A randomized phase-III study of the efficacy of granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia. Berlin-Frankfurt-Münster Study Group.

作者: K Welte , A Reiter , K Mempel , M Pfetsch , G Schwab

DOI: 10.1182/BLOOD.V87.8.3143.BLOODJOURNAL8783143

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摘要: Overall chemotherapeutic treatment results in pediatric acute lymphoblastic leukemia (ALL) are good, with event-free survival (EFS) rates over 70%. However, for a subset of patients characterized by high- risk (HR) features the outcome is less favorable, EFS below 50%. Intensification chemotherapy may improve those patients, but increased toxicity, particularly myelosuppression, limits escalation dose intensity. Recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF) known to reduce myelosuppression after cancer adults. The objective this study was examine effect r-metHuG-CSF on HR ALL and overall response rate chemotherapy. Patients were randomized receive nine alternating cycles according German ALL-Berlin-Frankfurt-Munster 90 protocol either alone or followed administered prophylactically at 5 microg/kg/d subcutaneously. In both groups, planned interval between courses minimum 21 days. We report here interim 34 patients. incidence febrile neutropenia (absolute neutrophil count = 38.5 degrees C) 17% children receiving r-metHuG-CSF, as compared 40% control group (P .007). addition, median total duration reduced from 20.3 6.2 days per patient .02). Culture-confirmed infections occurred frequently (8% v 15%; P .04), intravenous antibiotic use significantly 32.2 18.2 A tighter adherence schedule also facilitated With follow-up 3.3 years, estimated 4 years 41% +/- 12%. conclusion, neutropenia, culture-confirmed infections, administration allowed schedule.

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