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

oleh: Qi Mei, Xiaoyu Li, Runkun Wang, Kai Qin, Yi Cheng, Weiting Cheng, Youhong Dong, Zhen He, Jun Li, Ming Li, Xi Tang, Xudong Wang, Xuxuan Xiao, Bin Yang, Yajuan Zhou, Rui Wang, Qiao Huang, Guangyuan Hu, Jian Li

Format: Article
Diterbitkan: Frontiers Media S.A. 2022-04-01

Deskripsi

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.