

Controlled trial of filgrastim for acceleration of neutrophil recovery after allogeneic blood stem cell transplantation from human leukocyte antigen-matched related donors.

The rapid recovery of hematopoiesis after allogeneic blood stem cell transplantation has been attributed to the quality and quantity of hematopoietic progenitors in the blood stem cell grafts from filgrastim-stimulated donors. To determine whether further stimulation with filgrastim after transplantation would affect hematopoietic recovery, a prospective, randomized, controlled study was performed. Forty-two adult recipients of allogeneic blood stem cells from human leukocyte antigen-matched related donors were randomized to receive 10 microg/kg per day filgrastim subcutaneously from day 1 through neutrophil recovery or no growth factor support after transplantation. There was no significant difference between the 2 groups in the number of CD34(+) cells infused (median, 4.8 vs 4.3 x 10(6)/kg). Graft-versus-host (GVHD) disease prophylaxis consisted of tacrolimus and steroids for 9 patients and tacrolimus and minimethotrexate for 33 patients. The group receiving filgrastim had a shorter time to neutrophil levels greater than 0.5 x 10(9)/L (day 12 vs day 15, P =.002) and to neutrophil levels greater than 1.0 x 10(9)/L (day 12 vs day 16, P =.01). The filgrastim group also had a trend for earlier discharge (day 16 vs 20, P =.05). There was no significant difference between the groups in time to platelet recovery, number of transfusions, regimen-related toxicity, infection, incidence of GVHD, relapse, survival, or hospital charges. It can be concluded that the administration of filgrastim after allogeneic blood stem cell transplantation shortens the time to neutrophil recovery. (Blood. 2001;97:3405-3410)

Adolescent↗
PubMed2003

Comparison of lenograstim and filgrastim on haematological effects after autologous peripheral blood stem cell transplantation with high-dose chemotherapy.

OBJECTIVE: To compare the efficacy of lenograstim and filgrastim on haematological recovery following an autologous peripheral blood stem cell transplantation (PBSCT) with high-dose chemotherapy. METHODS: A retrospective case-controlled study. RESULTS: Absolute neutrophil count (ANC) recovery above 0.5 x 10(9)/l and white blood cell (WBC) recovery above 4 x 10(9)/l for 3 consecutive days was achieved earlier with filgrastim than with lenograstim ((13.2 +/- 8.0 vs 19.0 +/- 10.0 days, p = 0.004), (16.9 +/- 9.7 vs 29.9 +/- 16.6 days, p = 0.001), respectively). The platelet recovery above 20 x 10(9)/l was also achieved earlier with filgrastim than with lenograstim (19.5 +/- 11.6 vs 27.2 +/- 13.8 days, p = 0.006). Furthermore, filgrastim-treated patients received fewer days of granulocyte colony simulating factor (G-CSF) administration (12.5 +/- 7.0 vs 18.6 +/- 8.5 days, p = 0.001) and spent less time in hospital (23.7 +/- 10.9 vs 32.0 +/- 17.6 days, p = 0.009). Duration of antibiotic administration was also significantly shorter in the filgrastim group (13.6 +/- 7.6 vs 29.1 +/- 19.8 days, p = 0.001). CONCLUSION: In patients undergoing PBSCT following high-dose chemotherapy, filgrastim significantly reduced the duration of neutropenia, thrombocytopenia and days of G-CSF administration, and led to earlier hospital discharge compared with lenograstim.

Adjuvants, Immunologic↗
PubMed1997

Randomized trial showing equivalent efficacy of filgrastim 5 micrograms/kg/d and 10 micrograms/kg/d following high-dose chemotherapy and autologous bone marrow transplantation in high-risk lymphomas.

