Biosimilar Granulocyte Colony-Stimulating Factor Is Effective in Reducing the Duration of Neutropenia After Autologous Peripheral Blood Stem Cell Transplantation

Cioch, Maria; Jawniak, Dariusz; Kotwica, K.; Wach, Małgorzata; Mańko, Joanna; Gorący, Aneta; Klimek, Piotr; Mazurkiewicz, E.; Jarosz, Piotr Michał; Hus, Marek

doi:10.1016/j.transproceed.2014.09.070

Cited by 7 publications

(4 citation statements)

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“…Synthesis: Following these procedures, 30 eligible studies were included in present review. Then potentially relevant studies were further assessed, excluding other-than-neutropenic-enterocolitis entities causing sepsis [ 20 , 21 , 22 , 23 , 24 , 25 , 26 ], pediatric subjects [ 27 ], and clinical trials [ 28 , 29 , 30 ]. After this literature review process, 19 papers were selected ( Figure 2 ).…”

Section: Literature Reviewmentioning

confidence: 99%

Neutropenic Enterocolitis and Sepsis: Towards the Definition of a Pathologic Profile

et al. 2021

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Background: Neutropenic enterocolitis (NE), which in the past was also known as typhlitis or ileocecal syndrome for the segment of the gastrointestinal tract most affected, is a nosological entity that is difficult to diagnose and whose pathogenesis is not fully known to date. Initially described in pediatric patients with leukemic diseases, it has been gradually reported in adults with hematological malignancies and non-hematological conditions, such as leukemia, lymphoma, multiple myeloma, aplastic anemia, and also myelodysplastic syndromes, as well as being associated with other immunosuppressive causes such as AIDS treatment, therapy for solid tumors, and organ transplantation. Therefore, it is associated with high mortality due to the rapid evolution in worse clinical pictures: rapid progression to ischemia, necrosis, hemorrhage, perforation, multisystem organ failure, and sepsis. Case report: A case report is included to exemplify the clinical profile of patients with NE who develop sepsis. Literature Review: To identify a specific profile of subjects affected by neutropenic enterocolitis and the entity of the clinical condition most frequently associated with septic evolution, a systematic review of the literature was conducted. The inclusion criteria were as follows: English language, full-text availability, human subjects, and adult subjects. Finally, the papers were selected after the evaluation of the title and abstract to evaluate their congruity with the subject of this manuscript. Following these procedures, 19 eligible empirical studies were included in the present review. Conclusions: Despite the recent interest and the growing number of publications targeting sepsis and intending to identify biomarkers useful for its diagnosis, prognosis, and for the understanding of its pathogenesis, and especially for multi-organ dysfunction, and despite the extensive research period of the literature review, the number of publications on the topic “neutropenic enterocolitis and sepsis” appears to be very small. In any case, the extrapolated data allowed us to conclude that the integration of medical history, clinical and laboratory data, radiological imaging, and macroscopic and histological investigations can allow us to identify a specific pathological profile.

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Section: Literature Reviewmentioning

confidence: 99%

Neutropenic Enterocolitis and Sepsis: Towards the Definition of a Pathologic Profile

et al. 2021

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“…In the Filgrastim Hexal cohort eight patients received more than four induction therapy cycles based on different therapeutic approaches in other medical institutions, in particularly abroad, before the patient presented in our center for further treatment. The median disease duration until PBSC collection was 5 (range, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] months. The upper range of 22 months resulted from the fact that some few patients underwent orthopedic surgery or local radiation before receiving systemic therapy.…”

Section: Patient Characteristicsmentioning

confidence: 99%

“…For prophylaxis of chemotherapy-induced neutropenia in cancer patients, several groups have demonstrated the efficiency of the biosimilar Zarzio/Filgrastim Hexal as well as its high grade of tolerance and broad clinical consistency with the reference product. [11][12][13][14][15] However, in previous studies PBSC mobilization outcomes were analyzed in heterogeneous and/or small cancer patient cohorts. [16][17][18][19][20] Moreover, no direct comparison of all three G-CSF variants-filgrastim, lenograstim, and the biosimilar Zarzio/Filgrastim Hexalin one single study population was performed so far.…”

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confidence: 99%

Comparison of biosimilar filgrastim, originator filgrastim, and lenograstim for autologous stem cell mobilization in patients with multiple myeloma

et al. 2017

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BACKGROUND Granulocyte–colony‐stimulating factor (G‐CSF) originators such as filgrastim (Neupogen) and lenograstim (Granocyte) are widely used for peripheral blood stem cell (PBSC) mobilization. In recent years, biosimilar agents have been approved for the same indications. The aim of this retrospective study was to compare the mobilization efficiency of the three G‐CSF variants originator filgrastim, lenograstim, and the biosimilar Filgrastim Hexal in a homogeneous group of multiple myeloma (MM) patients in first‐line therapy. STUDY DESIGN AND METHODS Overall mobilization data of 250 patients with MM were included. Of these patients, 74 (30%), 131 (52%), and 45 (18%) were mobilized with originator filgrastim, biosimilar Filgrastim Hexal, or lenograstim, respectively, at a dose of 5 to 10 µg/kg body weight subcutaneously starting from Day 5 after chemomobilization with CAD (cyclophosphamide, doxorubicin, dexamethasone) until completion of PBSC collection. RESULTS All but one patient reached the collection goal of a minimum of at least 2 × 106 CD34+ cells/kg body weight during a median of one (range, one to three) leukapheresis session. No significant differences in CD34+ mobilization and collection yields between the filgrastim‐mobilized (median, 10.5; range, 2.7‐40.4), Filgrastim Hexal–mobilized (median, 9.9; range, 0.2‐26.0), and lenograstim‐mobilized (median, 10.7; range, 3.1‐27.9 CD34+ cells × 106/kg body weight) patients were observed. CONCLUSION Concerning the clinically relevant efficiencies of PBSC mobilization and in terms of reaching the individual collection target, this retrospective study did not detect any significant differences between the three G‐CSF variants in the analyzed patient cohort.

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“…Lack of excitement by clinicians is underscored by the fact that none of the top-tier journals have published any of these clinical trials -one can easily imagine the editors' verdict of 'predictable -reject'. In the last year, reports from observational 'studies' lacking concurrent control groups have come forth about autologous mobilization and transplantation in children [15], autologous mobilization in adults [16][17][18], growth factor support after autologous transplantation in adults [18][19][20][21], and postchemotherapy neutropenia [22]; the impression from all was one of the overwhelmingly similar results as would have been expected with originator G-CSF. Manko et al [23 & ] report on a 1 : 1 randomized trial of Filgrastim vs. Zarxio G-CSF in autologous donor mobilization and transplantation which revealed no differences.…”

Section: Assessment Of Biosimilarity and Biosimilar Licensingmentioning

confidence: 99%

Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

Schulz

Bönig

2016

Current Opinion in Hematology

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Biosimilar Granulocyte Colony-Stimulating Factor Is Effective in Reducing the Duration of Neutropenia After Autologous Peripheral Blood Stem Cell Transplantation

Cited by 7 publications

References 10 publications

Neutropenic Enterocolitis and Sepsis: Towards the Definition of a Pathologic Profile

Neutropenic Enterocolitis and Sepsis: Towards the Definition of a Pathologic Profile

Comparison of biosimilar filgrastim, originator filgrastim, and lenograstim for autologous stem cell mobilization in patients with multiple myeloma

Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

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