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PubMed2001

Effect of prechemotherapy filgrastim on the bone marrow toxicity of topotecan.

PURPOSE: To investigate the efficacy and safety of single-dose filgrastim administered 24 hours prior to chemotherapy in the prevention of topotecan-related myeloid suppression. METHODS: No medication was given to 21 rats in group 1; 1.5 mg/m2/day topotecan was administered intraperitoneally for five days every three weeks to 21 rats in group II; a single dose of 5 microg/kg filgrastim was injected intraperitoneally 24 hours before the intraperitoneal administration of the same dose of topotecan to 21 rats in group III. After completion of six cycles of chemotherapy. the rats were decapitated and blood samples were immediately collected into citrated tubes for complete blood counts. RESULTS: White blood cell and lymphocyte counts in the control and the filgrastim + topotecan groups were similar (p > 0.05) and significantly higher than the counts in the topotecan group (p < 0.05). There was no difference in means of neutrophil, monocyte, eosinophil, basophil and erythrocyte counts among the groups (p > 0.05). CONCLUSION: Filgrastim administration prior to chemotherapy seems to be beneficial and further investigations are needed.

Animals↗
PubMedDate not supplied

A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer.

This combined, retrospective analysis compared once-per-chemotherapy-cycle pegfilgrastim with daily Filgrastim in breast cancer patients undergoing myelosuppressive chemotherapy enrolled in two similarly designed, randomized, double-blind, pivotal trials. On day 2 of each chemotherapy cycle, a single subcutaneous (SC) injection of pegfilgrastim [either 6 mg (n=77) or 100 microg/kg (n=149)] was administered, or daily Filgrastim SC injections (5 microg/kg/day; n=222) were initiated and continued until either absolute neutrophil count (ANC) > or =10 x 10(9)/l after the expected nadir or for up to 14 days, whichever occurred first. Individually, each of these trials demonstrated that a single pegfilgrastim injection per cycle is as effective at reducing the duration of severe neutropenia as daily injections of Filgrastim. Clinical efficacy data from the two trials were combined for analysis (n=448). The risk of febrile neutropenia (FN; absolute neutrophil count <0.5 x 10(9)/l with fever > or =38.2 degrees C) was significantly lower [11% vs 19%, respectively; relative risk = 0.56 (95% confidence interval: 0.35, 0.89)] in patients receiving pegfilgrastim than for those receiving Filgrastim. Trends towards lower risks of hospitalization and intravenous anti-infective use were also observed. These observations were consistent irrespective of risk factors, including age, disease stage, performance status and prior treatment. Pegfilgrastim may offer patients more effective protection against neutropenic complications of chemotherapy with fewer injections and less disruption to their lives.

Aged↗
PubMed2005

Effects of filgrastim on granulopoietic cells of mice pretreated with methotrexate.

We have evaluated the effect of filgrastim on proliferation and differentiation activity of granulopoietic cells in mice pretreated with methotrexate. Filgrastim was injected daily, from day 8 to 28 after cytotoxic agent administration. The granulopoiesis changes were measured by assessment of GM-CFU cells content, marrow and spleen granuloid cells pool as well as circulating neutrophils. In MTX pretreated mice, bone marrow GM-CFU oscillating values were higher than normal values, but these changes were not followed by high proliferative activity in granuloid precursor cell compartment. After MTX treatment, filgrastim administration was unable to stimulate marrow granulopoiesis as observed in normal mice. In the spleen, MTX led to dramatic changes in the proliferative activity of GM-CFU cells, but did not result in spleen granuloid cell changes. However, filgrastim treatment induced a spleen granuloid amplification, similar to the changes observed in circulating neutrophils values. We suggest that these findings can be explained by inhibition of differentiation of marrow GM-CFU cells into the more mature granulopoietic cells and/or by an inhibited proliferative activity of marrow granuloid cells. They can be also explained in terms of an unfavorable marrow microenvironment for granulopoiesis, contrary to a supportive spleen microenvironment.

Animals↗
PubMed1994

Phase II study of autologous filgrastim (G-CSF)-mobilized peripheral blood progenitor cells to restore hemopoiesis after high-dose chemotherapy for lymphoid malignancies.

