An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy

Zhang, Wei; Jiang, Zhiwei; Li, Chanjuan; Xia, Jielai

doi:10.1007/s12032-015-0537-7

Cited by 20 publications

(40 citation statements)

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“…Seventeen publications reported RCT data: five congress abstracts [ 34 , 42 , 47 – 49 , 60 ], four full foreign language publications with an English abstract [ 52 , 56 , 58 , 59 ], and eight full English language publications [ 33 , 35 , 36 , 45 , 51 , 53 , 55 , 57 ]. Publications reported data from RCTs conducted in China ( n = 6) [ 51 , 52 , 56 – 59 ], multiple countries worldwide ( n = 3) [ 35 , 36 , 53 ], Russia ( n = 2) [ 34 , 48 , 60 ], India ( n = 2) [ 47 , 49 ], Europe ( n = 1) [ 42 ], Korea ( n = 1) [ 45 ], Italy ( n = 1) [ 33 ], and the United States ( n = 1) [ 55 ].…”

Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia

et al. 2018

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IntroductionShort- and long-acting granulocyte-colony stimulating factors (G-CSFs) are approved for the reduction of febrile neutropenia. A systematic literature review was performed to identify randomized controlled trials (RCTs) and non-RCTs reporting the use of G-CSFs following chemotherapy treatment.MethodsMedline®/Medline in-process, Embase®, and the Cochrane Library were searched for studies published between January 2003 and June 2016. A hand-search of relevant conference proceedings was conducted for meetings held between 2012 and 2016. Eligible studies were restricted to those reporting a direct, head-to-head comparison of short- versus long-acting G-CSFs for reduction of chemotherapy-induced febrile neutropenia. Risk-of-bias assessments were performed for full publications only.ResultsThe search strategy yielded 4044 articles for electronic screening. Thirty-six publications were evaluated for the meta-analysis: 11 of 12 RCTs and 2 of 24 non-RCTs administered doses of the short-acting G-CSF filgrastim for ≥ 7 days. In RCT studies, there was no statistically significant difference in outcomes of interest between short- and long-acting G-CSFs. In non-RCTs, the overall risk was lower with long-acting G-CSF than with short-acting G-CSF for incidence of febrile neutropenia [overall relative risk (RR) = 0.67, P = 0.023], hospitalizations (overall RR = 0.68, P < 0.05), and chemotherapy dose delays (overall RR = 0.68, P = 0.020).ConclusionsOverall, the weight of evidence from RCTs indicates little difference in efficacy between the short- and long-acting G-CSFs if dosed according to recommended guidelines. There is some evidence for greater efficacy for long-acting G-CSFs in non-RCTs, which may be a result of under-dosing of short-acting G-CSFs in general practice in real-world usage.FundingHospira Inc, which was acquired by Pfizer Inc in September 2015, and Pfizer Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0798-6) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia

et al. 2018

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“…However, we did not observe any differences between L-G-CSF and S-G-CSF drugs. In this regard, some earlier patient trials have indicated that lenograstim drug was more effective than filgrastim in terms of the SN and SDN incidence [11,13,16], but differences between L-G-CSF and S-G-CSF drugs were not statistically significant. Some of the tentative reasons for the lack of a difference could be because of few patient data points and other factors like the chemotherapy regimen and cancer type differentially impacting the incidence rate of SN and DSN.…”

Section: Discussionmentioning

confidence: 93%

“…However, there have been some reports about the varying effects of S-G-CSF and L-G-CSF drugs in reducing FN and SN incidence rate after chemotherapy [11][12][13][14]. Multiple studies have indicated that pegfilgrastim is more effective than filgrastim based on ANC evaluation in patients receiving myelosuppressive chemotherapy [11,12,[15][16][17][18][19][20][21][22][23][24][25][26][27][28]. Thus, there are differing accounts about the benefits of S-G-CSF and L-G-CSF drugs and the subject requires further clarification.…”

