Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study.

Details

Serval ID
serval:BIB_C433D50F28E0
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study.
Journal
Journal of Clinical Oncology
Author(s)
Ladenstein R., Valteau-Couanet D., Brock P., Yaniv I., Castel V., Laureys G., Malis J., Papadakis V., Lacerda A., Ruud E., Kogner P., Garami M., Balwierz W., Schroeder H., Beck-Popovic M., Schreier G., Machin D., Pötschger U., Pearson A.
ISSN
1527-7755[electronic], 0732-183X[linking]
Publication state
Published
Issued date
2010
Volume
28
Number
21
Pages
3516-3524
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Purpose To reduce the incidence of febrile neutropenia during rapid COJEC (cisplatin, vincristine, carboplatin, etoposide, and cyclophosphamide given in a rapid delivery schedule) induction. In the High-Risk Neuroblastoma-1 (HR-NBL1) trial, the International Society of Paediatric Oncology European Neuroblastoma Group (SIOPEN) randomly assigned patients to primary prophylactic (PP) versus symptom-triggered granulocyte colony-stimulating factor (GCSF; filgrastim).
Patients and Methods From May 2002 to November 2005, 239 patients in 16 countries were randomly assigned to receive or not receive PPGCSF. There were 144 boys with a median age of 3.1 years (range, 1 to 17 years) of whom 217 had International Neuroblastoma Staging System (INSS) stage 4 and 22 had stage 2 or 3 MYCN-amplified disease. The prophylactic arm received a single daily dose of 5 μg/kg GCSF, starting after each of the eight COJEC chemotherapy cycles and stopping 24 hours before the next cycle. Chemotherapy was administered every 10 days regardless of hematologic recovery, provided that infection was controlled.
Results The PPGCSF arm had significantly fewer febrile neutropenic episodes (P = .002), days with fever (P = .004), hospital days (P = .017), and antibiotic days (P = .001). Reported Common Toxicity Criteria (CTC) graded toxicity was also significantly reduced: infections per cycle (P = .002), fever (P < .001), severe leucopenia (P < .001), neutropenia (P < .001), mucositis (P = .002), nausea/vomiting (P = .045), and constipation (P = .008). Severe weight loss was reduced significantly by 50% (P = .013). Protocol compliance with the rapid induction schedule was also significantly better in the PPGCSF arm shown by shorter time to completion (P = .005). PPGCSF did not adversely affect response rates or success of peripheral-blood stem-cell harvest.
Following these results, PPG-GSF was advised for all patients on rapid COJEC induction.
Keywords
Adolescent, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Child, Child, Preschool, Female, Granulocyte Colony-Stimulating Factor/adverse effects, Granulocyte Colony-Stimulating Factor/therapeutic use, Humans, Infant, Male, Neuroblastoma/drug therapy, Neuroblastoma/psychology, Quality of Life, Risk
Pubmed
Web of science
Create date
17/02/2011 10:32
Last modification date
20/08/2019 15:39
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