The hemopoietic growth factor filgrastim (r-metHu G-CSF) stimulates granulopoiesis after autologous BMT and can also be used as a peripheral blood progenitor cell (PBPC)-mobilizing agent. Rapid platelet recovery follows the addition of filgrastim-mobilized PBPC to autologous BMT. We have now studied 29 adults with malignant lymphoma, Hodgkin's disease or ALL to assess the ability of filgrastim-mobilized PBPC to rapidly and durably restore hemopoiesis without bone marrow (BM) infusion. Patients with a high yield of PBPC from three leukaphereses, defined as > 30 x 10(4)/kg GM-CFC, were eligible for PBPC transplant without BM. Patients with a low yield of GM-CFC received both PBPC and BM infusion. After filgrastim therapy 12 or 24 micrograms/kg/day by continuous sc infusion for 6 or 7 days, a high yield was obtained in 11 of 29 patients. Kinetics of recovery of both the platelet and neutrophil counts were more rapid in the high yield group than in the low yield group. The platelet count recovered to > 20 x 10(9)/l at a median of 9 days, to > 50 x 10(9)/l at 11 days and the neutrophil count to > 0.5 x 10(9)/l at 9 days in the high yield group compared with 12 days, 37 days and 10 days, respectively, in the low yield group (p = 0.028, p < 0.001 and p = 0.027). Fewer platelet transfusions were required in the high yield group (median 11 vs 29.5 units, p = 0.021).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1993

A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (filgrastim) for treatment of severe chronic neutropenia.

Patients with idiopathic, cyclic, and congenital neutropenia have recurrent severe bacterial infections. One hundred twenty-three patients with recurrent infections and severe chronic neutropenia (absolute neutrophil count < 0.5 x 10(9)/L) due to these diseases were enrolled in this multicenter phase III trial. They were randomized to either immediately beginning recombinant human granulocyte colony-stimulating factor (filgrastim) (3.45 to 11.50 micrograms/kg/d, subcutaneously) or entering a 4-month observation period followed by filgrastim administration. Blood neutrophil counts, bone marrow (BM) cell histology, and incidence and duration of infection-related events were monitored. Of the 123 patients enrolled, 120 received filgrastim. On therapy, 108 patients had a median absolute neutrophil count of > or = 1.5 x 10(9)/L. Examination of BM aspirates showed increased proportions of maturing neutrophils. Infection-related events were significantly decreased (P < .05) with approximately 50% reduction in the incidence and duration of infection-related events and almost 70% reduction in duration of antibiotic use. Asymptomatic splenic enlargement occurred frequently; adverse events frequently reported were bone pain, headache, and rash, which were generally mild and easily manageable. These data indicate that treatment of patients with severe chronic neutropenia with filgrastim results in a stimulation of BM production and maturation of neutrophils, an increase in circulating neutrophils, and a reduction in infection-related events.

Adult↗
PubMedDate not supplied

Effect of plasma TNF-alpha on filgrastim-stimulated hematopoiesis in mice and humans.

STUDY OBJECTIVE: To delineate possible explanations for a nonmonotone hematopoiesis, dose-response curve with filgrastim therapy after high-dose chemotherapy DESIGN: Sequential two-phase study. SETTINGS: University teaching hospital and basic pharmaceutical sciences laboratory. SUBJECTS: Thirty-nine patients with breast cancer or melanoma and 15 normal CF-1 male mice. INTERVENTIONS: Serial blood samples were obtained from patients after high-dose chemotherapy to evaluate hematopoiesis and tumor necrosis factor-alpha (TNF-alpha) concentrations. Murine hematopoiesis was induced by filgrastim with or without coadministration of lipopolysaccharide. MEASUREMENTS AND MAIN RESULTS: Detection of plasma TNF-alpha in patients corresponded to substantially slower recovery of granulocytes, erythrocytes, and platelets, and was directly proportional to the prescribed dosage of filgrastim. Lipopolysaccharide stimulated the secretion of TNF-alpha in mice and totally aberrated filgrastim-induced granulopoiesis. CONCLUSIONS: This in vivo evidence suggests that regulatory pathways involving endogenous cytokines may override the effect of recombinant cytokines.

