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

The aim of this trial was to compare the severity of neutropenia, the frequ ency of hospital admission for fever or infection, and the use of antibioti cs among patients treated with a standard dose of lenograstim (263 mug/day of Euprotin) and others treated with half of this dose (131.5 mug/day) and the cost-effectiveness of each of the two doses. In this single-center stud y, 44 patients with solid tumors, who were all receiving standard-dose chem otherapy regimens following previous neutropenia or were at high risk of ne utropenia, were randomized to receive lenograstim at a dose of 263 mug or 1 31.5 mug daily in the first cycle and then crossed over to the alternate do se for the following cycle. Crossover to the alternate dose was repeated fo r 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 recei ved only 1 cycle. No statistically significant difference (P = 0.324) in AN C 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 a nd +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%, r espectively), 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 w ith the low dose (1 was admitted). ANC in both groups (standard and low dos es) was independent of chemotherapy line (first versus second or more). Len ograstim at a dose of 131.5 mug/day is as effective as the standard dose in limiting the severity of neutropenia and in preventing episodes of fever a nd hospital admissions after chemotherapy for solid tumors. The lower dose of lenograstim is cost-effective in neutropenia prophylaxis. Starting its a dministration on day +5 reduces costs while maintaining efficacy.