Efficacy, safety and proper dose analysis of PEGylated granulocyte colony-stimulating factor as support for dose-dense adjuvant chemotherapy in node positive Chinese breast cancer patients

Zhang, Fan; Linghu, Ruixia; Zhan, XingYang; Li, Ruisheng; Feng, Fan; Gao, Xudong; Zhao, Lei; Yang, Junlan

doi:10.18632/oncotarget.18145

Cited by 7 publications

(10 citation statements)

References 32 publications

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“…26,27 In a previous study, Zhang et al reported that the incidence of pain was 35% with 6 mg PEG-rhG-CSF. 13 In this study, 3 mg of PEG rhG-CSF contributed to a decrease in AEs. The incidence of pain in particular was reduced to only 15.7%.…”

Section: )mentioning

confidence: 51%

“…In addition, PEG‐rhG‐CSF still has its own adverse effects. In a previous study, a dose of 3 mg was effective in Chinese breast cancer patients who were scheduled to receive a dose‐dense every‐two‐week epirubicin/cyclophosphamide‐paclitaxel regimen 13 . On this basis, we investigated the efficiency of 3 mg for the preventive therapy of lung cancer patients scheduled to undergo chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…Zhang et al proposed a dose of 3 mg PEG rhG-CSF as a support for a dose-dense epirubicin/cyclophosphamide-paclitaxel (ddEC-P) regimen among Chinese breast cancer patients with positive auxiliary lymph nodes. 13 In a previous study of different doses and frequencies of PEG rhG-CSF in patients with CIN, a single dose of 60 μg/kg or 100 μg/kg produced a similar neutrophil response. 14 In addition, there has been a study on the efficacy and safety of 1.8, 3.6, and 6.0 mg pegfilgrastim after chemotherapy in breast cancer.…”

Section: Introductionmentioning

confidence: 89%

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Efficacy and safety of 3 mg pegylated recombinant human granulocyte colony‐stimulating factor as support to chemotherapy for lung cancer

Pan

et al. 2021

Thoracic Cancer

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Background: NCCN guidelines recommend a dose of 100 μg/kg or a fixed dose of 6 mg pegylated recombinant human granulocyte colony-stimulating factor (PEG rhG-CSF) for chemotherapy-induced neutropenia. However, a single dose of 60 μg/kg or 100 μg/kg produced a similar neutrophil response among patients with chemotherapy-induced neutropenia (CIN). Thus, this prospective randomized study was designed to investigate the efficacy of 3 mg PEG rhG-CSF in preventing acute lower respiratory tract infection (ALRTI) after chemotherapy. Methods: Patients with stage IIIB/IVA lung cancer who underwent chemotherapy were randomly divided into a (i) control group, and (ii) treatment group subject to 3 mg PEG rhG-CSF after chemotherapy. Patients in the control group were administered rhG-CSF (5 μg/kg) when decreased absolute neutrophil count (ANC) reached grade 3 of adverse events. The primary outcome was incidence of ALRTI, and the secondary outcomes included ANC, febrile neutropenia (FN), incidence of delayed chemotherapy, infection-related medical expenses and adverse reactions. Results: Compared with the control group, there was a significant decrease in the incidence of ALRTI (9.6% vs. 24.6%, p < 0.01), FN (1.7% vs. 7.3%, p < 0.001) and neutropenia (8.3% vs. 23.3%, p < 0.01) in the PEG-rhG-CSF group. The incidence of ALRTI was significantly correlated with the grade of CTCAE on ANC. The main adverse reactions of PEG-rhG-CSF were pain and fatigue, among which three cases showed pain of ≥ grade 3. The cost of infection-associated medical expenditure in the treatment group was greatly reduced compared with the control group (p < 0.001). Conclusions: ALRTI could well be prevented after prophylactic application of PEG-rhG-CSF (3 mg), and was related to the reduced neutropenia.

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Section: )mentioning

confidence: 51%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 89%

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Efficacy and safety of 3 mg pegylated recombinant human granulocyte colony‐stimulating factor as support to chemotherapy for lung cancer

Pan

et al. 2021

Thoracic Cancer

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“…Breast cancer represents one of the foremost threats to women’s health. 1 , 2 There are three major subtypes of human breast cancer: endocrine-related/dependent breast cancer (estrogen receptor positive), 3 , 4 human epidermal growth factor receptor 2 (HER2)-positive breast cancer 5 – 7 and triple-negative breast cancer (TNBC) (estrogen receptor negative, progesterone receptor negative and HER2 negative). 8 , 9 While there are effective treatment strategies for endocrine-related/dependent breast cancer (tamoxifen and fulvestrant), 10 – 13 and antibody treatments (trastuzumab) 14 – 16 can effectively attenuate the progression of HER2-positive breast cancer, there is no effective therapeutic intervention for TNBC.…”

Section: Introductionmentioning

confidence: 99%

MicroRNA-645 targets urokinase plasminogen activator and decreases the invasive growth of MDA-MB-231 triple-negative breast cancer cells

