F.F.H. Rutten

Randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating factor in patients with chemotherapy-related febrile neutropenia.

PURPOSE To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) used in addition to standard inpatient antibiotic therapy shortens the period of hospitalization due to chemotherapy-induced neutropenic fever. PATIENTS AND METHODS One hundred thirty-four patients with a hematologic (n = 47) or solid tumor (n = 87) who had severe neutropenia (< 0.5 x 10(9)/L) and fever (> 38.5 degrees C once or > 38 degrees C twice over a 12-hour observation period) were randomly assigned to receive GM-CSF 5 micrograms/kg/d (n = 65) or placebo (n = 69) in conjunction with broad-spectrum antibiotics for a minimum of 4 days and a maximum of 14 days. GM-CSF/placebo and antibiotics were stopped if the neutrophil count was greater than 1.0 x 10(9)/L and temperature less than 37.5 degrees C during 2 consecutive days, or for a leukocyte count > or = 10 x 10(9)/L, both followed by a 24-hour observation period (hospitalization period). RESULTS Compared with placebo, GM-CSF enhanced neutrophil recovery. Median neutrophil counts at day 4 were 2.5 x 10(9)/L (range, 0 to 25) in the GM-CSF arm and 1.3 x 10(9)/L (range, 0 to 9) in the placebo arm (P < .001). No significant difference was observed with regard to median number of days with less than 1.0 x 10(9)/L neutrophils (4 v 4) or days of fever (3 v 3). The median number of days patients were hospitalized while on study was comparable in the GM-CSF and placebo groups at 6 (range, 3 to 14) versus 7 (range, 4 to 14), respectively, according to an intention-to-treat analysis (P = .27). Quality-of-life scores in 90 patients demonstrated significant differences in favor of the placebo group. Hospital costs were significantly higher for GM-CSF-treated patients if GM-CSF was included in the price (median costs,

Cost-effectiveness and quality-of-life assessment of GM-CSF as an adjunct to intensive remission induction chemotherapy in elderly patients with acute myeloid leukaemia

4,140 [US] for GM-CSF v

Technology assessment of the Dutch Lung Transplantation program

590 for placebo; P < .05). CONCLUSION These results indicate that GM-CSF does not affect the number of days for resolution of fever or the hospitalization period for this patient group, although a significant effect of GM-CSF was observed on neutrophil recovery.

Peripheral blood progenitor cell transplantation mobilised by r-metHuG-CSF (Filgrastim); a Less costly alternative to autologous bone marrow transplantation

We conducted a prospective, randomized, multicentre clinical trial comparing the effects and costs of GM‐CSF as an adjunct to intensive chemotherapy in elderly patients with acute myeloid leukaemia (AML). The patients were randomized to either daunomycin–cytosine arabinoside (control arm: n = 161) or daunomycin–cytosine arabinoside with GM‐CSF (GM‐CSF arm: n = 157). The primary end‐point was the effect of GM‐CSF on the percentage of complete remissions (CR). Survival duration, disease‐free survival, quality of life and costs were evaluated separately.

An economic model to assess the savings from a clinical application of haematopoietic growth factors

The costs, effects, and cost-effectiveness of the Dutch Lung Transplantation program were assessed. The results show that lung transplantation is a very costly intervention that improves survival and quality of life. Costs per life-year and per QALY gained were, respectively, US

The costs of peripheral blood progenitor cell reinfusion mobilised by granulocyte colony-stimulating factor following high dose melphalan as compared with conventional therapy in multiple myeloma

90,000 and US

Factors to consider when designing phase III clinical trials involving economic evaluations

71,000.

Uitkomstenonderzoek: een definitie is dringend gewenst

In a retrospective study, we calculated the treatment costs of 63 patients who received either autologous bone marrow transplantation (ABMT) with recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF) (filgrastim) (n = 13) or without r-metHuG-CSF (n = 22) or alternatively, peripheral blood progenitor cell (PBPC) transplantation mobilised by r-metHuG-CSF (n = 28). The recovery of granulocytes, platelets and reticulocytes after PBPC was markedly accelerated as compared with ABMT with or without r-metHuG-CSF. The accelerated haematopoietic recovery was associated with a reduction in platelets and red blood cell transfusion requirements, with a reduction in episodes of fever and with earlier discharge from the hospital. This resulted in the average cost per treatment of the PBPC group being almost 30% lower than the treatment costs in the ABMT groups.

Productivity costs before and after absence from work: as important as common?

Patients receiving chemotherapy frequently develop fever and neutropenia. Haematopoietic growth factors (HGFs) may decrease the duration of such episodes or may prevent a febrile neutropenic episode. In this study we introduce a Markov type economic model for the hospital which calculates all relevant direct costs and savings of HGF therapy and may support decisions on HGF administration. A distinction is made between patients receiving intensive and standard chemotherapy schedules. Our results indicate that HGFs can induce savings in intensive chemotherapy and standard chemotherapy following neutropenic fever. Prophylactic administration of HGF is cost-effective if the risk of infection is considerable. The risk of infection depends on underlying malignancy, corresponding treatment modalities and the health condition of the patient. The model is meant as an analytical framework and should be used carefully, as not all benefits (e.g. benefits to the patients) are considered. These benefits may be balanced against the additional costs or savings resulting from the economic model.

Medical Consumption and Costs during a One-Year Follow-up of Patients with LUTS Suggestive of BPH in Six European Countries: Report of the TRIUMPH Study

In a retrospective study, we calculated the treatment costs of 26 patients, who received either high dose melphalan combined with granulocyte colony-stimulating factor (G-CSF; filgrastim)(n = 7) or without G-CSF (n = 11) or alternatively, peripheral blood progenitor cell reinfusion (PBPC) mobilised by G-CSF following high dose melphalan. In comparison with the control group, a shortening of the pancytopenic period and platelet recovery was noticed in the PBPC group. This resulted in a reduction in hospital costs, diagnostics, laboratory services, total parenteral nutrition and transfusions. The average costs per treatment in the PBPC group amounted to about US