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PubMed1996

Phase II study of recombinant human granulocyte colony-stimulating factor in children undergoing bone marrow transplantation.

Twenty-three children with congenital or acquired hematological disorders and 8 children with solid tumors received filgrastim at a dose of 5 micrograms/Kg by a daily 2-hour infusion following allogeneic (18 cases) or autologous (13 cases) bone marrow transplantation (group I). The results were compared with those of a disease, age and type of transplant matched cohort of 31 children treated in the same institution who did not receive the growth factor (group II). Filgrastim treatment was started within 24 hours of completion of the marrow infusion and lasted for 21 consecutive days or until the absolute neutrophil count reached 10 x 10(9)/l for 3 consecutive days. Twelve variables were evaluated prospectively in Group I and retrospectively in Group II. Myeloid reconstitution with peripheral granulocyte counts > 0.5 x 10(9)/L was achieved at a median time of 13 days in group I and of 14 days in group II (p = ns). Platelet recovery to > 50 x 10(9)/L was slower in group I (43 vs 30 days: p < .05). Median time to last platelet and red blood cell infusion was higher in group I (33 vs 18 days for platelets, p < .05; 45 vs 25 for red blood cells, p < .005). Filgrastim-treated children undergoing autologous BMT had fewer days of fever (6 vs 10 days, p < .05). There was no significant toxicity ascribable to filgrastim. Clinically and microbiologically documented infections, days of antibiotic therapy, duration of total parenteral nutrition and median time in hospital were similar in both groups. We conclude that in children undergoing autologous BMT for malignancies, filgrastim significantly reduced the number of febrile days. Similar benefits were not observed in children undergoing allogeneic BMT. Children receiving filgrastim experienced a delay in erythrocyte and platelet recovery. A prospective randomized study is required to better define the cost-benefit of filgrastim in children undergoing autologous or allogeneic BMT.

Adolescent↗
PubMed1999

Treatment of HIV-related neutropenia.

Several studies documenting the association of bacteremia and severity of neutropenia in HIV-infected patients, as well as studies using the colony stimulating factors filgrastim or sargramostim to prevent and treat neutropenia in this patient population, are summarized. Three studies are described in which low absolute neutrophil count was associated with increased incidence of bacterial infections in patients with HIV infection. Two hematopoietic growth factors called colony stimulating factors (filgrastim and sargramostim) are available in the United States, but neither is approved by FDA for the treatment or prevention of neutropenia in HIV-infected patients. Studies have shown both filgrastim and sargramostim to be effective in treating neutropenia in HIV-infected patients without increasing the viral load. In one study, filgrastim use on a daily or intermittent basis was associated with reduction in severe neutropenia or death; in addition, filgrastim-treated patients had fewer bacterial infections, fewer hospital days (both total number of days and days associated only with bacterial infections), and a reduced need for i.v. antimicrobials compared with HIV-infected controls. In another study, neutropenia caused by zidovudine was successfully treated with sargramostim. Both filgrastim and sargramostim show promise in treating and preventing neutropenia in HIV-infected patients. More research is needed to determine the patient population who can best benefit from therapy with these agents and to determine the relative advantages and disadvantages of filgrastim and sargramostim.

HIV Infections↗
PubMed2000

A novel approach to maintain planned dose chemotherapy on time: a decision-making tool to improve patient care.

