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
No public access
Scientific paper - Original scientific paper
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

Cite this document

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, no. 7, 2019, pp. 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 and 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, no. 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), pp. 525-531. doi: 10.1097/mph.0000000000001542

Federman N, Dragomir MD, Kizyma Z, Roganovic J, Bias P, Lammerich A, and 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 [cited 2024 October 08];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, no. 7, pp. 525-531, 2019. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:184:771828. [Accessed: 08 October 2024]

Please login to the repository to save this object to your list.
Metadata
Title (english)A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy
AuthorNoah Federman
AuthorMonica D. Dragomir
AuthorZoryana Kizyma
AuthorJelena Roganovic
AuthorPeter Bias
AuthorAndreas Lammerich
AuthorZipi R. Ben Arie
AuthorLinglong Zou
AuthorGerald Hoehn
AuthorAnton Buchner
Author's institutionUniversity of Rijeka
Faculty of Medicine
(Department of Pediatrics)
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Oncology
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Pediatrics
Abstract (english)
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.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review - international
Publication versionPublished version
Journal titleJournal of Pediatric Hematology/Oncology
Numberingvol. 41, no. 7, pp. 525-531
p-ISSN1077-4114
DOIhttps://doi.org/10.1097/mph.0000000000001542
URN:NBNurn:nbn:hr:184:771828
Publication2019
Document URLhttp://bib.irb.hr/1048377
Type of resourceText
Access conditionsClosed access
Terms of useLicence In copyright icon
Created on2022-02-09 11:35:34