Prophylactic PEG-rhG-CSF Reduces Febrile Neutropenia in Pediatric Hematological Malignancies Compared with Daily rhG-CSF.

Background

Febrile neutropenia (FN) is a major complication of chemotherapy in pediatric hematological malignancies. This study compared the efficacy and safety of prophylactic pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) versus daily short-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF).

Methods

This single-center, open-label, randomized controlled trial was conducted at a tertiary children's hospital in China. Pediatric patients (<18 years) with confirmed hematological malignancies (leukemia or lymphoma) were enrolled. A total of 138 chemotherapy cycles were randomized 2:1 to receive either a single dose of PEG-rhG-CSF (100 μg/kg, n = 86 cycles) or daily short-acting rhG-CSF (5 μg/kg/day, n = 45 cycles) after chemotherapy. The primary endpoint was FN incidence. Secondary endpoints included neutropenia incidence, FN duration, time to neutrophil recovery, blood product transfusions, hospital stay, and costs. Safety was assessed by monitoring adverse events (AEs) graded according to NCI CTCAE version 4.03.

Results

Baseline characteristics were comparable between groups. PEG-rhG-CSF significantly reduced the incidence of FN (59.3% vs. 77.7%, OR 0.42 (0.18-0.97), p = 0.046) compared to daily rhG-CSF. The median time to neutrophil recovery was 9.8 days (95% CI: 8.1-10.7) in the PEG-rhG-CSF group and 10.3 days (95% CI: 8.6-11.1) in the control group (p = 0.45). No significant differences were observed in FN duration, transfusions, hospital stay, or costs. Subgroup analyses showed PEG-rhG-CSF significantly reduced FN in non-Hodgkin lymphoma (57.4% vs. 83.3%, OR 0.27 (0.08-0.89), p = 0.032). A total of 12 AEs (9.9% overall, mainly bone pain) were observed, with no significant difference between groups and no infection-related deaths.

Conclusions

In this single-center, open-label trial, prophylactic single-dose PEG-rhG-CSF was associated with a lower incidence of FN compared to daily short-acting rhG-CSF. Safety profiles appeared broadly similar, but the sample size was insufficient to detect rare differences.