Studies of primary prophylaxis of febrile neutropenia with recombinant granulocyte colony-stimulating factor (r-metHuG-CSF, filgrastim), administered to all patients starting with the initial course of chemotherapy, have demonstrated an economic advantage over a wide range of settings. In these analyses, the threshold risk for febrile neutropenia at which a cost saving is realised is inversely related to the direct medical costs of hospitalisation. Clinical practice guidelines for the use of filgrastim have been developed based on these observations. Recent studies incorporating indirect institutional costs have demonstrated that cost savings can be achieved at substantially lower febrile neutropenia risk thresholds than previously estimated. Despite the demonstrated efficacy of filgrastim in primary prophylaxis, its value may be further enhanced through the appropriate selection of patients for such therapy and a better understanding of the importance of sustaining dose intensity in specific malignancies. Clinical prediction models capable of identifying individuals at high risk for neutropenic complications yield further reductions in febrile neutropenia risk thresholds and treatment costs in patients receiving cancer chemotherapy. Prediction models can also be used to evaluate the cost-effectiveness or cost-efficiency of filgrastim use. Such a model has recently been developed and validated and is described here which incorporates both baseline clinical characteristics as well as the results of the first cycle of chemotherapy in patients with early-stage breast cancer. A cost-effectiveness ratio of US$ 34297 (Euro 32002)dagger per year of life saved (YLS) was calculated based on dose-response assumptions derived from a previously reported adjuvant breast cancer trial studying the impact of dose reduction on disease-free survival. This figure is comparable with accepted cost-effectiveness ratios for other interventions, e.g. US$ 45000/LYS (Euro 41989) for renal dialysis for patients with end-stage renal disease. The cost-effectiveness of filgrastim was evident over a wide range of clinical and cost assumptions. Clinical prediction models permit rational and cost-effective selection of patients for filgrastim support. Current guidelines should be re-evaluated in light of new information available on both the total cost of febrile neutropenia, as well as the cost-effectiveness of these agents in specific clinical situations.

Antineoplastic Agents↗
PubMed1999

Cyclophosphamide and paclitaxel as initial or salvage regimen for the mobilization of peripheral blood progenitor cells.

Peripheral blood progenitor cells are now commonly used for hematologic reconstitution after myelosuppressive chemotherapy for hematologic and solid malignancies. The purpose of this study was to evaluate the activity of paclitaxel 170 mg/m2 and cyclophosphamide 2 g/m2 (CP) with filgrastim (human G-CSF) for mobilization of PBPCs as the first or second maneuver after failure with filgrastim alone. Sixty-four patients with stage II-IV breast cancer received (CP) followed by filgrastim (10 microg/kg/day). In 35 (55%) this was the first maneuver while it was for salvage in 29 (45%) patients. The median number of aphereses was two (range, 1-7). In 83% of the patients apheresis was initiated on days 10-11 following chemotherapy. The median numbers of CD34+ cells/kg, CD34+ cells/apheresis/kg and total nucleated cells/kg collected were 8.7 x 10(6) (2.11-73.5), 3.97 x 10(6) (0.3-36.75) and 164.15 x 10(8) (9-660), respectively. All the patients yielded at least 2 x 10(6) CD34+ cells/kg. CP mobilization salvaged the 29 patients who failed mobilization with filgrastim alone. When used as first-line mobilization the yield of CD34+ cells x 10(6)/kg was higher than in the salvage group (16.93 vs 3.94, P < 0.001). Patients receiving CP as salvage reached the target of 5 x 10(6) CD34+ cells/kg in only 45% (13/29) of cases vs 94.3% as first maneuver. CP followed by filgrastim is a safe and effective regimen for the mobilization of PBPCs in patients with breast cancer and shows significant activity in patients who failed to mobilize with filgrastim, suggesting a higher mobilization potential.

Adult↗
PubMed2005

Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study.

Pegfilgrastim is equivalent to daily filgrastim after standard dose chemotherapy in decreasing the duration of neutropenia. Daily filgrastim started within 1-4 days after autologous stem cell transplant (ASCT) leads to significant decrease in time to neutrophil engraftment. We undertook a study of pegfilgrastim after high-dose chemotherapy (HDC) and ASCT. In all, 38 patients with multiple myeloma or lymphoma, eligible to undergo HDC and ASCT, were enrolled. Patients received a single dose of 6 mg pegfilgrastim subcutaneously 24 h after ASCT. There were no adverse events secondary to pegfilgrastim. All patients engrafted neutrophils and platelets with a median of 10 and 18 days, respectively. The incidence of febrile neutropenia was 49% (18/37). Neutrophil engraftment results were compared to a historical cohort of patients who received no growth factors or prophylactic filgrastim after ASCT. Time to neutrophil engraftment using pegfilgrastim was comparable to daily filgrastim and was shorter than in a historical group receiving no filgrastim (10 vs 13.7 days, P<0.001). Pegfilgrastim given as a single fixed dose of 6 mg appears to be safe after HDC and ASCT. It accelerates neutrophil engraftment comparable to daily filgrastim after ASCT. Pegfilgrastim may be convenient to use in outpatient transplant units.

Adult↗
PubMed2005

Same-day pegfilgrastim and chemotherapy.

