Application of pegylated recombinant human granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia in patients with lymphoma: a prospective, multicenter, open-label clinical trial
10.3760/cma.j.issn.0253-2727.2017.10.001
- VernacularTitle: 应用聚乙二醇化重组人G-CSF预防淋巴瘤患者化疗后中性粒细胞减少：一项前瞻、多中心、开放性临床研究
- Author:
Huiqiang HUANG
1
;
Bing BAI
;
Yuhuan GAO
;
Dehui ZOU
;
Shanhua ZOU
;
Huo TAN
;
Yongping SONG
;
Zhenyu LI
;
Jie JIN
;
Wei LI
;
Hang SU
;
Yuping GONG
;
Meizuo ZHONG
;
Yuerong SHUANG
;
Jun ZHU
;
Jinqiao ZHANG
;
Zhen CAI
;
Qingliang TENG
;
Wanjun SUN
;
Yu YANG
;
Zhongjun XIA
;
Hailin CHEN
;
Luoming HUA
;
Yangyi BAO
;
Ning WU
Author Information
1. Sun Yat-Sen University Cancer Center, Guangzhou 510060, China
- Publication Type:Journal Article
- Keywords:
Granulocyte colony-stimulating factor;
Polyethylene glycols;
Lymphoma;
Neutropenia;
Protective agent
- From:
Chinese Journal of Hematology
2017;38(10):825-830
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in prophylaxis neutropenia after chemotherapy in patients with lymphoma.
Methods:This was a multicenter, single arm, open, phase Ⅳ clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of Ⅲ/Ⅳ grade neutropenia and febrile neutropenia (FN) after each chemotherapy cycle. Meanwhile the rate of antibiotics application during the whole period of chemotherapy was observed.
Results:①Among the 410 patients, 8 cases (1.95%) were contrary to the selected criteria, 35 cases (8.54%) lost, 19 cases (4.63%) experienced adverse events, 12 cases (2.93%) were eligible for the termination criteria, 15 cases (3.66%) develpoed disease progression or recurrence, thus the rest 321 cases (78.29%) were into the Per Protocol Set. ②During the first to fourth treatment cycles, the incidences of grade Ⅳ neutropenia after prophylactic use of PEG-rhG-CSF were 19.14% (49/256) , 12.5% (32/256) , 12.18% (24/197) , 13.61% (20/147) , respectively. The incidences of FN were 3.52% (9/256) , 0.39% (1/256) , 2.54% (5/197) , 2.04% (3/147) , respectively. After secondary prophylactic use of PEG-rhG-CSF, the incidences of Ⅳ grade neutropenia decreased from 61.54% (40/65) in the screening cycle to 16.92% (11/65) , 18.46% (12/65) and 20.75% (11/53) in 1-3 cycles, respectively. The incidences of FN decreased from 16.92% (11/65) in the screening cycle to 1.54% (1/65) , 4.62% (3/65) , 3.77% (2/53) in 1-3 cycles, respectively. ③The proportion of patients who received antibiotic therapy during the whole period of chemotherapy was 34.39% (141/410) . ④The incidence of adverse events associated with PEG-rhG-CSF was 4.63% (19/410) . The most common adverse events were bone pain[3.90% (16/410) ], fatigue (0.49%) and fever (0.24%) .
Conclusion:During the chemotherapy in patients with lymphoma, the prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade Ⅲ/Ⅳ neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve its cure rate.