Adult↗
PubMed1995

Adjuvant treatment of high-risk breast cancer using multicycle high-dose chemotherapy and filgrastim-mobilized peripheral blood progenitor cells.

Women with primary breast cancer associated with extensive axillary node involvement or large primary tumors have a very poor prognosis despite treatment with standard-dose adjuvant chemotherapy. In an attempt to improve the outlook of these patients, we investigated the safety and feasibility of delivering three cycles of high-dose epirubicin and cyclophosphamide supported with filgrastim-mobilized peripheral blood progenitor cells (PBPC). Fifteen previously untreated women, median age 50 (range, 30-58) years, with poor prognosis early stage breast cancer received filgrastim (12 microgram/kg daily for 6 days) prior to chemotherapy to mobilize progenitor cells. Patients were then given three cycles of epirubicin (200 mg/m2) and cyclophosphamide (4 g/m2) at planned 28-day intervals, each followed by infusion of one third of the PBPC collected and daily administration of filgrastim (5 microgram/kg s.c.). Three leukaphereses collected a median of 114.9 (range, 22.7-273.5) x 10(4) granulocyte-macrophage-colony-forming cells/kg body weight. Hemopoietic recovery was rapid after each cycle, and there was no correlation between the rate of recovery and the number of granulocyte-macrophage-colony-forming cells infused. There was a small but significant progressive delay in recovery from hematological and nonhematological toxicities across the three cycles. Left ventricular ejection fraction fell to below 50% in eight (53%) patients, but none developed congestive cardiac failure. Two patients did not complete three cycles because of insufficient PBPC for a third cycle (n = 1) and 2-mercaptoethane sodium sulfonate- related drug reaction during the second cycle (n = 1). There were no deaths during the study or during the follow-up period (median, 70 weeks; range, 50-85 weeks), and no late toxicities occurred. Therefore, we concluded that the delivery of multiple cycles of nonmyeloablative, dose-intensive chemotherapy supported by PBPC and filgrastim is safe, and may be widely applicable to a variety of common chemosensitive cancers with a poor prognosis. The efficacy of three cycles of high-dose epirubicin and cyclophosphamide is to be compared with standard-dose chemotherapy in a randomized trial in patients with high-risk, operable stage II and III breast cancer.

Adolescent↗
PubMed2003

Long-term combination treatment with clozapine and filgrastim in patients with clozapine-induced agranulocytosis.

Short-term treatment with granulocyte colony-stimulating factor has been successful in reducing the duration of clozapine-induced agranulocytosis. Long-term combination treatment with filgrastim and clozapine in patients with clozapine-induced agranulocytosis has only been described in two previous cases. We describe three patients with schizophrenia who developed granulocytopenia or agranulocytosis during treatment with clozapine and who did not respond to other antipsychotics. The patients received long-term combination treatment with clozapine and filgrastim. Using a combination treatment with filgrastim and clozapine, the psychotic symptoms were successfully controlled and no haematological complications were observed during the follow-up periods of 11, 30 and 48 months, respectively. Our cases suggest that long-term treatment with filgrastim might be a useful, but exceptional, treatment approach in patients who have developed clozapine-induced granulocytopenia or agranulocytosis.

Adult↗
PubMed1999

Prospective and randomized comparison of early versus delayed prophylactic administration of granulocyte colony-stimulating factor (filgrastim) in children with cancer.

BACKGROUND: The prophylactic use of hematopoietic growth factors has been shown to reduce the duration of neutropenia and related complications encountered after anticancer chemotherapy. However, the optimal timing for initiation of granulocyte colony-stimulating factor (G-CSF) has not been established. PROCEDURE: We evaluated the clinical parameters of the early versus delayed start (+1 day vs. +5 days postchemotherapy) of filgrastim (G-CSF; 5 micrograms/kg) after 36 courses of anticancer chemotherapy in 18 children with cancer in randomized fashion. Each child received two identical anticancer chemotherapeutic courses followed by one early (group 1) and one delayed (group 2) administration of G-CSF. Filgrastim was administered until absolute neutrophil count (ANC) exceeded 1.0 x 10(9)/l. RESULTS: The mean duration of G-CSF therapy was 8.6 (range, 5-14) days in group 1 and 5.4 (range, 3-10) days in group 2 (P = 0.001). The mean duration of neutropenia (ANC < 1.0 x 10(9)/l) did not differ between the study groups (7.8 vs. 8.2 days). Seven infection episodes occurred in group 1 and eight in group 2, respectively. The mean number of hospital days on broad-spectrum antibiotics was 2.3 (range, 0-8) in group 1 and 3.3 (range, 0-11) in group 2 (ns). CONCLUSIONS: We conclude that the delayed start of filgrastim reduced the costs of this treatment, but was not followed by more prolonged neutropenia or febrile neutropenias.

