Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial

Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. Methods A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received...

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Published inSupportive care in cancer Vol. 32; no. 1; p. 34
Main Authors Glaspy, John, Bondarenko, Igor, Burdaeva, Olga, Chen, Jianmin, Rutty, Dean, Li, Renshu, Wang, Shufang, Hou, Qingsong, Li, Simon
Format Journal Article
LanguageEnglish
Published Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2024
Springer
Springer Nature B.V
Subjects
Antibiotics
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - etiology
Cancer
Chemotherapy
Clinical outcomes
Clinical trials
Febrile Neutropenia - chemically induced
Febrile Neutropenia - drug therapy
Febrile Neutropenia - prevention & control
Female
Fever
Filgrastim - therapeutic use
Granulocyte Colony-Stimulating Factor
Growth factors
Humans
Medicine
Medicine & Public Health
Neutropenia
Neutrophils
Nursing
Nursing Research
Oncology
Pain Medicine
Polyethylene Glycols - therapeutic use
Prevention
Recombinant Proteins - therapeutic use
Rehabilitation Medicine
Efbemalenograstim alfa
Docetaxel /doxorubicin therapy
Granulocyte-colony stimulating factor
Breast cancer
Fusion protein
Febrile neutropenia
Online AccessGet full text
ISSN0941-4355
1433-7339
1433-7339
DOI10.1007/s00520-023-08176-6

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Abstract Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. Methods A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m 2 docetaxel + 60 mg/m 2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. Results For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p  = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p  = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. Conclusion Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy. Trial registration. NCT02872103, August 19, 2016.
AbstractList Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m.sup.2 docetaxel + 60 mg/m.sup.2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.
Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m docetaxel + 60 mg/m doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy. NCT02872103, August 19, 2016.
Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy.PURPOSEEvaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy.A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m2 docetaxel + 60 mg/m2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded.METHODSA phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m2 docetaxel + 60 mg/m2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded.For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy.RESULTSFor the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy.Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.CONCLUSIONEfbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.NCT02872103, August 19, 2016.TRIAL REGISTRATIONNCT02872103, August 19, 2016.
PurposeEvaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy.MethodsA phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m2 docetaxel + 60 mg/m2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded.ResultsFor the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy.ConclusionEfbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.Trial registration.NCT02872103, August 19, 2016.
Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. Methods A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m 2 docetaxel + 60 mg/m 2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. Results For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p  = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p  = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. Conclusion Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy. Trial registration. NCT02872103, August 19, 2016.
Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. Methods A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m.sup.2 docetaxel + 60 mg/m.sup.2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. Results For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. Conclusion Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy. Trial registration. NCT02872103, August 19, 2016.
ArticleNumber 34
Audience Academic
Author Wang, Shufang
Burdaeva, Olga
Bondarenko, Igor
Chen, Jianmin
Li, Simon
Glaspy, John
Li, Renshu
Rutty, Dean
Hou, Qingsong
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CitedBy_id crossref_primary_10_1200_OA_24_00074
crossref_primary_10_1186_s12885_024_12892_5
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Issue 1
Keywords Efbemalenograstim alfa
Docetaxel /doxorubicin therapy
Granulocyte-colony stimulating factor
Breast cancer
Fusion protein
Febrile neutropenia
Language English
License 2023. The Author(s).
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PublicationTitle Supportive care in cancer
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References LinkHCurrent state and future opportunities in granulocyte colony-stimulating factor (G-CSF)Support Care Cancer20223097067707710.1007/s00520-022-07103-5357393289225876
TheyabAAlsharifKFAlzahraniKJOyouniAAAHawsawiYMAlgahtaniMAlghamdiSAlshammaryAFNew insight into strategies used to develop long-acting G-CSF biologics for neutropenia therapyFront Oncol2023512102637710.3389/fonc.2022.1026377
