Pharmacologic rationale for early G-CSF prophylaxis in cancer patients and role of pharmacogenetics in treatment optimization

Crea, Francesco; Giovannetti, Elisa; Zinzani, Pier Luigi; Danesi, Romano

doi:10.1016/j.critrevonc.2008.10.014

Cited by 26 publications

(19 citation statements)

References 200 publications

(192 reference statements)

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“…Notably, 11.0% of the NHL patients in this NIS were reported having received lipegfilgrastim prophylaxis on the same day as chemotherapy not adhering to indicated administration schedule as per SPC of Lonquex ® . Lipegfilgrastim is intended to be administered approximately 24 hours after administration of chemotherapy …”

Section: Discussionsupporting

confidence: 58%

“…17 Lipegfilgrastim is intended to be administered approximately 24 hours after administration of chemotherapy. 24 As for reported AEs in this NIS, the incidences of back pain and bone pain are lower than expected, possibly due to underreporting, reflecting the NIS setting of this study. The incidences of the reported ADRs "leukocytosis" and "platelet count decreased" were slightly higher in this NIS than reported in the pivotal trials and stated on the SPC of Lonquex ® (incidence of leukocytosis: ≥0.1% <1.0%; incidence of platelet count decreased: ≥0.1% <1.0%).…”

Section: Discussion and Con Clus I Onmentioning

confidence: 62%

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Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Wolff¹,

Schulz²,

Losem

et al. 2018

European J of Haematology

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Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective was incidence of severe neutropenia, febrile neutropenia (FN), and neutropenia‐associated complications. Method NADIR was a national, multicenter, prospective NIS. Results Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 event of FN documented in 15 (4.5%) patients. Grade 3/4 infections were reported in 22 (6.5%) patients overall. Most frequently reported adverse events (AEs) related to lipegfilgrastim in total were bone pain (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none were attributable to lipegfilgrastim. Conclusion Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.

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Section: Discussionsupporting

confidence: 58%

Section: Discussion and Con Clus I Onmentioning

confidence: 62%

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Wolff¹,

Schulz²,

Losem

et al. 2018

European J of Haematology

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“…G-CSF = granulocyte colony-stimulating factor; GM-CSF = granulocyte-macrophage colony-stimulating factor; IL = interleukin; SCF = stem cell factor. Adapted from NIH (2012), Metcalf (2010), Crea et al (2009), and Kurtin (2011a). bone marrow comprises trabecular bone, stromal elements, hematopoietic cells, and elements of the bone marrow microenvironment (Table 1).…”

Section: Bone Marrow Physiology and Normal Hematopoiesismentioning

confidence: 99%

Myeloid Toxicity of Cancer Treatment

Kurtin¹

2012

JADPRO

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Myelotoxicity is one of the most common treatment-related adverse events for patients receiving systemic antineoplastic therapy or radiotherapy to bone marrow-producing regions. Myeloid cytopenias, including neutropenia, thrombocytopenia, and anemia, are the most common manifestations of treatment-related myelotoxicity and one of the most common reasons for dose modifications, dose delays, or discontinuation of therapy, potentially limiting therapeutic benefit. Risk factors for myelotoxicity can be broadly categorized into three types: disease-related, host-related, and treatmentrelated. Familiarity with factors predictive of high-risk febrile neutropenia, bleeding due to thrombocytopenia, and cardiopulmonary compromise due to anemia will provide the advanced practitioner (AP) in oncology with critical tools for rapid identification of patients at risk, prompt implementation of established guidelines for management, and avoidance of clinical deterioration. The AP in oncology is often the primary point of contact for management of cytopenias, including administration of myeloid growth factors, transfusion of blood products, and management of acute events such as neutropenic fevers. Each of these interventions requires familiarity with the risk and benefits of treatment. This article will review the physiology of the bone marrow, risk factors for cytopenias, and current guidelines and recommendations for prevention and treatment of myeloid toxicity of cancer treatment.

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“…However G-CSF is still the first-line drug for clinically increasing the neutrophil count in the blood. [3][4][5][6] Due to its short-life in blood, G-CSF has to be provided by frequent injection, which is inconvenient and painful for patients. To solve the problem, a different administration route or formulation development, including intranasal administration, [7][8][9] pulmonary delivery, [10][11][12] and oral administration, [13][14][15] is needed.…”

Section: Introductionmentioning

confidence: 99%

 Sustained-release G-CSF microspheres using a novel solid-in-oil-in-oil-in-water emulsion method

Liu¹,

Xiang²,

Jiang³

et al. 2012

IJN

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Background:The main treatments for cancers are still chemotherapy and radiotherapy for intermediate-stage cancer and terminal cancer. However, the therapeutic methods often result in a decreased neutrophilic granulocyte count and other side effects. In this study, in order to improve the neutrophilic granulocyte levels in the blood after radiotherapy and chemotherapy, we developed a sustained-release granulocyte colony-stimulating factor (G-CSF) microsphere formulation using a novel solid-in-oil-in-oil-in-water (S/O/O/W) emulsification method. Methods: G-CSF was loaded into dextran nanoparticles by freezing-induced phase separation, and then the G-CSF-loaded nanoparticles were encapsulated into sustained-release poly(lacticco-glycolic acid) microspheres using S/O/O/W emulsification. The control microspheres were also prepared through W/O/W emulsification. The performance of the two microsphere formulations was investigated both in vitro and in vivo. Results: The microspheres for the controlled release of G-CSF in a zero-order or near-zero-order pattern were provided for 2 weeks. The in vitro cumulative G-CSF release kept over 90% of its bioactivity, which was proved by a NFS-60 cell line growth assay. The microspheres of the control group fabricated by W/O/W emulsification maintained less then half of its bioactivity. The in vivo efficacy of microspheres made using the S/O/O/W method was higher than those using the W/O/W method. Conclusion: These results suggested that the microspheres prepared by the S/O/O/W method had increased neutrophil activity compared to those prepared by W/O/W.

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Pharmacologic rationale for early G-CSF prophylaxis in cancer patients and role of pharmacogenetics in treatment optimization

Cited by 26 publications

References 200 publications

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Myeloid Toxicity of Cancer Treatment

Sustained-release G-CSF microspheres using a novel solid-in-oil-in-oil-in-water emulsion method

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Pharmacologic rationale for early G-CSF prophylaxis in cancer patients and role of pharmacogenetics in treatment optimization

Cited by 26 publications

References 200 publications

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Myeloid Toxicity of Cancer Treatment

&nbsp;Sustained-release G-CSF microspheres using a novel solid-in-oil-in-oil-in-water emulsion method

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Sustained-release G-CSF microspheres using a novel solid-in-oil-in-oil-in-water emulsion method