Pegylated filgrastim is a new formulation of a neutrophil colony-stimulating factor that has a long circulating half-life, permitting a single dose of filgrastim per cycle of chemotherapy. The pegylated filgrastim is recommended to be administered not less than 24 hours following chemotherapy and not less than 14 days prior to chemotherapy based on the theoretic concern that marrow suppression would be accentuated. This schedule of usage for pegylated filgrastim may compromise its application for weekly chemotherapy schedules. We have treated 80 patients with pegylated filgrastim administered on the same day as chemotherapy; the latter delivered on a weekly schedule. Twenty-four patients had non-small cell lung cancer (NSCLC) and were treated with one of two weekly chemotherapy regimens alternating triplets [AT] taxane, cisplatin, irinotecan alternating with gemcitabine, cisplatin, vinorelbine or alternating doublets [AD] taxane, cisplatin alternating with gemcitabine, vinorelbine; four of these patients also received weekly taxane and carboplatin with concomitant thoracic radiation. A consistent pattern emerged in which leukocytosis was observed at Day 8; median WBC 15,800/uL (range 7,200 to 35,000/uL); at Day 14, the median WBC was 9,300/uL (range 1,100 to 17,400/uL). Pegylated filgrastim can be given safely simultaneously with chemotherapy in weekly chemotherapy schedules. The pegfilgrastim can be administered on an every two week (fortnightly) schedule to maintain a weekly chemotherapy schedule.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Health care outcomes case study: Febrile neutropenia.

A case study of the clinical and economic impact of filgrastim in cancer patients in the home care setting is described. The risk of febrile neutropenia is greatly reduced when filgrastim therapy is begun prophylactically after a course of antineoplastic drug therapy. Such use of filgrastim may also reduce the need for hospitalization, prevent mucositis, and enable the next course of chemotherapy to be administered on schedule. Investigators at the University of New Mexico, noting studies showing merit in early hospital discharge of pediatric cancer patients with febrile neutropenia, decided to take the approach a step further by treatment febrile neutropenia entirely at home. Patients seen in the pediatric oncology clinic at the university hospital were considered candidates for home treatment if they had stable vital signs, were already receiving filgrastim after the completion of cancer chemotherapy, and lived within one hour of the hospital. Six cancer patients 2-17 years of age were studied between August 1992 and February 1994. These patients had 16 episodes of febrile neutropenia that were treated at home. The drug regimen consisted of prophylactic filgrastim (begun the day after completion of a course of antineoplastic therapy) and ceftazidime (when febrile neutropenia developed). None of the children were readmitted to the hospital. Infections resolved within 12 days in all cases. The total charge for treating the 16 episodes at home was $22,400 (drug charge for ceftazidime, visits by nurses, infusion-pump rental, and ancillary charges). The total charge for hospital treatment of these episodes would be $112,924 (bed charge and pharmacy charge). The difference suggests a potential savings of $90,524 from home care for this small group of patients. Treating febrile neutropenia in pediatric cancer patients at home is effective and cost-efficient if the patients are clinically stable and prophylactic filgrastim therapy has been started after the completion of cancer chemotherapy.

Adolescent↗
PubMed2003

Pegfilgrastim: using pegylation technology to improve neutropenia support in cancer patients.

Pegylation of a protein can improve not only its formulation properties, but also both its pharmacokinetic and pharmacodynamic performance. Pegfilgrastim was made by linking a 20-kDa polyethylene glycol molecule to filgrastim, producing a long-acting cytokine requiring less frequent dosing than its parent drug. This review describes the clinical development of pegfilgrastim, and discusses its potential benefits to patients and caregivers in the prophylaxis of chemotherapy-induced neutropenia. Pegfilgrastim has a longer half-life and slower elimination rate than filgrastim, resulting in an increased serum concentration over time. Serum levels of pegfilgrastim are maintained until after a chemotherapy-induced neutrophil nadir and then decline rapidly as the neutrophil count recovers, consistent with a neutrophil-mediated clearance mechanism. In two pivotal phase III studies of women receiving chemotherapy for breast cancer, a single injection of pegfilgrastim per chemotherapy cycle, dosed either by body weight (100 microg/kg) or as a fixed dose (6 mg), was comparable to daily filgrastim (5 microg/kg) for all efficacy parameters, including duration of severe neutropenia and depth of neutrophil nadir. Analysis of pooled data from these studies showed a significantly lower incidence of febrile neutropenia in patients receiving pegfilgrastim compared with filgrastim (11 versus 19%, p<0.05), and a trend towards a lower risk of hospitalization and use of i.v. anti-infectives. The safety profiles of pegfilgrastim and filgrastim were similar. Pegfilgrastim given once per chemotherapy cycle is as effective and well tolerated as daily injections of filgrastim. With its more convenient dosing regimen, pegfilgrastim has the potential to improve quality of life and compliance in patients, and to be more cost effective.