Torres-ObrequeKMMeneguettiGPMuso-CachumbaJJFeitosaVASantosJHPMVenturaSPMRangel-YaguiCOBuilding better biobetters: from fundamentals to industrial applicationDrug Discov Today2022271658110.1016/j.drudis.2021.08.00934461236
AaproMSBohliusJCameronDADalLLDonnellyJPKearneyN2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumoursEur J Cancer201147183210.1016/j.ejca.2010.10.01321095116
European Medicines Agency (2022) Lonquex Product Information. Available at: https://www.ema.europa.eu/en/documents/product-information/lonquex-epar-product-information_en.pdf. Accessed 20.05.2023
KosakaYRaiYMasudaNPhase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapySupport Care Cancer2015231137114310.1007/s00520-014-2597-1255764334381099
KubistaEGlaspyJHolmesFABone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancerClin Breast Cancer2003339139810.3816/CBC.2003.n.00312636878
KirshnerJJMcDonaldMC3rdKruterFGuinigundoASVanniLMaxwellCLReinerMUpchurchTEGarciaJMorrowPKNOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastimSupport Care Cancer20182641323133410.1007/s00520-017-3959-229147854
TheyabAAlgahtaniMAlsharifKFHawsawiYMAlghamdiAAlghamdiAAkinwaleJNew insight into the mechanism of granulocyte colony-stimulating factor (G-CSF) that induces the mobilization of neutrophilsHematology202126162863610.1080/16078454.2021.196572534494505
U.S. Food & Drug Administration (2023) NEUPOGEN® (filgrastim) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103353s5198lbl.pdf. Accessed 20.05.2023
HolmesFAO'ShaughnessyJAVukeljaSJonesSEShoganJSavinMBlinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancerJ Clin Oncol200220372773110.1200/JCO.2002.20.3.72711821454
GreenMDKoelblHBaselgaJInternational Pegfilgrastim 749 Study GroupA randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapyAnn Oncol2003141293510.1093/annonc/mdg01912488289
SchwartzbergLSBhatGPegueroJEflapegrastim, a long-acting granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia: results of a phase III triallOncologist202010.1634/theoncologist.2020-0105332892688018299
Griffiths EA (2023) NCCN guidelines version 2.2023, Hematopoietic growth factors. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Available at:https://www.nccn.org/guidelines/guidelines-detail?category=3&id=1493. Accessed 10.04.2023
U.S. Food & Drug Administration (2022) ROLVEDON™ (eflapegrastim-xnst) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761148Orig1s000Corrected_lbl.pdf. Accessed 20.05.2023
MolineuxGPegfilgrastim: using pegylation technology to improve neutropenia support in cancer patientsAnticancer Drugs200314425926410.1097/00001813-200304000-0000212679729
CobbPWMoonYWMezeiKA comparison of eflapegrastim to pegfilgrastim in the management of chemotherapyinduced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): a phase 3 studyCancer Med202096234624310.1002/cam4.3227326872667476820
BondarenkoIGladkovOAElsaesserRBuchnerABiasPEfficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapyBMC Cancer20131338610.1186/1471-2407-13-386239450723751756
U.S. Food & Drug Administration (2021) NEULASTA® (pegfilgrastim) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125031s203lbl.pdf. Accessed 20.05.2023
PechtnerVKaranikasCAGarcía-PérezLEGlaesnerWA new approach to drug therapy: Fc-fusion technologyPrim Health Care2017725510.4172/2167-1079.1000255
GregorySASchwartzbergLSMoMSierraJVogelCEvaluation of reported bone pain in cancer patients receiving chemotherapy in pegfilgrastim clinical trials: a retrospective analysisCommunity Oncol2010729730810.1016/S1548-5315(11)70402-8
HuZHuangZHCenXBF-627, a G-CSF Dimer, Stimulated a more rapid neutrophil recovery in cyclophosphamide-treated monkeys compared to monomer rhG-CSFsBlood201011621148510.1182/blood.V116.21.1485.1485
TsuboiSHayamaTMiuraKUchiikeATsutsumiDYamauchiTHattaYOotsukaSHigher incidence of pegfilgrastim-induced bone pain in younger patients receiving myelosuppressive chemotherapy: a real-world experienceJ Pharm Health Care Sci202391210.1186/s40780-022-00272-9366276729832663
V Pechtner (8176_CR10) 2017; 7
A Theyab (8176_CR11) 2021; 26
PW Cobb (8176_CR18) 2020; 9
MS Aapro (8176_CR2) 2011; 47
LS Schwartzberg (8176_CR20) 2020
8176_CR1
SA Gregory (8176_CR14) 2010; 7
JJ Kirshner (8176_CR22) 2018; 26
8176_CR4
FA Holmes (8176_CR16) 2002; 20
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I Bondarenko (8176_CR19) 2013; 13
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G Molineux (8176_CR9) 2003; 14
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MD Green (8176_CR15) 2003; 14
A Theyab (8176_CR12) 2023; 5
E Kubista (8176_CR21) 2003; 3
Z Hu (8176_CR13) 2010; 116
Y Kosaka (8176_CR17) 2015; 23
S Tsuboi (8176_CR23) 2023; 9
KM Torres-Obreque (8176_CR7) 2022; 27
H Link (8176_CR8) 2022; 30
References_xml – reference: HuZHuangZHCenXBF-627, a G-CSF Dimer, Stimulated a more rapid neutrophil recovery in cyclophosphamide-treated monkeys compared to monomer rhG-CSFsBlood201011621148510.1182/blood.V116.21.1485.1485
– reference: U.S. Food & Drug Administration (2022) ROLVEDON™ (eflapegrastim-xnst) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761148Orig1s000Corrected_lbl.pdf. Accessed 20.05.2023
– reference: U.S. Food & Drug Administration (2021) NEULASTA® (pegfilgrastim) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125031s203lbl.pdf. Accessed 20.05.2023
– reference: TheyabAAlgahtaniMAlsharifKFHawsawiYMAlghamdiAAlghamdiAAkinwaleJNew insight into the mechanism of granulocyte colony-stimulating factor (G-CSF) that induces the mobilization of neutrophilsHematology202126162863610.1080/16078454.2021.196572534494505