Adolescent↗
PubMed2005

Dose-dense vinorelbine and docetaxel with Filgrastim support in patients with advanced nonsmall cell lung carcinoma.

BACKGROUND: Vinorelbine and docetaxel are active single agents in the treatment of nonsmall cell lung carcinoma (NSCLC) and may provide enhanced activity when combined in a dose-dense fashion. The efficacy and safety of this combination was assessed when it was administered every 14 days with Filgrastim support in a community practice setting. METHODS: This open-label study was conducted at 12 community oncology practices in the United States. Sixty-one chemotherapy-naive patients with Stage IIIB/IV NSCLC received vinorelbine 45 mg/m2 followed by docetaxel 60 mg/m2 on Day 1 and Filgrastim 5 mcg/kg beginning on Day 2, with cycles repeated every 14 days. RESULTS: Among 61 enrolled patients, 44% of patients had either a complete or partial response as their best response, and 27% of patients had confirmed complete or partial responses. The median time to confirmed response was 1.9 months (95% confidence interval [95% CI], 0.9-2.3 mos), and the median duration of confirmed response was 6.0 months (95% CI, 3.1-14.4 mos). The median time to disease progression was 4.9 months (95% CI, 3.8-5.8 mos). With a median follow-up of 14.3 months, the median survival was 12.9 months (95% CI, 8.1-14.3 mos), and the 1-year survival rate was 56% (95% CI, 43-69%). The relative dose intensity was 94% for vinorelbine and 93% for docetaxel. Febrile neutropenia occurred in 9 patients (15%) and during 9 of 351 cycles (3%). CONCLUSIONS: It was possible to administer dose-dense vinorelbine and docetaxel chemotherapy with Filgrastim support, beginning in the first cycle, to patients with NSCLC who were treated in a community practice setting.

Adult↗
PubMed2005

Harvesting peripheral blood progenitor cells from healthy donors: retrospective comparison of filgrastim and lenograstim.

Mobilization of CD34+ into peripheral blood is attained by either glycosylated (lenograstim) or non-glycosylated recombinant G-CSF (filgrastim). 101 donors, 57 males, median age 42 years (range 16-63) entered this retrospective study. Group I (55 cases) received filgrastim and group II lenograstim subcutaneously for 5-6 days. The peak number of CD34+ cells/microl blood observed on day 4 and 5 was not significantly different in the two groups. No differences were shown in terms of both circulating CFU-GM at the time of harvesting and CD34+ target of collection. The most frequent side effects were bone pain (18.2% grade I; 36.4% grade II, 7.3% grade III), headache (18.2%), nausea (9.1%), fever (5.5%) and a mild splenomegaly (> 2 cm) (5.5%) in filgrastim group, and bone pain (37.0% grade I, 26.1% grade II, 2.2% grade III), headache (17.4%), nausea (15.2%), fever (4.4%) and a mild splenomegaly (4.3%) in lenograstim group, respectively. CD34+ collection was associated with thrombocytopenia, which was not significantly different between the two groups. No donor in either group developed long-term adverse effects. We conclude that both G-CSFs are comparable in terms of CD34+ cell collection, safety and tolerability.

Adjuvants, Immunologic↗
PubMed2001

Maximal local and minimal systemic cytokine response to colorectal surgery: the influence of perioperative filgrastim.