Antineoplastic Agents↗
PubMedDate not supplied

The use of granulocyte colony-stimulating factors following peripheral blood progenitor cell rescue after high-dose chemotherapy for advanced breast cancer: a prospective study.

The use of high-dose chemotherapy followed by hematopoietic rescue is increasing worldwide for solid tumors. Several studies have suggested that the period of absolute neutrophil count (ANC, < 500/ml) may be shortened in patients who receive peripheral blood progenitor cells (PBPC). To estimate the clinical value of granulocyte-colony-stimulating factor, we examined a cohort of 26 consecutive patients with advanced breast cancer who received one or two cycles of high-dose chemotherapy with PBPC rescue with or without filgrastim. Thirty-five courses of high-dose ICE (ifosfamide, carboplatin, etoposide) chemotherapy were administered and evaluated. All patients received PBPC rescue. Sixteen patients (21 courses) received subcutaneous filgrastim (5 mg/kg) following PBPC infusion. Recovery to > or = 500 ANC occurred at a median time of 7 days post PBPC infusion among patients who received filgrastim versus 10 days among patients who received standard support care only (P < 0.01). The administration of filgrastim was not associated with a reduction in the duration of hospitalization, in the total number of days on nonprophylactic antibiotics, number of red blood cell transfusions, time to platelet engraftment, or number of febrile days. This could be the consequence of the high hematopoietic cell dose administered in the study. Therefore, any effect of filgrastim was probably masked by the use of a large number of PBPC. Larger prospective randomized studies, specifically focused on the utility of the administration of growth factors following high-dose chemotherapy and PBPC rescue, may be warranted to know whether the administration of filgrastim after PBPC transplantation is really necessary.

Adult↗
PubMed1995

Phase I study of paclitaxel and topotecan in patients with advanced tumors: a cancer and leukemia group B study.

PURPOSE: To define the dose-limiting toxicities (DLTs) and the recommended phase II doses of paclitaxel combined with topotecan, without and with filgrastim support. PATIENTS AND METHODS: Patients with advanced solid tumors and a maximum of one prior chemotherapy regimen for metastatic disease were eligible if they had a performance status of 0 to 1 and normal renal, hepatic, and bone marrow function. Prior treatment with taxanes or comptothecin analogs, and prior pelvic irradiation were not allowed. Patients with a history of cardiac disease or on medications known to affect cardiac conduction were excluded. The dose of topotecan was fixed at 1.0 mg/m2/d for 5 days. The dose of paclitaxel was escalated until the maximum-tolerated dose (MTD), without and with filgrastim 5 micrograms/kg subcutaneously (SC) on days 6 to 14, was reached. Paclitaxel was administered over 3 hours on day 1 before topotecan. Treatment cycles were repeated every 21 days. RESULTS: Of 46 patients entered, 45 were assessable for toxicity and 34 for response. The principal toxicity was neutropenia. Without filgrastim, the MTD of paclitaxel was 80 mg/m2 on day 1 in combination with topotecan 1.0 mg/m2/d for 5 days. With filgrastim, the dose of paclitaxel was escalated to 230 mg/m2 in combination with the same dose of topotecan. At this dose level, one patient had hematologic DLT and a second patient developed neuromuscular DLT. Three patients had a partial response (PR): one with head and neck cancer, a second with non-small-cell lung cancer, and the third with colon cancer. CONCLUSION: We conclude that paclitaxel can be given at clinically relevant doses in combination with topotecan and filgrastim. The recommended dose for phase II studies is paclitaxel 230 mg/m2 on day 1 and topotecan 1.0 mg/m2/day for 5 days with filgrastim 5 micrograms/kg on days 6 to 14.

