Pegfilgrastim Provides Safe and Rapid Neutrophil Support in Patients with Acute Myeloid Leukemia (AML) Undergoing Myelosuppressive Chemotherapy.

Background: Administration of recombinant G-CSF has found extensive use in the support of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy. We retrospectively analyzed patients with acute myeloid leukemia (AML) who received either pegfilgrastim or lenograstim in this setting.

Patients and Methods: Unselected patients with AML according to FAB, age >18 years, performance status ECOG < 3, excluding pregnancy received at least one cycle of chemotherapy. On day 1 after chemotherapy has ended G-CSF treatment was initiated with pegfilgrastim 6 mg once per cycle or lenograstim 5 micg/kg b.w. until leucocyte counts (LC) raised > 1,000/micL. Primary objective was the difference in the time to elevating LC > 1,000/micL in each G-CSF treatment groups if LC nadired < 1,000/micL and the difference in the substitution of packed red blood (PRB) and platelets (PLT).

Results: Twenty-eight patients, 12 males and 16 females, aged median 61.4 years (range: 27–75 years) received 46 cycles. Six patients died due to the underlying disease. In four patients (two patients in the pegfilgrastim and two patients in the lenograstim group) G-CSF treatment failed to elevate LC > 1,000/micL. There was a difference in the time-to-recovery of leucocyte counts between pegfilgrastim 11.3 ± 3.8 days (range: 6 to 28 days) and lenograstim 13.3 ± 3.3 days (range: 6 to 22 days). The frequency of transfusions of PRB was 3.3 ± 2.6 in pegfilgrastim treated patients compared with 5.0 ± 2.9 in patients treated with lenograstim and the frequency of transfusions of PLT was 4.8 ± 2.5 vs. 6.0 ± 4.5. These differences received no statistical significance.

Conclusion: In this retrospective analysis unselected patients received myelodepressive chemotherapy because of acute myeloid leukemia. Both G-CSF showed adequate recovery of leucocyte counts with a faster increase in those patients to whom pegfilgrastim was administered. No statistical difference in the frequency of donation of human blood products was recognized. This retrospective study was limited because of the small number of patients included, thus these promising results need to be confirmed in a larger, prospective trial.