Safety assessment of intensive induction with vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) in the treatment of Ewing tumors in the EURO-E.W.I.N.G. 99 clinical trial

摘要: Background The EUROpean Ewing tumour Working Initiative of National Groups 1999 (EURO-E.W.I.N.G. 99) protocol prescribes six courses vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) as intensive induction chemotherapy for tumors (ET). Granulocyte-colony stimulating factor (G-CSF) is recommended. Adverse reactions (AR) were evaluated; quality assurance data collection reviewed. Procedure Safety from 4,746 VIDE in 851 patients less than 50 years with ET collected using a checklist evaluated descriptive statistics sub-groups including gender, age, tumor volume, analyzed by Wilcoxon Kruskal–Wallis tests. Results Myelosuppression infections the major AR but appropriate supportive therapy targeted dose intensity was maintained. Five VIDE-related deaths three due to sepsis reported. Renal cardiac toxicity reflected glomerular filtration rate (GFR)  males age-associated concerning hemoglobin, WBC, platelets, stomatitis, vomiting decreasing that is, children > adolescents > adults. No association volume found. In without G-CSF, neutropenia-related fever 60.8% 65.8%, infection 54.7% 61.0% courses, respectively, recorded. Conclusions AR under remained within expected range. Some AR, example, hematotoxicity significantly influenced age gender not volume. G-CSF did influence infection. Solicited safety checklists adequately reflects burden per course. Pediatr Blood Cancer © 2006 Wiley-Liss, Inc.