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Safety assessment of intensive induction with vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) in the treatment of Ewing tumors in the EURO-EWING 99 clinical trial

Lookup NU author(s): Emeritus Professor Alan Craft

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Abstract

Background: The EUROpean Ewing tumour Working Initiative of National Groups 1999 (EURO-E.W.I.N.G. 99) protocol prescribes six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) as intensive induction chemotherapy for Ewing tumors (ET). Granulocyte-colony stimulating factor (G-CSF) is recommended. Adverse reactions (AR) were evaluated; quality assurance of data collection reviewed. Procedure: Safety data from 4,746 courses of VIDE in 851 patients less than 50 years with ET were collected using a checklist and evaluated using descriptive statistics with sub-groups including gender, age, and tumor volume, analyzed by Wilcoxon and Kruskal-Wallis tests. Results: Myelosuppression and infections were the major AR but with appropriate supportive therapy targeted dose intensity was maintained. Five VIDE-related deaths with three due to sepsis were reported. Renal and cardiac toxicity were reflected by glomerular filtration rate (GFR) < 39 ml/min/1.73m(2) in 0.1%, tubular phosphate reabsorption <= 0.80 in 1.9%, and left ventricular shortening fracture < 28% in 2.5% VIDE courses. Statistically significant gender-associated AR concerning hemoglobin and platelets were observed with females > males as were age-associated AR concerning hemoglobin, WBC, platelets, stomatitis, and vomiting with AR decreasing with age, that is, children > adolescents > adults. No association of AR to tumor volume was found. In VIDE courses with and without G-CSF, neutropenia-related fever in 60.8% and 65.8%, and infection in 54.7% and 61.0% courses, respectively, were recorded. Conclusions: AR under VIDE remained within the expected range. Some AR, for example, hematotoxicity were significantly influenced by age and gender but not by tumor volume. G-CSF did not significantly influence neutropenia-related fever and infection. Solicited safety collection with checklists adequately reflects the burden per course.

Publication metadata

Author(s): Juergens, C., Weston, C., Lewis, I., Whelan, J., Paulussen, M., Oberlin, O., Michon, J., Zoubek, A., Juergens, H., Craft, A. W.

Publication type: Article

Publication status: Published

Journal: Paediatric Blood and Cancer

Year: 2006

Volume: 47

Issue: 1

Pages: 22-29

ISSN (print): 1545-5009

ISSN (electronic): 1545-5017

URL: http://dx.doi.org/10.1002/pbc.20820

DOI: 10.1002/pbc.20820

PubMed id: 16572419

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