Efficacy and Safety for the Use of Half-Dosed Pegylated Granulocyte Colony-Stimulating Factors in Preventing Febrile Neutropenia During Chemotherapy in Patients With Malignant Tumors: A Multicenter, Open-Labeled, Single-Arm Phase 2 Trial

Abstract

BackgroundProphylactic granulocyte-colony stimulating factor (G-CSF) has been shown to effectively prevent febrile neutropenia (FN) and grade 3/4 neutropenia during myelosuppressive treatment. The present study reports the clinical efficacy and safety of the prophylactic use of G-CSF with a half dose for cancer patients with an intermediate risk of FN combined with ≥1 patient-specific risk during multiple chemotherapy.MethodsThis multicenter, one-arm, and open-label clinical study involved 151 patients [median age, 54 years old (range, 46.0–62.5); 38.4% female] with malignant tumors, including >20 different cancers. These patients underwent a total of 604 cycles of chemotherapy and received a half dose of PEG-rhG-CSF administration prior to each cycle.ResultsThe incidence rate of FN was 3.3% for this cohort during chemotherapy. Chemotherapy delay occurred in 6 (4.0%) patients for 12 (2.0%) cycles. Early termination of cancer treatment occurred in 14 (9.3%) patients. In this cohort, 23 (15.2%) patients required antibiotic use during courses of chemotherapy. A total of 28 (18.5%) patients experienced clear adverse effects during cancer treatment.ConclusionThe prophylactic PEG-rhG-CSF with a half dose can both efficaciously and safely prevent neutropenia for patients of diverse cancers with an intermediate risk of FN combined with ≥1 patient-specific risk during chemotherapy.

Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study

“…Both rhG-CSF and PEG-rhG-CSF induced the proliferation and maturation of neutrophils to reduce the incidence of FN, thereby presenting a therapeutic support strategy during intense-dose chemotherapy ( Mei et al, 2022 ). PEG-rhG-CSF has a prolonged plasma half-life compared to unmodified rhG-CSF.…”

Efficacy and safety of PEG-rhG-CSF versus rhG-CSF in preventing chemotherapy-induced-neutropenia in early-stage breast cancer patients

“…A Japanese phase II dose creep study in breast cancer patients showed that the efficacy of PEG-rhG-CSF was positively correlated with dose, but reached its peak efficacy at 3.6 mg [ 31 ]. A multicenter, single-arm, phase II clinical study by Qi Mei et al enrolled 151 patients of all cancer types with intermediate-risk chemotherapy for FN and ≥ 1 combined risk factors for half-dose PEG-rhG-CSF prophylaxis and found good results in reducing the incidence of FN (3.3%), delayed chemotherapy (4.0%), antibiotic use (15.2%), chemotherapy interruption (9.3%) and adverse events rate of 18.5%, which was well tolerated by patients [ 32 ]. Studies exploring the prophylactic effect of half-dose PEG-rhG-CSF have also demonstrated clinical benefits in some chemotherapy regimens [ 7 , 33 ].…”