prikaz prve stranice dokumenta A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy
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A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy
Journal of Pediatric Hematology/Oncology, 41 (2019), 7; 525-531. https://doi.org/10.1097/mph.0000000000001542
Federman, Noah; Dragomir, Monica D.; Kizyma, Zoryana; Roganovic, Jelena; Bias, Peter; Lammerich, Andreas; Ben Arie, Zipi R.; Zou, Linglong; Hoehn, Gerald; Buchner, Anton

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Federman, N., Dragomir, M. D., Kizyma, Z., Roganovic, J., Bias, P., Lammerich, A. ... Buchner, A. (2019). A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy. Journal of Pediatric Hematology/Oncology, 41. (7), 525-531. doi: 10.1097/mph.0000000000001542

Federman, Noah, et al. "A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy." Journal of Pediatric Hematology/Oncology, vol. 41, br. 7, 2019, str. 525-531. https://doi.org/10.1097/mph.0000000000001542

Federman, Noah, Monica D. Dragomir, Zoryana Kizyma, Jelena Roganovic, Peter Bias, Andreas Lammerich, Zipi R. Ben Arie, Linglong Zou, Gerald Hoehn i Anton Buchner. "A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy." Journal of Pediatric Hematology/Oncology 41, br. 7 (2019): 525-531. https://doi.org/10.1097/mph.0000000000001542

Federman, N., et al. (2019) 'A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy', Journal of Pediatric Hematology/Oncology, 41(7), str. 525-531. doi: 10.1097/mph.0000000000001542

Federman N, Dragomir MD, Kizyma Z, Roganovic J, Bias P, Lammerich A, i sur.. A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy. Journal of Pediatric Hematology/Oncology [Internet]. 2019. [pristupljeno 07.05.2024.];41(7):525-531. doi: 10.1097/mph.0000000000001542

N. Federman, et al., "A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy", Journal of Pediatric Hematology/Oncology, vol. 41, br. 7, str. 525-531, 2019. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:184:771828. [Citirano: 07.05.2024.]

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Naslov (engleski)A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy
AutorNoah Federman
AutorMonica D. Dragomir
AutorZoryana Kizyma
AutorJelena Roganovic
AutorPeter Bias
AutorAndreas Lammerich
AutorZipi R. Ben Arie
AutorLinglong Zou
AutorGerald Hoehn
AutorAnton Buchner
Autorova ustanovaSveučilište u Rijeci
Medicinski fakultet
(Katedra za pedijatriju)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Onkologija
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Pedijatrija
Sažetak (engleski)
This phase 2, multicenter, open-label trial investigated the safety and tolerability of tbo- filgrastim in pediatric patients receiving myelosuppressive chemotherapy. In total, 50 patients 1 month to below 16 years of age with solid tumors without bone marrow involvement were stratified into 3 age groups (2 infants, 30 children, 18 adolescents) and prophylactically administered tbo-filgrastim 5 µg/kg body weight once daily subcutaneously. The administration started after the last chemotherapy treatment in week 1 of the first cycle and continued until the expected neutrophil nadir had passed, and the neutrophil count had recovered to 2.0×10/L. The primary endpoint was safety and tolerability of tbo-filgrastim ; secondary endpoints included efficacy. The mean (SD) number of doses administered was 9.2 (2.83) in children and 7.3 (1.88) in adolescents. Serious treatment-emergent adverse events were reported in 24% of patients ; the most common were febrile neutropenia (FN) (12%), anemia (8%), and thrombocytopenia (8%). Nine patients (18%) experienced mild treatment- related treatment-emergent adverse events ; the most common were musculoskeletal and connective tissue disorders (8%). No deaths or withdrawals occurred. The incidence of severe neutropenia (SN) was 52% and the mean (SD) duration of SN was 1.8 (2.21) days ; FN incidence was 26%. A daily dose of tbo-filgrastim 5 μg/kg body weight administered to pediatric patients demonstrated a safety profile consistent with the safety profile in adult patients. The incidence of FN was on the lower end of the range reported in the literature and the SN results provide supportive data on the efficacy of tbo-filgrastim in pediatric patients.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran - međunarodna recenzija
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaJournal of Pediatric Hematology/Oncology
Brojčani podacivol. 41, br. 7, str. 525-531
p-ISSN1077-4114
DOIhttps://doi.org/10.1097/mph.0000000000001542
URN:NBNurn:nbn:hr:184:771828
Datum objave publikacije2019
URL dokumentahttp://bib.irb.hr/1048377
Vrsta resursaTekst
Prava pristupaZatvoreni pristup
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Datum i vrijeme pohrane2022-02-09 11:35:34