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Granulocyte Colony-Stimulating Factor in Induction Treatment of Children With Non-Hodgkin’s Lymphoma: A Randomized Study of the French Society of Pediatric Oncology

From the Departments of Pediatrics and Statistics, Institut Gustave Roussy, Villejuif; Onco-Hematology Pediatrics Department, Hôpital Purpan, Centre Hospitalier Universitaire, Toulouse; Pediatric Hematology Department, Hôpital St-Louis, and Pediatrics Department, Institut Curie, Paris; Pediatrics Department, Centre Léon Bérard, Lyon; Onco-Hematology Pediatrics Department, Hôpital Brabois, Centre Hospitalier Universitaire, Nancy; Onco-Hematology Pediatrics Department, Centre Hospitalier Universitaire, Nantes; Onco-Hematology Pediatrics Department, Centre Hospitalier Universitaire, Lille; and Onco-Hematology Pediatrics Department, Centre Hospitalier Universitaire, Caen, France.

Address reprint requests to Catherine Patte, MD, Pediatrics Department, Institut Gustave Roussy, Rue Camille Desmoulins, 94805 Villejuif Cedex, France; email: patte{at}.igr.fr

PURPOSE: To determine whether granulocyte colony-stimulating factor (G-CSF; lenograstim) decreases the incidence of febrile neutropenia after induction courses in treatment of childhood non-Hodgkin’s lymphoma (NHL).

PATIENTS AND METHODS: Patients were randomized to receive (G-CSF+) or not receive (G-CSF-) prophylactic G-CSF, 5 µg/kg/d, from day 7 until an absolute neutrophil count 500/µL was sustained over 48 hours, after two consecutive induction courses of cyclophosphamide 1.5 or 3 g/m², vincristine 2 mg/m², prednisone 60 mg/m²/d x 5, doxorubicin 60 mg/m², high-dose methotrexate 3 or 8 g/m², and intrathecal injections (COPAD[M]) on protocols LMB89, LMT89, and HM91 of the French Society of Pediatric Oncology.

RESULTS: One hundred forty-eight patients were assessable, 75 G-CSF+ and 73 G-CSF-. Although duration of neutropenia less than 500/µL was 3 days shorter in G-CSF+ patients (P = 10^-4), incidence of febrile neutropenia (89% v 93% in the first course, 88% v 88% in the second course), durations of hospitalization and antimicrobial therapy, percentages of infections, mucositis, and transfusions were not significantly different. Although the percentage of G-CSF+ patients commencing the following course on day 21 was significantly higher (84% v 68% after the first and 57% v 38% after the second course; P < .05), the median delay between the two courses was only 1 day less in G-CSF+ patients (median delay after first COPAD(M), 19 v 20 days, P = .01; after second, 21 v 22 days, P = not significant). Remission and survival rates were similar in both arms.

CONCLUSION: This study demonstrates that G-CSF did not decrease treatment-related morbidity, nor increase the dose-intensity in children undergoing COPAD(M) induction chemotherapy for NHL.

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