Adult↗
PubMed2005

Increasing chemotherapy dose density and intensity: phase I trials in non-small cell lung cancer and non-Hodgkin's lymphoma.

Dose densification and dose escalation of cytotoxic chemotherapy may be important in improving the cure rates of chemotherapy-responsive cancers. We conducted two phase I studies, in non-small cell lung cancer (NSCLC) and in lymphoma, to explore the possibility of intensifying chemotherapy by compressing the delivery of and escalating the dose of standard combination chemotherapy. One study used etoposide and cisplatin chemotherapy in patients with unresectable stage III or IV NSCLC, intensifying chemotherapy by reducing the cycle length. The second study used cyclophosphamide, doxorubicin, vincristine, and prednisone, CHOP chemotherapy, in the treatment of stage II-IV intermediate or immunoblastic high-grade lymphoma, intensifying chemotherapy first by reducing the cycle length and then by escalating the dosages of cyclophosphamide and doxorubicin. Filgrastim support was used during dose intensification. Fifty-five patients with NSCLC and 49 with non-Hodgkin's lymphoma (NHL) were enrolled and treated in successive cohorts. At standard dosages and intervals of chemotherapy, filgrastim support resulted in incidences of grade 3 and 4 neutropenia that were between 62% and 77% lower than those in the no-filgrastim control; the mean duration of neutropenia was, likewise, more than 80% lower. Absolute neutrophil counts were >/=2 x 10(9)/l at day 14 in virtually 100% of patients receiving filgrastim. In the NSCLC trial, etoposide and cisplatin were intensified by >50%, and in the lymphoma trial, cyclophosphamide was intensified by 270% and doxorubicin was intensified by 87%. Chemotherapy reductions or delays for neutropenia were rare in the groups receiving filgrastim; but at higher chemotherapy intensities, dose-limiting thrombocytopenia was encountered. We conclude that the delivery of myelosuppressive chemotherapy in both a dose-intense and a dose-dense manner is feasible with filgrastim support.

Adult↗
PubMed2002

Pegfilgrastim administered once per cycle reduces incidence of chemotherapy-induced neutropenia.

Neutropenia is a common and potentially dangerous adverse effect of cancer chemotherapy. It also often necessitates a reduction or delay in dose, thus compromising efficacy. The human granulocyte colony-stimulating factor filgrastim has been proven to have a good safety profile and to be effective in accelerating neutrophil recovery and reducing the incidence of infections following myelosuppressive chemotherapy. However, its short serum half-life necessitates daily administration. Pegylated filgrastim (pegfilgrastim) was developed by attaching a polyethylene glycol moiety to the filgrastim protein. Pegfilgrastim binds to the same cell surface receptor on neutrophils and their precursors as filgrastim and stimulates the proliferation and differentiation of neutrophils through the same mechanism. However, because of the pegylation, it is minimally cleared by the kidneys and has a much longer serum half-life. Furthermore, its clearance is neutrophil dependent and thus 'self-regulated'. Pegfilgrastim is administered as a single subcutaneous injection per cycle of chemotherapy. In clinical trials it has been shown to be comparable in efficacy to filgrastim in decreasing the incidence of infection as manifested by febrile neutropenia following chemotherapy. Its safety profile and tolerability are similar to those of filgrastim.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2002

Neutrophil growth factors.

A significant advance in the field of neutrophil growth factors has occurred with the commercial availability of pegfilgrastim (Neulasta, Amgen, Thousand Oaks, CA), a new-generation, pegylated filgrastim molecule with a sustained duration of action. Pegylation of filgrastim allows once-per-chemotherapy cycle frequency of administration, in contrast to repeated daily administration of filgrastim. Clinical data from two randomized trials demonstrate equivalence of pegfilgrastim and filgrastim in duration of severe neutropenia and recovery from absolute neutrophil count nadir following myelosuppressive chemotherapy. In addition, secondary endpoint results in both trials suggest an enhanced reduction in the overall incidence of febrile neutropenia with pegfilgrastim. Neutrophil kinetic studies demonstrate steady serum neutrophil levels following pegfilgrastim administration, in contrast to the peak-and-trough neutrophil effects observed following filgrastim administration. Granulocyte colony-stimulating factor (G-CSF) therapy has an antiapoptotic effect on neutrophils, which may be enhanced by continuous serum concentrations of pegfilgrastim. Monocytes possess a G-CSF receptor, and this finding has fueled investigational analysis of the role of G-CSF as a mediator in the host inflammatory response to foreign pathogens. The data demonstrate that depending on the timing of administration, G-CSF may function as a proinflammatory mediator or an anti-inflammatory mediator. It is likely that the early, prophylactic administration of pegfilgrastim creates an environment in which an anti-inflammatory response predominates. Additional investigational studies will be necessary to confirm and better define the mechanism for enhanced benefit of pegfilgrastim over filgrastim. The recent biologic findings of the mechanism of G-CSF therapy reviewed here provide a strong basis from which further research initiatives may be conducted.