PURPOSE: To evaluate the effect of two filgrastim dosages after autologous bone marrow transplantation (ABMT) in patients with Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: Eighty-six patients were enrolled onto a multicenter, randomized, open-label study. The study compared the efficacy and safety of two different doses of filgrastim, 5-microgram/kg/d subcutaneous (SC) bolus injection and 10-microgram/kg/d SC continuous infusion, starting on day 1 following ABMT. RESULTS: Both patient groups were well matched in terms of demography and disease. The results showed no statistical difference in the median time to reach an absolute neutrophil count (ANC) of 0.5 x 10(9)/L (11 days; P = .685) and no difference in the median duration of neutropenia (10 v 11 days, respectively; P = .567) between either dose of filgrastim. The incidence and duration of fever and neutropenic fever were the same in both groups. The number and mean duration of clinically and documented infections, duration of intravenous (IV) antibiotics, time to discharge from hospital, and tumor response also were similar in both groups. CONCLUSION: This study demonstrates that a dose of filgrastim 5 micrograms/kg/d administered as a daily SC bolus injection has a similar efficacy and safety profile compared with the 10-microgram/kg/d dose administered as a SC continuous infusion. The lower dose of filgrastim has potential cost-saving implications in terms of both the dose of drug administered and the ease of administration. Based on these findings, the recommended dose of filgrastim after ABMT should be 5 micrograms/kg/d.

Adolescent↗
PubMed2003

Phase III trial of paclitaxel at two dose levels, the higher dose accompanied by filgrastim at two dose levels in platinum-pretreated epithelial ovarian cancer: an intergroup study.

PURPOSE: To determine if increasing the dose of paclitaxel increases the probability of clinical response, progression-free survival, or overall survival in women who have persistent or recurrent ovarian cancer, and whether doubling the dose of prophylactic filgrastim accompanying the higher paclitaxel dose decreases the frequency of neutropenic fever. PATIENTS AND METHODS: Consenting patients with persistent, recurrent, or progressing ovarian cancer, despite first-line platinum therapy (but no prior taxane), were randomly assigned to paclitaxel 135 mg/m2, 175 mg/m2, or 250 mg/m2 over 24 hours every 3 weeks. Patients receiving paclitaxel 250 mg/m2 were also randomly assigned to 5 or 10 microg/kg of filgrastim per day subcutaneously. RESULTS: Accession to the paclitaxel 135-mg/m2 arm was closed early. Among the 271 patients on the other regimens with measurable disease, partial and complete response on paclitaxel 250 mg/m2 (36%) was significantly higher than on 175 mg/m2 (27%, P =.027). This difference was more evident among patients who never responded to prior platinum. However, progression-free and overall survival results were similar. The median durations of overall survival were 13.1 and 12.3 months for paclitaxel 175 mg/m2 and 250 mg/m2, respectively. Thrombocytopenia, neuropathy, and myalgia were greater with paclitaxel 250 mg/m2 (P <.05). The incidence of neutropenic fever after the first cycle of paclitaxel 250 mg/m2 was 19% and 18% on the 5-microg/kg and 10-microg/kg filgrastim dose, respectively (22% for paclitaxel 175 mg/m2 without filgrastim). CONCLUSION: Paclitaxel exhibits a dose effect with regard to response rate, but there is more toxicity and no survival benefit to justify paclitaxel 250 mg/m2 plus filgrastim. Doubling the filgrastim dose from 5 to 10 microg/kg did not reduce the probability of neutropenic fever after high-dose paclitaxel.

Adult↗
PubMed2002

Economic analysis of filgrastim use for patients with acute myeloid leukaemia in the UK: a comparison of collection methods of resource use data.

