Multicenter postmarketing clinical study on using pegylated recombinant human gran-ulocyte-colony stimulating factor to prevent chemotherapy-induced neutropenia
10.3969/j.issn.1000-8179.2017.14.291
- VernacularTitle:聚乙二醇化重组人粒细胞刺激因子预防化疗后中性粒细胞减少症的多中心上市后临床研究
- Author:
Yuankai SHI
;
Jianping XU
;
Changping WU
;
Yan ZHANG
;
Junquan YANG
;
Tao ZHOU
;
Zheng LIU
;
Weidong MAO
;
Yiping ZHANG
;
Wei WANG
;
Zhonghe YU
;
Lin WU
;
Jianhua CHEN
;
Juan WANG
;
Yonghui AN
;
Jianhui CAI
;
Ming LIU
;
Zhendong CHEN
;
Qingshan LI
;
Chaoying REN
;
Zhiyong YANG
;
Baolan LI
;
Min ZHAO
;
Zhefeng LIU
;
Bin LIU
- Keywords:
pegylated recombinant human granulocyte-colonystimulating factor;
neutropenia;
tumor;
chemotherapy
- From:
Chinese Journal of Clinical Oncology
2017;44(14):679-684
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the efficacy and safety of using pegylated recombinant human granulocyte-colonystimulating factor (PEG-rhG-CSF) in preventing neutropenia in multiple chemotherapy cycles. Methods: A multicenter, prospective, open-label, singlearmstudy was designed. Patients with malignant tumors, such as lung, ovarian, and colorectal cancers, who received multiple cycles of chemotherapy with the prophylactic use of PEG-rhG-CSF for 2-4 consecutive cycles participated in the study. Results: After the prophylactic use of PEG-rhG-CSF, the incidence of grade IV neutropenia decreased from 4.76% (13/273) in the first cycle to 1.83% (5/273), 1.15% (2/174), and 2.08% (2/96) in subsequent cycles. Meanwhile, the incidence of grade III neutropenia decreased from 11.36% (31/ 273) in the first cycle to 6.23% (17/273), 2.87% (5/174), and 3.13% (3/96) in subsequent cycles. The incidence of febrile neutropenia (FN) during the first cycle was 0.73% (2/273). The duration of FN was 2 days in one case and 5 days in another case. FN was not observed during the second, third, or fourth cycle. After the secondary prophylactic use of PEG-rhG-CSF, the incidence of grade IV neutropenia decreased from 25% (7/28) to 3.57% (1/28), 0% (0/28), and 6.67% (1/15) in subsequent cycles. Meanwhile, the incidence of grade III neutropenia decreased from 71.43% (20/28) to 10.71% (3/28), 14.29% (4/28), and 0% (0/15) in subsequent cycles. The proportion of patients who received antibiotic therapy during the entire chemotherapy period was 10.48% (44/420). Conclusion: The application of PEG-rhG-CSF once per chemotherapy cycle can effectively reduce the occurrence of neutropenia in patients under multiple cycles of chemotherapy treatment with good safety.