Filgrastim↗
PubMed2002

Colony-stimulating factors: beyond the effects on hematopoiesis.

The effects of sargramostim and filgrastim on hematopoietic cells are described. Filgrastim is a lineage-specific colony-stimulating factor (CSF), mainly affecting neutrophils. In addition to enhancing neutrophil recovery, filgrastim may also enhance neutrophil functional activity. Filgrastim does not have any meaningful effect on monocytes or macrophages; however, recent data indicate that filgrastim has a stimulatory effect on Th2 lymphocyte-inducing dendritic cells. These dendritic cells facilitate humoral immune responses, but they also produce inhibitory cytokines that diminish cell-mediated immunity. Sargramostim is a multilineage CSF, affecting neutrophils, monocytes, macrophages, and dendritic cells. Sargramostim has a greater impact on Th1 lymphocyte-inducing dendritic cells, which facilitate cell-mediated immune responses, including antitumor activity. The broader activity of sargramostim on both types of antigen-presenting cells (macrophages and dendritic cells) may account for the reports of benefit beyond enhanced neutrophil recovery that have been seen in clinical trials of patients with leukemia and patients undergoing stem-cell transplantation. Given the disparate activity of these two CSFs on the immune system and the types of immune responses generated, it is prudent for clinicians to consider these effects when choosing an agent for enhancing neutrophil recovery in various clinical settings.

Filgrastim↗
PubMed2002

Formulary management of colony-stimulating factors.

The outcome of a formulary interchange from filgrastim to sargramostim for the amelioration of neutropenia for outpatients receiving myelosuppressive chemotherapy was evaluated. The pharmacy department at the James Graham Brown Cancer Center of the University of Louisville Hospital implemented a therapeutic interchange program by following the Joint Commission on Accreditation of Healthcare Organizations performance methodology, incorporating four key elements: plan, do, check, and act. After the pharmacy and therapeutics committee agreed that filgrastim and sargramostim are therapeutically equivalent, the pharmacy initiated the interchange, with a commitment to collect outcomes data to analyze the impact of the program on patient outcomes. Inclusion criteria included patient age of > or = 18 years, the presence of solid tumors or lymphoma, and current treatment with traditional chemotherapy. Patient demographics and cycle-specific data were collected for 31 patients receiving sargramostim and 20 patients receiving filgrastim from August 2000 to July 2001. Absolute neutrophil counts (ANCs) were measured before initiating and after discontinuing colony-stimulating factors. The majority (70%) of all growth factor use was initiated within one to four days of the last chemotherapy dose. No appreciable difference was found between agents for median ANC at any measured time point. The majority of patients exceeded the target ANC of 1500 cells/mm3 at the time of growth factor discontinuation. There were no significant differences in the number of patients that had adverse effects or in the number of cycles resulting in an adverse event between groups. Sargramostim demonstrated a 21% cost savings over filgrastim ($1036 versus $1318, respectively). The formulary switch from filgrastim to sargramostim resulted in a significant cost savings for the institution without increasing incidence of adverse effects and negative outcomes associated with growth factor use.

Chemistry, Pharmaceutical↗
PubMed1998

Assessing the value of a new pharmaceutical. A feasibility study of contingent valuation in managed care.

