G-CSF administration following peripheral blood progenitor cell (PBPC) autograft in lymphoid malignancies: evidence for clinical benefits and reduction of treatment costs

Abstract

Summary:A rapid recovery of both neutrophils and platelets is commonly associated with PBPC autograft. 16,19 Thus, any further acceleration induced by growth factor adminisClinical value and costs of G-CSF administration following autograft with mobilized peripheral blood protration may be difficult to assess. In addition, the speed of BM recovery may be variably influenced by other congenitor cells (PBPC) were evaluated in two sequential groups of 20 patients each, treated for lymphoid neofounding factors, such as quantity of progenitor cells reinfused, type of conditioning regimen and previous treatplasms in the period February 1993 to January 1996. One group was given G-CSF (Filgrastim) (5 g/kg/day), ment. [20][21][22] These considerations explain the lack of a definite indication for the use of growth factor following starting on day +1 until ANC was Ͼ500/ l, the other received no G-CSF. All patients were conditioned with PBPC autograft. In this study we have evaluated the role of G-CSF during mitoxantrone 60 mg/m 2 + L-PAM 180 mg/m 2 and received large numbers of PBPC (median of 12 and hematological recovery in two sequential groups of patients autografted with PBPC in the early phases of their disease. 13 × 10 6 CD34 ؉ /kg, respectively). The median time to ANC Ͼ500/ l was 10 days in the G-CSF group vs 14Clinical features of the two groups were indistinguishable; all patients received the same submyeloablative treatment days in controls (P Ͻ 0.0001). G-CSF was associated with a slightly faster platelet recovery (11 vs 13 days to as conditioning and were autografted with large numbers of PBPC. The results indicate an accelerated hemopoietic plts Ͼ20 000/ l, P = 0.09). Median duration of fever (2.5 vs 5 days, P = 0.028), nonprophylactic antibiotics recovery and an overall better tolerability for the group receiving G-CSF following autograft compared to the con-(8 vs 11 days, P = 0.019), and post-transplant hospitalization (13 vs 16 days, P = 0.0028) were also significantly trol group. In addition, G-CSF administration was also associated with reduced costs for patient care during the reduced. The average cost per treatment in the G-CSF group amounted to about US$18 241 as compared to post-graft phase. Both observations support the use of growth factors even in spite of large numbers of PBPC US$21 868 in the control group, implying a cost reduction of approximately 16%. Thus, G-CSF reduced autografted. morbidity with cost containment, supporting its use even if autograft is performed with large quantities of PBPC.Patients and methods Keywords: PBPC autograft; post-graft recovery; G-CSF; economic evaluation Patients Forty patients with lymphoid malignancies were studied. They were autografted with peripheral blood progenitor The efficacy of growth factor administration to accelerate cells (PBPC) during the period between February 1993 and hemopoietic reconstitution following autologous bone marJanuary 1996; the first 20 patients (control group) had no row (BM) transplantation is well established. 1-7 Less hemo...

Optimal use of G-CSF administration after hematopoietic SCT

“…21 Three studies used a BSAbased dosing for filgrastim (50 mg/m 2 per day) or lenograstim (150 mg/m 2 per day), 11,17,27 whereas Lee et al 23 used a fixed dose of filgrastim (300 mg per day) in patients who weighed 70 kg or less and a weight-based dose (5 mg/kg per day) in patients heavier than 70 kg. The criteria for discontinuing G-CSF treatment after PBSCT differed significantly in various studies: when ANC 4500/ ml, 11,20,27 ANC 41000/ml, 21,22 ANC 41500/ml, 16,24 ANC 45000/ml, 19 or WBC 410 000/ml; 25 or after ANC 4500/ml for 2 28 or 3 17,26,29,30 consecutive days; or after ANC 41000/ ml for 2 consecutive days; 23 or after WBC 41000/ml for 3 consecutive days; 18 or was left to the treating physician. 10 Various PBSC mobilization protocols, conditioning regimens and prophylaxis therapies were used in these studies.…”

“…Various studies have evaluated the efficacy of using G-CSF in comparison to either placebo 11,16,17 or observation. 10,[18][19][20][21][22][23][24][25][26][27][28][29][30] These studies are summarized in Tables 1-3. Most of the studies involved patients with hematological malignancies (leukemia, Hodgkin's lymphoma, non-Hodgkin's lymphoma and multiple myeloma), with some also enrolling patients with nonhematological malignancies.…”

“…In most of the studies, ANC 4500/ml was achieved by day þ 9 to day þ 11 when G-CSF was used. The difference in days to neutrophil engraftment between the groups receiving or not receiving G-CSF ranged from 2 to 9.5 days, 10,11,[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] showing that the use of G-CSF was beneficial in terms of earlier neutrophil engraftment. In addition, several studies noted that even though the high number of CD34 þ cells infused correlated with earlier neutrophil engraftment, the benefit of using G-CSF was independent of the number of CD34 þ cells infused.…”

“…Time to neutrophil engraftment was significantly shorter when G-CSF was used after transplantation compared with observation or placebo in most of the studies. 10,11,17,18,[20][21][22][23][24][25][26][27][28][29][30] Only one retrospective and one prospective non-randomized study did not find a statistically significant difference in time to neutrophil engraftment between the group receiving G-CSF and the observation group. 19,21 As all the RCTs with a combined number of more than 100 patients in each group showed the beneficial effects of G-CSF on neutrophil engraftment, 10,11,16,17,[22][23][24]26,29 this was considered level 1A evidence.…”

“…G-CSF was administered on the basis of the patients' body weight in most studies at 5 mg/kg per day as either i.v. infusion or SQ injection 10,16,[18][19][20]22,[24][25][26]28,30 or at 10 mg/kg per day i.v. or SQ.…”