Thirty consecutive patients scheduled for elective colorectal surgery were prospectively randomized to receive either filgrastim [the recombinant human form of granulocyte colony-stimulating factor (r-metHu-G-CSF)] or placebo blindly. The levels of interleukin (IL-)1beta, tumour necrosis factor-alpha (TNF-alpha), IL-6, IL-8, transforming growth factor-beta (TGF-beta), and IL-10 were determined 5 and 24 h postoperatively from peripheral blood, peritoneal fluid, and wound fluid. The concentrations of all the measured cytokines were enormously higher locally at the operative site than in the systemic circulation. The only difference between the two medication groups was the lower concentration of IL-8 in peripheral blood in the filgrastim-treated patients. The present study shows abundant release of pro- and anti-inflammatory cytokines into the wound and the peritoneal cavity after abdominal surgery. The systemic response to surgery seems to be a secondary and minor reflection of local events. Filgrastim did not have any effect on the studied local cytokine levels at the operative site.

Colorectal Surgery↗
PubMed1997

Randomized trial comparing the tolerability of sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in cancer patients receiving myelosuppressive chemotherapy.

A prospective, randomized, double-blind, multicenter study in cancer patients receiving myelosuppressive chemotherapy was undertaken to evaluate and compare the tolerability of sargramostim (yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor, RhuGM-CSF) and filgrastim (bacteria-derived recombinant human granulocyte colony-stimulating factor, RhuG-CSF) in the prophylaxis or treatment of chemotherapy-induced neutropenia. In all, 137 evaluable patients received sargramostim (300 micrograms; 193 mg/m2) or filgrastim (481 mg; 7 mg/kg) once daily by self-administered s.c. injection, usually beginning within 48 h after completion of chemotherapy. With the exception of a slightly higher incidence of grade 1 fever (< 38.1 degrees C) with sargramostim, there were no statistically significant differences in the incidence or severity of local or systemic adverse events possibly related to the growth factors. Although the study was not designed to evaluate efficacy directly, there also were no statistically significant differences between treatment groups in total days of growth factor therapy, days of hospitalization, or days of i.v. antibiotic therapy during the treatment period. Both sargramostim and filgrastim were comparably well tolerated when given by s.c. injection in this group of patients, and no clinically significant differences between the growth factors were demonstrated.

Chi-Square Distribution↗
PubMed2003

Biweekly docetaxel-irinotecan with filgrastim support in pretreated breast and non-small-cell lung cancer patients. A phase I study.

BACKGROUND: Docetaxel (DTX) has been shown to be a very active drug in both breast cancer (BC) and non-small-cell lung cancer (NSCLC). Irinotecan (CPT-11) is also active in NSCLC, and has shown promising antitumor activity in pretreated BC. PURPOSE. To define the MTDs of these two drugs given together every other week with the use of filgrastim support in pretreated BC and NSCLC patients. PATIENTS AND METHODS: Patients (aged 18-70 years, performance status < or =2) with advanced NSCLC or BC who had received at least one prior chemotherapy regimen were candidates for this phase I study. The starting DTX and CPT-11 doses were 60 mg/m(2) and 80 mg/m(2). Doses were alternately escalated at each step by 10 mg/m(2) for both drugs. Filgrastim 300 microg/day was given subcutaneously from days 4 through 7 of each cycle. RESULTS: From April 2000, 41 patients were included in the trial (27 BC, 14 NSCLC). All BC patients had received epirubicin plus paclitaxel (with or without cisplatin) as first-line treatment. Of the 14 NSCLC patients, 12 had received cisplatin-based first-line therapy, and 8 patients had been pretreated with paclitaxel. The dose escalation proceeded through five dose levels up to DTX and CPT-11 doses of 80 mg/m(2) and 100 mg/m(2), respectively. Overall, ten patients showed dose-limiting toxicity during the first cycle, diarrhea in seven and neutropenia in the remaining three. Considering all 218 cycles delivered, grade 3 or 4 neutropenia occurred in 14 patients (34%), with only one episode of neutropenic fever, while severe diarrhea was observed in 9 patients (23%). A total of 21 objective responses were registered (four complete) for an overall response rate of 51% [95% CI 35-67]. A major response was seen in 16 of the 27 BC patients (59%) and in 5 of the 14 NSCLC patients (36%). CONCLUSIONS: DTX and CPT-11 can be safely given together biweekly at adequate doses, with filgrastim support. In view of the promising activity data in both groups, phase II studies testing this combination in pretreated BC and NSCLC patients are ongoing.

