%0 Journal Article
%T Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study.
%A Huang J
%A Zhu J
%A Jiang L
%A Xu J
%A Lin X
%A Chang J
%A Zhang X
%A Lu S
%A Sun F
%A Wang J
%A Que Y
%A Ye Z
%A Yang L
%A Yuan X
%A Cai W
%A Tian C
%A Wu Y
%A He X
%A Tang YL
%A Zhang Y
%J Front Pharmacol
%V 15
%N 0
%D 2024
%M 39086394
%F 5.988
%R 10.3389/fphar.2024.1419369
%X <B>UNASSIGNED: </B>High-intensity chemotherapy can cause life-threatening complications in pediatric patients. Therefore, this study investigated safety and efficacy of long-acting pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; Jinyouli®) in children undergoing high-intensity chemotherapy.<BR><B>UNASSIGNED: </B>Treatment-naive patients received post-chemotherapy PEG-rhG-CSF as primary prophylaxis for two cycles. The primary endpoints were drug-related adverse events (AEs) and bone pain scores. Secondary endpoints included grade 3-4 neutropenia, duration of neutropenia recovery, absolute neutrophil count changes, febrile neutropenia (FN), reduced chemotherapy intensity, antibiotic usage, and AE severity. The cost-effectiveness of PEG-rhG-CSF was compared with that of rhG-CSF (Ruibai®).<BR><B>UNASSIGNED: </B>Here, 307 and 288 patients underwent one and two PEG-rhG-CSF cycles, respectively. Ninety-one patients experienced drug-related AEs, primarily bone pain (12.7%). Moreover, Grade 3-4 neutropenia and FN were observed. Median FN durations were 3.0 days in both cycles. No drug-related delays were observed during chemotherapy. One patient experienced grade 4 neutropenia-induced reduction in chemotherapy intensity during cycle 2. In total, 138 patients received antibiotics. PEG-rhG-CSF exhibited superior cost-effectiveness compared to rhG-CSF.<BR><B>UNASSIGNED: </B>Our findings indicate that PEG-rhG-CSF is safe, efficient, and cost-effective in pediatric patients undergoing high-intensity chemotherapy, providing preliminary evidence warranting further randomized controlled trials.