BACKGROUND: A clinical trial of patients with de novo acute myeloid leukaemia (AML) showed that haematopoietic support with filgrastim (granulocyte colony-stimulating factor, G-CSF) following induction and consolidation chemotherapy accelerated recovery from neutropenia. The clinical benefits included reductions in infections, anti-infective therapy and length of hospital stay. OBJECTIVE: The objective of this economic analysis is 2-fold. First, it aims to determine if the observed clinical benefits from the use of filgrastim would lead to cost savings from the perspective of a healthcare institution in the UK. Second, the analysis compares the results of two methods on collection of resource use data. DESIGN: A retrospective cost-minimisation analysis was undertaken based on the clinical results of all UK patients enrolled in the trial. Two cost models were developed: a model based only on the medical resource use collected in the case report forms (the CRF model); and a model based on all medical resources collected from patient medical files (the PF Model). Treatment costs of AML between filgrastim and the placebo arm were compared for the first induction cycle as well as the first induction and the first consolidation cycles combined. Results from the two models were compared. SETTING AND PATIENTS: The CRF model was applied to two samples of patients: all UK patients (n = 82) and patients enrolled at one centre [the Manchester Royal Infirmary (MRI) (n = 30)], whereas the PF model was applied to the MRI patient sample only. RESULTS: For all UK patients, using the CRF model, the filgrastim-treated arm produced cost savings of 747 pounds sterling (9.0%) and 2135 pounds sterling (14.4%) [1998 values] per patient in the first induction cycle and in the induction and consolidation cycles combined, respectively. For the patients at MRI the CRF model resulted in cost savings with filgrastim of 177 pounds sterling (2.2%) and 414 pounds sterling (3.2%) per patient respectively. Using the PF model the savings at MRI were 910 pounds sterling (8.6%) and 1285 pounds sterling (8.0%) per patient, respectively. CONCLUSION: Use of filgrastim in the treatment of AML in the UK may result in net cost savings. A retrospective analysis using total resources obtained through patient files produced higher cost savings estimates than that obtained by resources noted in the CRFs. The models based on PF resource data may be more reliable because they are more comprehensive. However, the cost estimates in this study may have been impacted by sample size, site characteristics, disease and treatment settings. Therefore, further evaluation on the methods for collecting resource use data in larger, multicentred studies is warranted.

Adult↗
PubMed1994

Filgrastim in patients with chemotherapy-induced febrile neutropenia. A double-blind, placebo-controlled trial.

OBJECTIVE: To determine if filgrastim (recombinant human methionyl granulocyte colony-stimulating factor) used in addition to standard inpatient antibiotic therapy accelerated recovery from infection associated with chemotherapy-induced neutropenia. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Hematology and oncology wards of four teaching hospitals. PATIENTS: 218 patients with cancer who had fever (temperature > 38.2 degrees C) and neutropenia (neutrophil count < 1.0 x 10(9)/L) after chemotherapy. INTERVENTION: Patients were randomly assigned to receive filgrastim (12 micrograms/kg of body weight per day) (n = 109) or placebo (n = 107) beginning within 12 hours of empiric therapy with tobramycin and piperacillin. Patients received treatment and remained in the study until the neutrophil count was greater than 0.5 x 10(9)/L and until 4 days without fever (temperature < 37.5 degrees C) had elapsed. MEASUREMENTS: Days of neutropenia and fever and days in the study (hospitalization); time to resolution of fever and febrile neutropenia; and frequency of the use of alternative antibiotics. RESULTS: Compared with placebo, filgrastim reduced the median number of days of neutropenia (3.0 compared with 4.0 days of a neutrophil count of < 0.5 x 10(9)/L; P = 0.005) and the time to resolution of febrile neutropenia (5.0 compared with 6.0 days; P = 0.01) but not days of fever (3.0 days for both groups). The frequency of the use of alternative antibiotics was similar in the two groups (46% compared with 41%; P = 0.48). The median number of days patients were hospitalized while on study was the same (8.0 days; P = 0.09); however, filgrastim decreased the risk for prolonged hospitalization (> 11 days, 4th quartile) by half (relative risk, 2.1 [95% CI, 1.1 to 4.1]; P = 0.02). In exploratory subset analyses, filgrastim appeared to provide the greatest benefit in patients with documented infection and in patients presenting with neutrophil counts of less than 0.1 x 10(9)/L. CONCLUSIONS: Filgrastim treatment used with antibiotics at the onset of febrile neutropenia in patients with cancer who have received chemotherapy accelerated neutrophil recovery and shortened the duration of febrile neutropenia.