Adult↗
PubMed1999

Inability to escalate vinorelbine dose intensity using a daily x3 schedule with and without filgrastim in patients with metastatic breast cancer.

PURPOSE: Vinorelbine (Navelbine) is a semi-synthetic vinca alkaloid with documented activity in breast cancer. The major dose-limiting toxicity (DLT) when given weekly is myelosuppression with minimal neurologic toxicity. This phase I study attempted to define the maximally tolerated dose (MTD) and the DLT of vinorelbine on a daily x3 schedule with and without filgrastim support. METHODS: A total of 19 patients with stage IV breast cancer were enrolled in separate studies at Duke University Medical Center (DUMC) and the Dana-Farber Cancer Institute (DFCI). Eligible patients could have received up to two prior chemotherapy regimens in the metastatic setting and had to have an ANC > 1500/mm2, PLT > 100000 m3, creatinine < 2.0 mg/dl, bilirubin < 2.0 mg/dL, SGOT not more than three times normal, and performance status 0-1. Vinorelbine was administered using a daily x3 schedule every 3 weeks. The protocols were designed to study dose escalation with and without growth factor support. At DUMC, in the initial phase of the study, the starting dose was 15 mg/m2 per day and dose escalations of 5 mg/m2 were planned until DLT developed and the MTD was defined. DLT was defined as granulocytopenia < 500/mm3 for > 7 days, grade IV thrombocytopenia, febrile neutropenia, or grade III or greater nonhematologic toxicity. In the second phase of the study, growth factor support was given with vinorelbine at the MTD. Filgrastim at a dose of 5 microg/kg was started on day 4 of the 21-day cycle and was continued until the neutrophil count exceeded 10000 cells/ mm3. At DFCI, all patients received growth factor starting on day 4 and the starting dose of vinorelbine was 25 mg/m2. RESULTS: At DUMC, DLT was seen at 20 mg/m2 in three of three patients and included febrile neutropenia, grade IV neutropenia > 7 days, grade III neurotoxicity, and grade III vomiting. Despite the addition of filgrastim, DLT was again seen at 20 mg/m2 and included grade III neurotoxicity (jaw pain, abdominal pain, constipation, ileus) and grade IV mucositis. Three patients at DFCI were treated with vinorelbine at a dose of 25 mg/m2 with growth factor support, and two developed DLT including febrile neutropenia, neutropenia > 7 days, and grade III stomatitis. CONCLUSIONS: Our effort to escalate the dose intensity of vinorelbine on this schedule was not successful and was complicated by hematologic and nonhematologic toxicity. A daily x3 schedule of vinorelbine should not be pursued as an alternative treatment regimen in patients with previously treated metastatic breast cancer.

Adult↗
PubMed2006

Pegfilgrastim compared with Filgrastim after autologous hematopoietic peripheral blood stem cell transplantation.

In order to assess the effect of Pegfilgrastim on the duration of neutropenia and clinical outcome of patients after autologous peripheral blood stem cell (PBSC) transplantation, we compared 20 consecutive patients with lymphoma or multiple myeloma receiving a single 6-mg dose of Pegfilgrastim on day 1 posttransplant to an historical control group of 60 patients receiving daily Filgrastim 5 microg/kg starting on day 1 posttransplant. The duration of neutropenia was similar in the Pegfilgrastim group compared with the control group. There were no differences in time to neutrophil, erythroid, or platelet engraftment nor in the incidence of fever and infections. The duration of antibiotic therapy, transfusion support, and time to hospital discharge were similar in the two groups. However, after initial hematopoietic reconstitution, we observed significantly higher values of lymphocytes (e.g., 1,660+/-1,000 versus 970+/-460 on day 80, p=0.0002), neutrophils (e.g., 3,880+/-2,030 versus 2,420+/-1,500 on day 25, p=0.0004), reticulocytes (e.g., 148,160+/-90,590 versus 87,140+/-65,920 on day 25, p<0.0001), and platelets (e.g., 210,700+/-116,090 versus 150,240+/-58,230 on day 55, p=0.0052) up to day 100 in the Pegfilgrastim group compared with the Filgrastim group. These observations had no impact on clinical outcome of the patients after day 30 due to the low incidence of infectious events after engraftment in autologous PBSC transplantation. We conclude that the effect of Pegfilgrastim administrated on day 1 posttransplant is comparable to that of daily Filgrastim on initial hematopoietic reconstitution. The possibly superior effect of Pegfilgrastim on cell counts we observed after initial engraftment should be further tested in a prospective randomized trial.