Section: Introductionmentioning

confidence: 99%

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Comparing the efficacy and safety of long and short acting drugs targeting Granulocyte Colony-stimulating Factor in cancer patients after chemotherapy: A systematic review and meta-analysis of randomized controlled trials

Zhang

Wang

Liu

et al. 2020

Preprint

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Background: Granulocyte Colony-Stimulating Factor (G-CSF) is widely targeted for the treatment of cancer patients after chemotherapy. However, the safety and efficacy comparisons of long (L-G-CSF) and short-acting (S-G-CSF) drugs targeting G-CSF are still lacking. Thus, herein, we attempted to address this issue by undertaking meta-analyses of existing studies using different drugs targeting G-CSF. Methods: The relevant studies were identified by searching Pubmed, EMBASE, Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases. Febrile neutropenia (FN) was considered as the direct primary efficacy endpoint, while severe neutropenia (SN) and the duration of severe neutropenia (DSN) served as secondary efficacy endpoints. Bone pain (BP) was used as an indicator for safety analysis. All identified trials were assessed using the Cochrane Collaboration Tool and meta-analysis was performed using Review Manager 5.3 and STATA 15.0 software. Results: Our meta-analyses based on 20 randomized controlled trials (RCTs) revealed that L-G-CSF drugs including empegfilgrastim, L-G-CSF biosimilars, and pegfilgrastim were overall better in reducing FN incidence compared to S-G-CSF drugs like filgrastim and lenograstim (odds ratio [OR]=0.70, 95% confidence interval [CI]=0.54~0.92, p=0.01). Specifically, filgrastim resulted in higher FN risk than pegfilgrastim (OR=0.66, 95% CI=0.50~0.87, p=0.004). However, L-G-CSF and S-G-CSF drugs revealed no differences in terms of SN, DSN, and BP endpoints (SN: OR=0.92, 95% CI=0.78~1.09, p=0.33; DSN: RR=-0.04, 95% CI=0.17~0.09, p=0.53; BP: OR=0.87, 95% CI=0.67~1.14, p=0.31). Conclusion: Based on our analyses, L-G-CSF drugs in comparison to S-G-CSF drugs resulted in significantly lower FN incidence, but no difference in terms of the SN, DSN, and BP endpoints.

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“…An illustrative example of success in chemical site-selective PEGylation is the case of Neulasta ® , which is an N-terminally mono-PEGylated granulocyte colony-stimulating factor bearing a 20-kDa PEG (Molineux, 2004). The improved pharmacokinetic behavior of this biopharmaceutical allows administration only once per chemotherapy cycle compared to the first generation, Neupogen ® , which is administered daily (Cesaro et al, 2013;Zhang et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

From Synthesis to Characterization of Site-Selective PEGylated Proteins

et al. 2019

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Covalent attachment of therapeutic proteins to polyethylene glycol (PEG) is widely used for the improvement of its pharmacokinetic and pharmacological properties, as well as the reduction in reactogenicity and related side effects. This technique named PEGylation has been successfully employed in several approved drugs to treat various diseases, even cancer. Some methods have been developed to obtain PEGylated proteins, both in multiple protein sites or in a selected amino acid residue. This review focuses mainly on traditional and novel examples of chemical and enzymatic methods for site-selective PEGylation, emphasizing in N-terminal PEGylation, that make it possible to obtain products with a high degree of homogeneity and preserve bioactivity. In addition, the main assay methods that can be applied for the characterization of PEGylated molecules in complex biological samples are also summarized in this paper.

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An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy

Cited by 20 publications

References 33 publications

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia

Comparing the efficacy and safety of long and short acting drugs targeting Granulocyte Colony-stimulating Factor in cancer patients after chemotherapy: A systematic review and meta-analysis of randomized controlled trials

From Synthesis to Characterization of Site-Selective PEGylated Proteins

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