Adolescent↗
PubMed1999

Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double-blind, placebo-controlled trial.

We wished to determine if filgrastim administration to chemotherapy/radiation therapy-naive patients receiving external-beam irradiation for head-and-neck malignancies would reduce the incidence and severity of oral/oropharyngeal mucositis. Patients were randomized to receive subcutaneous injections of either filgrastim or placebo beginning on day 1 of radiation and continuing daily throughout treatment. Study medication was titrated to keep the neutrophil count between 10 x 10(9) and 30 x 10(9)/l. The left and right buccal mucosa, hard palate, and posterior pharyngeal wall were scored weekly, by a blinded evaluator using two different scales, and the most severe score per week was used in data analysis. Fourteen of a planned 54 patients were randomized (8 filgrastim, 6 placebo), and were evaluable for a planned interim analysis. No statistically significant between-group differences were seen in mean worst scores across time using repeated measures analysis of variance (Hickey, p = 0.231; WHO, p= 0.288). At almost all timepoints, however, the worst mean scores were lower in patients treated with filgrastim compared with those in patients treated with placebo, and the number of severe (i.e., grade 3) mucositis scores was significantly lower in the filgrastim-treated group. Filgrastim may decrease the severity of radiation-induced oral/oropharyngeal mucositis.

Adolescent↗
PubMed1999

Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy.

Mucositis, the inflammation and necrosis of mucosal membranes, is a serious and debilitating consequence of many cancer therapies. We were interested in the potential role of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor, r-metHuG-CSF) in the reduction of mucositis. Patients with newly diagnosed small-cell lung cancer (SCLC) were treated with CAE chemotherapy (cyclophosphamide, doxorubicin, and etoposide) and placebo or filgrastim. If patients had an episode of febrile neutropenia, they received unblinded filgrastim in subsequent CAE cycles. Oral mucositis was considered to have occurred if a patient reported any clinical sign or symptom of oral mucositis with or without oral candidiasis. Oral mucositis was analyzed using the unadjusted chi-square test, and time to first episode of mucositis was analyzed using the stratified log-rank test as well as the Cox proportional hazards regression model. During cycle 1, placebo-treated patients had more episodes of mucositis (47%) compared with those patients randomized to filgrastim (28%). Across all cycles of treatment, 70% of placebo-treated patients experienced mucositis, compared with 53% of patients randomized to filgrastim. A significant reduction in the incidence of chemotherapy-related oral mucositis occurred across multiple cycles of treatment in patients treated with filgrastim.

Adult↗
PubMed2002

Cost analysis of regular and filgrastim treatment in patients with refractory chronic rhinosinusitis.

In this double blind randomized placebo controlled clinical trial of filgrastim in chronic sinusitus, we analyzed costs of a 24-week interval in which filgrastim was administered. Since we hypothesized that the scheduled preventive visits within the trial might cause savings as compared to the regular situation in which these patients have a strong tendency to visit the outpatient clinic immediately in case of complications, direct medical costs within the trial were also compared to costs of regular treatment. The difference in costs between both trial groups was driven by the filgrastim costs (Euro 5108). If filgrastim costs were left out of consideration, no significant difference in direct medical costs remained between the filgrastim and placebo groups (Euro 2904 and Euro 2765, respectively). Indirect medical costs also showed no significant differences. Within a regular situation, costs of a 24-week interval were Euro 896. As filgrastim treatment had already been shown not to improve the quality of life, its cost-effectiveness in these patients can only be favourable in case of major clinical improvements. Furthermore, scheduled preventive visits in chronic sinusitis patients appear not to cause savings as compared to the situation in which patients are only seen in case of recurrences.

Adult↗
PubMed1995

A pilot study of the biologic and therapeutic effects of granulocyte colony-stimulating factor (filgrastim) in patients with acute myelogenous leukemia.