Antineoplastic Agents↗
PubMed1998

A brief intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for advanced non-small cell lung cancer: results of a phase II trial.

To evaluate the efficacy and toxicity of a brief, intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for patients with stage IIIB and IV non-small cell lung cancer (NSCLC) and a favorable performance status. Thirty patients with no prior chemotherapy were enrolled in this phase II protocol. Patients received cisplatin 50 mg/m2, ifosfamide 2 g/m2, mesna, and a 7-day course of oral etoposide beginning on days 1, 15, 29, 43. and 57 for a total treatment duration of 10 weeks. Filgrastim was administered for 7 days after each course of oral etoposide. Megestrol acetate 250 mg PO was administered throughout the duration of chemotherapy. Thirty patients were evaluable for toxicity and 27 for response. Among those evaluable for response, partial remission occurred in 11 (41%) patients, and median survival was 10.5 months. Nadir neutrophil count of < 500/mm3 occurred in 19 (63%) patients. Weight loss occurred in only nine patients (median 3.4 kg, range 1.6-7.3). There was no difference between pre- and post-treatment weights (P=0.35). Two patients developed pulmonary embolism. Grade 3 or 4 non-hematologic toxicity occurred infrequently. This regimen appears to be similar in efficacy to the most active regimens reported by other investigators. Innovative features of the regimen include the brief treatment duration, the use of serial 7-day courses of filgrastim to facilitate weekly chemotherapy treatments, and the use of megestrol acetate to minimize constitutional symptoms. However the use of megestrol acetate in this setting may be associated with an increased risk of thromboembolic complications. This may provide a model for other palliative regimens specifically designed for patients with a favorable performance status and advanced NSCLC.

Adenocarcinoma↗
PubMed1995

Increasing and planned dose intensity of doxorubicin, cyclophosphamide and etoposide (ACE) by adding recombinant human methionyl granulocyte colony-stimulating factor (G-CSF; filgrastim) in the treatment of small cell lung cancer (SCLC). Medical Research Council Lung Cancer Working Party.

The aim of this Phase II study was to test the feasibility of intensifying standard chemotherapy in the treatment of small cell lung cancer (SCLC) by reducing the interval between cycles from 3 to 2 weeks by adding recombinant human methionyl granulocyte colony-stimulating factor (G-CSF; filgrastim) to shorten the duration of neutropenia following each cycle. Thirty-two patients with SCLC were prescribed six cycles of 2-weekly doxorubicin 50 mg/m2 and cyclophosphamide 1 g/m2 on day 1, and etoposide 120 mg/m2 i.v. on days 1, 2 and 3 (ACE), plus filgrastim in a fixed dose of 300 micrograms s.c. on days 4-14 of each cycle. Three patients died during the treatment period and a further nine had chemotherapy terminated before the sixth cycle, all nine because of toxicity. All 32 patients have been followed up for at least 21 months; 14 (44%) were alive at 12 months and the median survival period was 356 days. Of the 127 intervals between cycles of chemotherapy, 74 (58%) were of the prescribed 14 days, 18 (14%) of 15-20 days, 25 (20%) of 21 days, and 10 (8%) were longer. The results were best during the first four cycles, during which 71% of the 83 intervals were of 14 days and a further 10% were less than 21 days. The main reason for delay was haematological toxicity in 37 of the 53 instances. Symptoms of myelosuppression occurred in 23 patients, but at 14 days after a cycle of chemotherapy, all 127 available neutrophil granulocyte counts were normal. Twenty-one patients received blood transfusion and five platelet transfusion. The only adverse effects attributed to filgastrim were episodes of rash, throat swelling, anorexia and shivering, affecting one patient. We conclude that the policy of adding filgrastim allows the dose intensity of ACE chemotherapy to be increased by reducing the intervals between cycles. The findings reinforce those of a parallel study involving lenograstim.

Aged↗