– reference: GregorySASchwartzbergLSMoMSierraJVogelCEvaluation of reported bone pain in cancer patients receiving chemotherapy in pegfilgrastim clinical trials: a retrospective analysisCommunity Oncol2010729730810.1016/S1548-5315(11)70402-8
– reference: KosakaYRaiYMasudaNPhase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapySupport Care Cancer2015231137114310.1007/s00520-014-2597-1255764334381099
– reference: CobbPWMoonYWMezeiKA comparison of eflapegrastim to pegfilgrastim in the management of chemotherapyinduced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): a phase 3 studyCancer Med202096234624310.1002/cam4.3227326872667476820
– reference: KirshnerJJMcDonaldMC3rdKruterFGuinigundoASVanniLMaxwellCLReinerMUpchurchTEGarciaJMorrowPKNOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastimSupport Care Cancer20182641323133410.1007/s00520-017-3959-229147854
– reference: European Medicines Agency (2022) Lonquex Product Information. Available at: https://www.ema.europa.eu/en/documents/product-information/lonquex-epar-product-information_en.pdf. Accessed 20.05.2023
– reference: TsuboiSHayamaTMiuraKUchiikeATsutsumiDYamauchiTHattaYOotsukaSHigher incidence of pegfilgrastim-induced bone pain in younger patients receiving myelosuppressive chemotherapy: a real-world experienceJ Pharm Health Care Sci202391210.1186/s40780-022-00272-9366276729832663
– reference: LinkHCurrent state and future opportunities in granulocyte colony-stimulating factor (G-CSF)Support Care Cancer20223097067707710.1007/s00520-022-07103-5357393289225876
– reference: Griffiths EA (2023) NCCN guidelines version 2.2023, Hematopoietic growth factors. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Available at:https://www.nccn.org/guidelines/guidelines-detail?category=3&id=1493. Accessed 10.04.2023
– reference: U.S. Food & Drug Administration (2023) NEUPOGEN® (filgrastim) label information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103353s5198lbl.pdf. Accessed 20.05.2023
– reference: AaproMSBohliusJCameronDADalLLDonnellyJPKearneyN2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumoursEur J Cancer201147183210.1016/j.ejca.2010.10.01321095116
– reference: HolmesFAO'ShaughnessyJAVukeljaSJonesSEShoganJSavinMBlinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancerJ Clin Oncol200220372773110.1200/JCO.2002.20.3.72711821454
– reference: BondarenkoIGladkovOAElsaesserRBuchnerABiasPEfficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapyBMC Cancer20131338610.1186/1471-2407-13-386239450723751756
– reference: KubistaEGlaspyJHolmesFABone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancerClin Breast Cancer2003339139810.3816/CBC.2003.n.00312636878
– reference: TheyabAAlsharifKFAlzahraniKJOyouniAAAHawsawiYMAlgahtaniMAlghamdiSAlshammaryAFNew insight into strategies used to develop long-acting G-CSF biologics for neutropenia therapyFront Oncol2023512102637710.3389/fonc.2022.1026377
– reference: Torres-ObrequeKMMeneguettiGPMuso-CachumbaJJFeitosaVASantosJHPMVenturaSPMRangel-YaguiCOBuilding better biobetters: from fundamentals to industrial applicationDrug Discov Today2022271658110.1016/j.drudis.2021.08.00934461236
– reference: MolineuxGPegfilgrastim: using pegylation technology to improve neutropenia support in cancer patientsAnticancer Drugs200314425926410.1097/00001813-200304000-0000212679729
– reference: SchwartzbergLSBhatGPegueroJEflapegrastim, a long-acting granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia: results of a phase III triallOncologist202010.1634/theoncologist.2020-0105332892688018299
– reference: PechtnerVKaranikasCAGarcía-PérezLEGlaesnerWA new approach to drug therapy: Fc-fusion technologyPrim Health Care2017725510.4172/2167-1079.1000255
– reference: GreenMDKoelblHBaselgaJInternational Pegfilgrastim 749 Study GroupA randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapyAnn Oncol2003141293510.1093/annonc/mdg01912488289
– ident: 8176_CR1
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  publication-title: Support Care Cancer
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Snippet Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing...
Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive...
Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing...
PurposeEvaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing...
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StartPage 34
SubjectTerms Antibiotics
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - etiology
Cancer
Chemotherapy
Clinical outcomes
Clinical trials
Febrile Neutropenia - chemically induced
Febrile Neutropenia - drug therapy
Febrile Neutropenia - prevention & control
Female
Fever
Filgrastim - therapeutic use
Granulocyte Colony-Stimulating Factor
Growth factors
Humans
Medicine
Medicine & Public Health
Neutropenia
Neutrophils
Nursing
Nursing Research
Oncology
Pain Medicine
Polyethylene Glycols - therapeutic use
Prevention
Recombinant Proteins - therapeutic use
Rehabilitation Medicine
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Title Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial
URI https://link.springer.com/article/10.1007/s00520-023-08176-6
https://www.ncbi.nlm.nih.gov/pubmed/38103088
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Volume 32
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