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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.

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单位： [1]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, China. [2]Department of Oncology, the First People's Hospital of Guangshui, Hubei, China. [3]Department of Oncology, Wuhan No. 1 Hospital, Wuhan, China. [4]Department of Oncology, Xiangyang No. 1 People's Hospital, Affiliated Hospital of Hubei University of Medicine, Hubei, China. [5]Department of Internal Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Henan, China. [6]Department of Oncology, Xiaogan Central Hospital, Xiaogan, China. [7]Department of Oncology, Wuhan Pulmonary Hospital, Wuhan, China. [8]Department of Oncology, Jingzhou Central Hospital, Hubei, China. [9]Department of Oncology, Huangshi Central Hospital, Huangshi, China. [10]Department of Oncology, Hubei Cancer Hospital, TongJi Medical College, Huazhong University of Science and Technology, Hubei, China. [11]Department of Radiation Oncology, Hubei Cancer Hospital, TongJi Medical College, Huazhong University of Science and Technology, Hubei, China. [12]Department of Oncology, The First College of Clinical Medical Science, China Three Gorges University, Yichang, China. [13]Institute of Molecular Medicine and Experimental Immunology, University Clinic of Rheinische Friedrich-Wilhelms-University, Bonn, Germany.

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Prophylactic 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.This 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.The 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.The 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.Copyright © 2022 Mei, Li, Wang, Qin, Cheng, Cheng, Dong, He, Li, Li, Tang, Wang, Xiao, Yang, Zhou, Wang, Huang, Hu and Li.

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出版当年[2021]版：

大类 | 3 区医学

小类 | 3 区肿瘤学

最新[2025]版：

大类 | 3 区医学

小类 | 4 区肿瘤学

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第一作者单位： [1]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei, China.

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