A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia

Abstract

The aim of this trial was to compare the severity of neutropenia, the frequency of hospital admission for fever or infection, and the use of antibiotics among patients treated with a standard dose of lenograstim (263 microg/day of Euprotin) and others treated with half of this dose (131.5 microg/day) and the cost-effectiveness of each of the two doses. In this single-center study, 44 patients with solid tumors, who were all receiving standard-dose chemotherapy regimens following previous neutropenia or were at high risk of neutropenia, were randomized to receive lenograstim at a dose of 263 microg or 131.5 microg daily in the first cycle and then crossed over to the alternate dose for the following cycle. Crossover to the alternate dose was repeated for patients who received more than two cycles. Lenograstim was administered from day +5 to day +14. The absolute neutrophil count (ANC) was assessed on days +5, +8, +12 and +15 of each cycle. Statistical analysis was performed using a general lineal model for repeated samples. In all, 120 cycles were administered, with a median of 3 cycles (range 1-6). Only 4 patients received only 1 cycle. No statistically significant difference (P=0.324) in ANC was observed between standard-dose (mean 5.3, 10.7, 8.3, 11.4 x 10(9)/l) and low-dose (5.0, 8.6, 5.4, 7.5 x 10(9)/l) treatment at days +5, +8, +12 and + 15. Neutropenia grade III-IV was more common in patients receiving the low than in those receiving the standard dose of lenograstim (20% vs 12%, respectively), but the difference did not reach statistical significance (P=0.1). The incidence of fever and frequency of hospital admission were not affected by the dose of lenograstim: 3 patients presented with fever with the standard dose (all of those were admitted to hospital) and 2 patients with the low dose (1 was admitted). ANC in both groups (standard and low doses) was independent of chemotherapy line (first versus second or more). Lenograstim at a dose of 131.5 microg/day is as effective as the standard dose in limiting the severity of neutropenia and in preventing episodes of fever and hospital admissions after chemotherapy for solid tumors. The lower dose of lenograstim is cost-effective in neutropenia prophylaxis. Starting its administration on day +5 reduces costs while maintaining efficacy.

Cost benefit and clinical efficacy of low‐dose granulocyte colony‐stimulating factor after standard chemotherapy in patients with non‐Hodgkin's lymphoma

“…Although there have been several reports on doses of G‐CSFs for prophylaxis of postchemotherapy neutropenia, there is little information for patients with nonsolid tumors and no information for patients with NHL who were treated with rituximab (Toner et al. , 1998; Juan et al. , 2001; Hara et al.…”

“…There have been several reports on doses of G‐CSFs for prophylaxis of postchemotherapy neutropenia (Toner et al. , 1998; Juan et al. , 2001; Hara et al.…”

“…There have been several reports on doses of G-CSFs for prophylaxis of postchemotherapy neutropenia (Toner et al, 1998;Juan et al, 2001;Hara et al, 2005). In this clinical trial, we investigated differences among biologic activities of G-CSFs in settings for effectively increasing neutrophils and preventing serious infectious complications after chemotherapy in patients with NHL.…”

Low-dose filgrastim in patients with breast cancer treated with docetaxel, doxorubicin, and cyclophosphamide

“…Low-dose lenograstim has also proven to be more cost-effective than standard-dose lenograstim. 13,14 One study also demonstrated a trend toward less bone pain, a common adverse effect of CSFs, with low-dose lenograstim. 14 This study aims to retrospectively analyze the effectiveness of low-dose filgrastim, 150 μg/day, in patients receiving adjuvant treatment for node-positive or node-negative breast cancer with docetaxel (75 mg/ m 2 ), doxorubicin (50 mg/m 2 ), and cyclophosphamide (500 mg/m 2 ) given simultaneously every 21 days for a total of six cycles.…”

“…The decision to use low-dose filgrastim was based on the published effectiveness of low-dose lenograstim compared to standard-dose lenograstim in preventing febrile neutropenia and hospitalizations. 13,14 For convenience and prevention of wasting excess medication, a 150-μg/day filgrastim dose was chosen; two 150-μg filgrastim syringes can be prepared from a 300-μg filgrastim vial.…”