OBJECTIVES: The authors assessed the feasibility and construct validity of the contingent valuation method for measuring the monetary value to healthy enrollees in a health maintenance organization of a new drug, filgrastim, as prophylaxis against febrile neutropenia after chemotherapy treatment for cancer. METHODS: A random sample of 220 enrollees from a closed-panel staff-model health maintenance organization who did not have cancer were interviewed. Chemotherapy, febrile neutropenia and filgrastim were described by video and decision board. Questions were asked in two different scenarios: (1) User-based: Assuming they were at the point of consumption and about to receive chemotherapy, what is the maximum they would be willing to pay to receive filgrastim? and (2) Insurance-based: Given they were at risk of cancer in the future, what is the maximum they would be willing to pay in additional monthly insurance premiums to add filgrastim to the plan? In a second insurance scenario where respondents were told that filgrastim was covered, what is the minimum reduction in premium that persons were willing to accept to relinquish coverage of the drug? A 2 x 2 factorial design was used to contrast two bidding algorithms to test for starting point bias and two 5-yearly prior risks of cancer, 1/200 versus 1/100. Main effects were tested by ANCOVA controlling for age, sex, health, and income. RESULTS: Demographics of experimental cells were similar. No evidence was found of significant starting point bias. For user-based questions, as expected, willingness-to-pay increases with febrile neutropenia risk reduction, but at a declining marginal rate. Despite careful presentation of information to respondents, willingness-to-pay for insurance was higher in the lower prior risk group. Consistent with previous contingent valuation studies, the authors of the present study found evidence that willingness-to-accept exceeds willingness-to-pay for coverage of the same benefit. CONCLUSIONS: An insurance-based contingent valuation study is feasible in a health maintenance organization. Construct validation evidence was encouraging, with the exception of the test for prior risk of cancer; however, this was a between-person contrast and may have been confounded by other factors.

Adult↗
PubMed2004

Efficacy and safety of two different rG-CSF preparations in the treatment of patients with severe congenital neutropenia.

In patients with severe congenital neutropenia (SCN), the absolute neutrophil count (ANC) is raised during treatment with granulocyte colony-stimulating factor (G-CSF), resulting in a marked reduction of bacterial infection. Some patients, however, still have recurrent but less severe bacterial infections and severe periodontal infections. As it has been suggested that the biological activity of glycosylated recombinant human G-CSF (rHuG-CSF, i.e. lenograstim) is higher than the non-glycosylated form (i.e. filgrastim), we compared the two given in equimolar doses. Seven SCN patients participated in an open, randomized, double crossover study comprising 60 weeks, with four 12-week periods when the two drugs alternated after a 12-week run-in-period. The mean ANC values, sampled every second week, were 5.1 x 10(9)/l during filgrastim treatment and 4.2 x 10(9)/l during lenograstim treatment (P = 0.042). The ANC levels were also significantly higher during filgrastim treatment, when comparing each complementary pair of ANC measurements (P = 0.011) as well as the mean ANC values during each 12-week treatment period (P = 0.033). There were no differences regarding the frequency of infection, antibiotic treatment, gingival bleeding and the number of hospital admissions between the groups. We conclude that filgrastim and lenograstim displayed equal clinical efficacy, but that ANC levels were higher during filgrastim treatment, when administered in equimolar doses.

Child, Preschool↗
PubMedDate not supplied

Pegfilgrastim for chemotherapy-induced neutropenia.

Many chemotherapy regimens cause myelosuppression, which can result in febrile neutropenia and potentially lead to serious infections. The risk of neutropenia and its complications can be reduced with filgrastim, a granulocyte-colony-stimulating factor. Filgrastim is safe and effective, but it is cleared rapidly from the body (predominantly through the kidneys) and requires daily administration for up to 14 days. A pegylated form of filgrastim, pegfilgrastim, has been developed by attaching a polyethylene glycol molecule to filgrastim. Pegfilgrastim has an extended circulation half-life and self-regulating, patient-specific pharmacokinetics, making it possible to give the treatment as a single dose once per chemotherapy cycle. Clinical trials have shown that a single, subcutaneous dose of pegfilgrastim is as safe and effective as daily filgrastim injections in patients treated with myelosuppressive chemotherapy. In addition, a single, 6 mg fixed dose of pegfilgrastim per chemotherapy cycle is sufficient in adult patients, regardless of their body weight, making pegfilgrastim a simple, effective, and well-tolerated option for managing chemotherapy-induced neutropenia.

Antineoplastic Combined Chemotherapy Protocols↗