Efficacy and Safety of Balugrastim Compared With Pegfilgrastim in Patients With Breast Cancer Receiving Chemotherapy

Volovăţ, Constantin; Gladkov, Oleg; Bondarenko, Igor; Barash, Steve; Buchner, Anton; Bias, Peter; Adar, Liat; Avisar, Noa

doi:10.1016/j.clbc.2013.10.001

Cited by 23 publications

(42 citation statements)

References 10 publications

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“…It appears that 3 mg/kg dose used in mice study is relatively high. This paper also reported that insertion of a G 4 SG 4 S linker could not improve the in vitro EC 50 . Another study reported the fusion of two tandem copies of exenatide to the N-terminus of albumin (E2HSA) [37].…”

Section: Glucagon-like Peptidementioning

confidence: 82%

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Recombinant Human Serum Albumin Fusion Proteins and Novel Applications in Drug Delivery and Therapy

Rogers¹,

Dong²,

Li³

et al. 2015

CPD

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Fusion proteins have been well-studied and widely applied in biopharmaceutics. Albumin fusion proteins are simple to construct, easy to purify, and stable to formulate. One main application of fusion protein is to extend the plasma half-life of therapeutic proteins and peptides. Albiglutide for diabetes treatment is the first albumin fusion protein drug approved by FDA. Balugrastim and other albumin fusion proteins have been evaluated in clinical trials. Taking advantage of the physiological functions of albumin, albumin fusion proteins can also been applied to act on an essential intracellular target and carry fatty acid-modified drugs. This novel approach makes it possible to co-deliver two different types of drug to one tumor cell for synergistic cytotoxicity.

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Section: Glucagon-like Peptidementioning

confidence: 82%

“…It is produced in yeast Saccharomyces cerevisiae with high yield and purity. A phase III clinical trial in breast cancer patients receiving chemotherapy has been completed to compare the efficacy and safety between balugrastim and pegfilgrastim [50].…”

Section: Granulocyte Colony Stimulating Factormentioning

confidence: 99%

Recombinant Human Serum Albumin Fusion Proteins and Novel Applications in Drug Delivery and Therapy

Rogers¹,

Dong²,

Li³

et al. 2015

CPD

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“…In general, the treatment-related AEs observed in this study were similar to those reported in the literature for myelosuppressive chemotherapy. [781114]…”

Section: Discussionmentioning

confidence: 99%

“…[1014] A multicenter, retrospective, observational study using pegfilgrastim reported bone and muscle pain in only 1.7% of patients. [11] The latter is supported by our findings, i.e.…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of Peg-grafeel™, a pegfilgrastim, for the prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia: A prospective, observational, postmarketing surveillance study in India

Talwar

Nirni

Mallavarapu

et al. 2017

South Asian J Cancer

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Background:A granulocyte colony-stimulating factor, pegfilgrastim, is efficacious though expensive for prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia. Biologics available and accessible today, having acceptable safety-efficacy profiles, require postapproval studies for better understanding of such drugs in clinical settings.Aim:This postmarketing surveillance study evaluated the safety of prophylactic Peg-grafeel™ (pegfilgrastim) in cancer patients with chemotherapy-induced neutropenia.Settings and Design:This prospective, noninterventional, single-arm, open-label study was conducted at 10 study sites in India.Methods:Patients received subcutaneous 6 mg Peg-grafeel™ approximately 24 h following chemotherapy as part of routine patient care.Statistical Analysis:Data were summarized descriptively.Results:The study included 250 patients (male: female = 36.4%:63.6%; median age, 54 [16–80] years). Most patients had Stage III (33.2%) or IV (41.6%) cancers and received cyclophosphamide (37.2%) and doxorubicin (31.6%) as chemotherapy. On an average, 4 Peg-grafeel™ doses were administered per patient. Treatment-emergent adverse events (AEs) were reported in 115 (46%) patients, the most common being vomiting (11.6%), pain (11.2%), nausea (8.4%), and constipation (8.4%). Peg-grafeel™-related AEs included pain (3.2%), asthenia (2.4%), and arthralgia (1.2%). Bone pain (0.4%) and extremity pain (1.2%) were rare. Grade 3/4 neutropenia and febrile neutropenia occurred in 4 (1.6%) and 3 (1.2%) patients, respectively. Serious AEs included vomiting (2.8%) and pyrexia (2%). No new safety concerns were identified. None of the five deaths was considered related to Peg-grafeel™.Conclusion:The overall safety profile of Peg-grafeel™ was consistent with the expected safety profile of pegfilgrastim in patients with advanced malignancies in a clinical setting.

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“…In contrast to PEG modifications, albumin fusion is easier to accomplish and provides a uniform substrate for G‐CSF without any additional chemical modifications. Additionally, albumin fusion may perform better by increasing the in vivo half‐life and reducing the side effects of the parent protein . Unfortunately, either albumin fusion or PEG modification may be accompanied by a decline in biological activity because of steric hindrance or closing the active site.…”

Section: Discussionmentioning

confidence: 99%

The Induction of Prolonged Myelopoietic Effects in Monkeys by GW003, A Recombinant Human Granulocyte Colony-Stimulating Factor Genetically Fused to Recombinant Human Albumin

Yang

Liu

et al. 2015

Journal of Pharmaceutical Sciences

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Efficacy and Safety of Balugrastim Compared With Pegfilgrastim in Patients With Breast Cancer Receiving Chemotherapy

Cited by 23 publications

References 10 publications

Recombinant Human Serum Albumin Fusion Proteins and Novel Applications in Drug Delivery and Therapy

Recombinant Human Serum Albumin Fusion Proteins and Novel Applications in Drug Delivery and Therapy

Safety and tolerability of Peg-grafeel™, a pegfilgrastim, for the prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia: A prospective, observational, postmarketing surveillance study in India

The Induction of Prolonged Myelopoietic Effects in Monkeys by GW003, A Recombinant Human Granulocyte Colony-Stimulating Factor Genetically Fused to Recombinant Human Albumin

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