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学科主题: 临床医学
题名:
Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study
作者: Shi, Yuan-Kai1,2; Chen, Qiang6; Zhu, Yun-Zhong3; He, Xiao-Hui1,2; Wang, Hua-Qing7; Jiang, Ze-Fei4; Chang, Jian Hua9; Liu, Yun-Peng11; Wang, An-Lan12; Luo, De-Yun13; Zhang, Yang14; Ke, Xiao-Yan5; Li, Wei-Lian8; Zhang, Wei-Jing4; Wang, Xiu-Wen15; Zhang, Yi-Ping16; Wang, Jian-Min10; Liu, Xiao-Qing4
关键词: chemotherapy ; clinical trial ; filgrastim ; neutropenia ; polyethylene glycol
刊名: ANTI-CANCER DRUGS
发表日期: 2013-07-01
DOI: 10.1097/CAD.0b013e3283610b5d
卷: 24, 期:6, 页:641-647
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Pharmacology & Pharmacy
研究领域[WOS]: Oncology ; Pharmacology & Pharmacy
关键词[WOS]: NON-HODGKINS-LYMPHOMA ; SINGLE-ADMINISTRATION PEGFILGRASTIM ; FEBRILE NEUTROPENIA ; BREAST-CANCER ; DOUBLE-BLIND ; CYCLE ; RISK ; 1ST ; ADJUNCT ; EVENTS
英文摘要:

The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 mu g/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 mu g/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5x10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0x10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 g/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 g/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens. (C) 2013 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

语种: 英语
所属项目编号: 2008ZX09312-020 ; 2012ZX09303012 ; 96-901-01-53 ; Z111102071011001
项目资助者: CSPC Baike (Jinan) Biopharmaceutical Co. Ltd. ; Chinese National Science and Technology Major Project on Key New Drug Creation ; Chinese National Key Scientific and Technological Projects ; Beijing Municipal Science &amp ; Technology Commission, P.R. China
WOS记录号: WOS:000323214000012
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59722
Appears in Collections:北京大学第三临床医学院_血液内科_期刊论文

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作者单位: 1.Peking Union Med Coll, Canc Inst Hosp, Dept Med Oncol, Beijing 100021, Peoples R China
2.Chinese Acad Sci, Beijing Key Lab Clin Study Anticancer Mol Target, Beijing 100864, Peoples R China
3.Beijing Chest Hosp, Dept Med Oncol, Beijing, Peoples R China
4.307 Hosp, Dept Med Oncol, Beijing, Peoples R China
5.Peking Univ, Hosp 3, Dept Hematol, Beijing 100871, Peoples R China
6.Fujian Prov Canc Hosp, Dept Med Oncol, Fuzhou, Peoples R China
7.Tianjin Med Univ, Canc Inst & Hosp, Dept Med Oncol, Tianjin, Peoples R China
8.Tianjin Peoples Hosp, Dept Med Oncol, Tianjin, Peoples R China
9.Fudan Univ, Ctr Canc, Dept Med Oncol, Shanghai 200433, Peoples R China
10.Changhai Hosp, Dept Hematol, Shanghai, Peoples R China
11.China Med Univ, Affiliated Hosp 1, Dept Med Oncol, Shenyang, Peoples R China
12.Hunan Canc Hosp, Dept Med Oncol, Changsha, Peoples R China
13.Sichuan Univ, West China Hosp, Dept Med Oncol, Chengdu 610064, Peoples R China
14.Dalian Med Univ, Hosp 2, Dept Med Oncol, Dalian, Peoples R China
15.Shandong Univ, Qilu Hosp, Dept Med Oncol, Jinan 250100, Peoples R China
16.Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Peoples R China

Recommended Citation:
Shi, Yuan-Kai,Chen, Qiang,Zhu, Yun-Zhong,et al. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study[J]. ANTI-CANCER DRUGS,2013,24(6):641-647.
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