Du¹,

Lei²,

Han³

et al. 2018

OTT

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BackgroundUrokinase plasminogen activator (uPA) promotes the in vivo invasive growth of HCC cells by cleaving and activating matrix metalloproteinases (MMPs) to induce the destruction of the extracellular matrix of triple-negative breast cancer (TNBC) cells. The identification of microRNAs that target uPA and decrease uPA expression would be useful for attenuating the in vivo invasive growth of TNBC cells.Materials and methodsMicroRNA-645 (miR-645) was identified using an online tool (miRDB) as potentially targeting uPA; miR-645 inhibition of uPA was confirmed by western blot experiments. The effects of miR-645 on the in vivo invasive growth of TNBC cells were examined using an intrahepatic tumor model in nude mice, and the miR-645 mechanism of action was explored with MMP cleaving experiments.ResultsThrough virtual screening, we discovered that miR-645 potentially targeted the uPA 3′ untranslated region. This targeting was confirmed by western blot experiments and miR-645 lentiviral particle (LV-645) transduction that inhibited uPA expression in MDA-MB-231 TNBC cells. The LV-645 inhibition of uPA led to the decreased invasive growth of TNBC cells in nude mice. The mechanism data indicated that the uPA inhibition resulted in a decreased cleaving of the pro-MMP-9 protein.ConclusionTargeting uPA with miR-645 decreased the in vivo invasive growth of TNBC cells. These results suggest that miR-645 may represent a promising treatment strategy for TNBC.

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“…6 Neulasta (pegfilgrastim) has been approved and marketed in the European Union and in the United States since 2002, and its efficacy and safety have been demonstrated in a variety of tumor types and settings. [8][9][10][11] Globally, several pegfilgrastim biosimilars have been developed. [12][13][14][15][16] and approved by the US Food and Drug Administration, European Medicines Agency, and other regulators.…”

mentioning

confidence: 99%

Pharmacokinetics and Pharmacodynamics of Two Formulations of Pegylated Recombinant Human Granulocyte Colony‐Stimulating Factor in Healthy Chinese Subjects: An Open‐Label, Randomized, Parallel‐Design Bioavailability Study

et al. 2020

Clinical Pharm in Drug Dev

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Pegylated recombinant human granulocyte colony‐stimulating factor (PEG‐rhG‐CSF, pegfilgrastim) is a long‐acting derivative of recombinant human granulocyte colony‐stimulating factor with limited renal clearance and a longer half‐life. It is used for the prevention of febrile neutropenia, owing to its capacity to promote neutrophil recovery. In this study, the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of 2 formulations of PEG‐rhG‐CSF were evaluated in healthy Chinese subjects. Twenty‐four male subjects who received a single dose of subcutaneous PEG‐rhG‐CSF 100 µg/kg were randomized to either treatment A (3 mg/mL) or treatment B (1 mg/mL). Noncompartmental pharmacokinetic parameters of PEG‐rhG‐CSF were derived from serum concentration‐time data. In addition, absolute neutrophil count (ANC) as a pharmacodynamic maker, immunogenicity through antidrug antibody testing, and safety were evaluated. The mean area under the concentration‐time curve from time zero to the last quantifiable concentration (AUC0‐t) and the mean maximum concentration (Cmax) of PEG‐rhG‐CSF after treatment A were 5070 ng·h/mL and 125 ng/mL, respectively; these values were comparable to those measured after treatment B (5340 ng·h/mL and 123 ng/mL, respectively). The mean value of area under the △ANC (baseline‐adjusted ANC)‐time curve and the maximum △ANC values were 4380 × 109 h/L and 33.1 × 109/L, respectively, in the treatment A group, and 5170 × 109 h/L and 38.6 × 109/L, respectively, in the treatment B group. The pharmacokinetic and pharmacodynamic profiles were similar for the 2 PEG‐rhG‐CSF formulations following a single dose of 100 µg/kg. The safety and immunogenicity profiles were also similar, with no significant differences. The dose adjustment of PEG‐rhG‐CSF was not considered necessary for formulation transformation.

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Efficacy, safety and proper dose analysis of PEGylated granulocyte colony-stimulating factor as support for dose-dense adjuvant chemotherapy in node positive Chinese breast cancer patients

Cited by 7 publications

References 32 publications

Efficacy and safety of 3 mg pegylated recombinant human granulocyte colony‐stimulating factor as support to chemotherapy for lung cancer

Efficacy and safety of 3 mg pegylated recombinant human granulocyte colony‐stimulating factor as support to chemotherapy for lung cancer

MicroRNA-645 targets urokinase plasminogen activator and decreases the invasive growth of MDA-MB-231 triple-negative breast cancer cells

Pharmacokinetics and Pharmacodynamics of Two Formulations of Pegylated Recombinant Human Granulocyte Colony‐Stimulating Factor in Healthy Chinese Subjects: An Open‐Label, Randomized, Parallel‐Design Bioavailability Study

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