Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors

Abstract

Purpose: Pegteograstim (Neulapeg) is a recombinant human granulocyte colony-stimulating factor conjugated with methoxy-maleimide-polyethylene glycol. We conducted a single-arm study investigating its safety and noninferiority to conventional filgrastim in children and adolescents Materials and Methods: Patients younger than 21 years with solid tumors were eligible for the study. Pegteograstim was administered on day 7 of the fourth chemotherapy cycle. Toxicities were monitored, and the change in absolute neutrophil count was compared with that of the historic control (conventional filgrastim). This trial was registered at ClinicalTrials.gov as NCT02787876. Results: Thirty-two patients were enrolled. Adverse events possibly related to pegteograstim were musculoskeletal pain (n=3), skin nodule (n=1), paroxysmal cough (n=1), urticaria (n=2), rash (n=1), and itching (n=1). These adverse events were all grade 1 or 2. Duration of neutropenia (ANC<500/µL) was shorter in the pegteograstim group compared with the historic control (median 6.5 vs. 10 d, P=0.004). The time from day 0 to neutrophil recovery (ANC>500/µL) was shorter in the pegteograstim group (median 15 vs. 18 d, P=0.003). Conclusions: Pegteograstim is safe and shows comparable efficacy to conventional filgrastim in children and adolescents. Randomized controlled trials are needed to confirm its safety and efficacy.

Balancing Benefits and Risks: A Literature Review on Hypersensitivity Reactions to Human G-CSF (Granulocyte Colony-Stimulating Factor)

“…Nowadays, besides filgrastim and lenograstim, eight major G-CSF drugs are known: long-acting filgrastim-pegfilgrastim, lipegfilgrastim, mecapefilgrastim [14], empegfilgrastim [15], S/L-G-CSF biosimilar-balugrastim [16], leridistim, pegleridistim [17], and pegteograstim [18].…”

A multicenter phase II trial of primary prophylactic PEG‐rhG‐CSF in pediatric patients with solid tumors and non‐Hodgkin lymphoma after chemotherapy: An interim analysis

“…8 Previous studies demonstrated its cost-effectiveness, safety, and comparable efficacy to conventional rhG-CSF for the management of CIN in adults, 9 children, and adolescents. 10,11 Pegfilgrastim, a PEGylated form of rhG-CSF (analog of filgrastim), was approved for use in children to reverse CIN and reduce the incidence of neutropenia-associated infections. 12,13 Although PEG-rhG-CSF (Brand name, Jinyouli) was approved for marketing in China in March 2012, its use has been limited to Chinese adults.…”

“…Therefore, the plasma half‐life of PEG‐rhG‐CSF could be extended to up to 47 h, with preserved solubility, bioavailability, and stability 8 . Previous studies demonstrated its cost‐effectiveness, safety, and comparable efficacy to conventional rhG‐CSF for the management of CIN in adults, 9 children, and adolescents 10,11 …”

“… 8 Previous studies demonstrated its cost‐effectiveness, safety, and comparable efficacy to conventional rhG‐CSF for the management of CIN in adults, 9 children, and adolescents. 10 , 11 …”