In a carefully monitored pilot study, the in vivo biologic effects of filgrastim were investigated in eight patients with relapsed/refractory acute myelogenous leukemia. Within each patient, filgrastim was administered as a single agent prior to any chemotherapy in escalating doses of 0.12-6.0 micrograms/kg/day as a continuous intravenous infusion. The dose was increased every 14 days until an ANC of > or = 2500/mm3 had been achieved or there was evidence of proliferation of the leukemia. In patients who demonstrated growth of the leukemic clone, cytosine arabinoside was initiated at 200 mg/m2/day for 5 days. Through-out the course of therapy, the effects of filgrastim on maturation and proliferation were assessed by in vitro studies of bone marrow aspirates. Three patients demonstrated a sustained increase in ANC; one achieved a partial remission and remained on therapy for 31 weeks. Two of the three responding patients had hypocellular marrows at the time of initiating filgrastim and demonstrated a low but normal pattern of growth in CFU-GM assay early in the treatment course. This suggested that these two characteristics may define an environment in which filgrastim can induce a growth advantage for the normal residual hematopoietic elements. In this study of selected patients, filgrastim appeared safe.

Adult↗
PubMed1994

[Use of filgrastim (RHU G-CSF) in supplemental treatment of non Hodgkin's lymphoma (NHL) in children].

Clinical application of glycoproteins stimulating the growth (G-CSF), differentiation and activity of the cells of granulocyte line has become a landmark in the treatment of patients with neutropenia. It has been proved that filgrastim (rHU G-CSF) applied after intensive chemotherapy shortens the duration of neutropenia and decreases the frequency of occurrence of infections. The paper discusses the efficiency and tolerance of filgrastim in children treated for NHL. Filgrastim was applied in children with NHL T cell and B cell treated according to BFM 86 protocols. It was given in a dose of 5 micrograms/kg daily i.v. The duration of therapy ranged from 5-20 days. Altogether 47 cycles were performed. 25 cycles were performed in 12 children during granulocytopenia (< 1 x 10(9)/l). The median time of neutropenia recovery, the frequency of severe infection and chemotherapy retardation were significantly lower in the examined than in the control group (p < 0.05). In 6 children 22 courses of filgrastim were given prophylactically after the cycles of intensive chemotherapy of NHL. Only during two courses due to neutropenia the chemotherapy retardation was necessary. Toleration of filgrastim was good. Application of filgrastim right after the intensive chemotherapy in children with NHL has considerably improved persistent realization of treatment programmes. Tolerance of the drug was good.

Adolescent↗
PubMed1994

Compatibility of filgrastim with selected drugs during simulated Y-site administration.

The compatibility of filgrastim with selected drugs during simulated Y-site injection was studied. Five-milliliter samples of filgrastim 30 micrograms/mL in 5% dextrose injection were combined with 5-mL samples of solutions of each of 97 other drugs in 5% dextrose injection at clinically used concentrations at 22 degrees C. Immediately after and one and four hours after the samples were combined, visual examinations were performed in fluorescent light with the unaided eye and with a high-intensity monodirectional light (Tyndall beam) to enhance the visualization of small particles and low-level turbidity. The turbidity of each drug combination was measured as well. Combinations yielding inconclusive results were subjected to particle sizing and counting. Most of the drugs tested were compatible with filgrastim 30 micrograms/mL during the observation period. However, 22 drugs showed various incompatibilities with filgrastim, including filament formation, particulate formation and precipitation, and color change. Filgrastim 30 micrograms/mL in 5% dextrose injection was compatible with 75 drugs for up to four hours at 22 degrees C; 22 drugs were not compatible with filgrastim.

Chemical Precipitation↗
PubMed1992

Effect of peripheral-blood progenitor cells mobilised by filgrastim (G-CSF) on platelet recovery after high-dose chemotherapy.

The haemopoietic growth factor granulocyte colony-stimulating factor (G-CSF; filgrastim) substantially shortens the period of severe neutropenia that follows high-dose chemotherapy and autologous bone-marrow infusion by stimulating granulopoiesis. Filgrastim also increases numbers of circulating progenitor cells. We have studied the ability of filgrastim to mobilise peripheral-blood progenitor cells and assessed their efficacy when infused after chemotherapy on recovery of neutrophil and platelet counts. 17 patients with non-myeloid malignant disorders received filgrastim (12 micrograms/kg daily for 6 days) by continuous subcutaneous infusion. Numbers of granulocyte-macrophage progenitors in peripheral blood increased a median of 58-fold over pretreatment values, and numbers of erythroid progenitors increased a median of 24-fold. Three leucapheresis procedures collected a mean total of 33 (SEM 5.7) x 10(4) granulocyte-macrophage progenitors per kg body weight. After high-dose chemotherapy in 14 of the patients (busulphan and cyclophosphamide), these cells were used to augment autologous bone-marrow rescue and post-transplant filgrastim treatment. Platelet recovery was significantly faster in these patients than in controls who received the same treatment apart from the infusion of peripheral-blood progenitors; the platelet count reached 50 x 10(9)/l a median of 15 days after infusion of haemopoietic cells in the study patients compared with 39 days in controls (p = 0.0006). The accelerated neutrophil recovery associated with filgrastim treatment after chemotherapy was maintained. This method may be widely applicable to aid both neutrophil and platelet recovery after high-dose chemotherapy; it will allow investigation of peripheral-blood progenitor-cell allotransplantation.

Adolescent↗
PubMed1995

Optimizing dose and scheduling of filgrastim (granulocyte colony-stimulating factor) for mobilization and collection of peripheral blood progenitor cells in normal volunteers.

To define an optimal regimen for mobilizing and collecting peripheral blood progenitor cells (PBPC) for use in allogeneic transplantation, we evaluated the kinetics of mobilization by filgrastim (recombinant met-human granulocyte colony-stimulating factor [r-metHuG-CSF]) in normal volunteers. Filgrastim was injected subcutaneously for up to 10 days at a dose of 3 (n = 10), 5 (n = 5), or 10 micrograms/kg/d (n = 15). A subset of volunteers from each dose cohort underwent a 7L leukapheresis on study day 6 (after 5 days of filgrastim). Granulocyte-macrophage colony-forming cell (GM-CFC) numbers in the blood were maximal after 5 days of filgrastim; a broader peak was evident for CD34+ cells between days 4 and 6. The 95% confidence intervals (CI) for mean number of PBPC per milliliter of blood in the three dose cohorts overlapped on each study day. However, on the peak day, CD34+ cells were significantly higher in the 10 micrograms/kg/d cohort than in a pool of the 3 and 5 micrograms/kg/d cohorts. Mobilization was not significantly influenced by volunteer age or sex. Leukapheresis products obtained at the 10 micrograms/kg/d dose level contained a median GM-CFC number of 93 x 10(4)/kg (range, 50 x 10(4)/kg to 172 x 10(4)/kg). Collections from volunteers receiving lower doses of filgrastim contained a median GM-CFC number of 36 x 10(4)/kg (range, 5 x 10(4)/kg to 204 x 10(4)/kg). The measurement of CD34+ cells per milliliter of blood on the day of leukapheresis predicted the total yield of PBPC in the leukapheresis product (r = .87, P < .0001). Assuming a minimum GM-CFC requirement of 50 x 10(4)/kg (based on our experience with autologous PBPC transplantation), all seven leukapheresis products obtained at the 10 micrograms/kg/d dose level were potentially sufficient for allogeneic transplantation purposes. We conclude that in normal donors, filgrastim 10 micrograms/kg/d for 5 days with a single leukapheresis on the following day is a highly effective regimen for PBPC mobilization and collection. Further studies are required to determine whether PBPC collected with this regimen reliably produce rapid and sustained engraftment in allogeneic recipients.

Antigens, CD34↗