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Combined Use of Erythropoietin and Granulocyte Colony-Stimulating Factor Does Not Decrease Blood Transfusion Requirements During Induction Therapy for High-Risk Neuroblastoma: A Randomized Controlled Trial

From the Departments of Hematology-Oncology, Biostatistics, and Surgery, St Jude Children's Research Hospital; College of Medicine, University of Tennessee Health Science Center, Memphis, TN; and Division of Hematology/Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Address reprint requests to Victor M. Santana, MD, Department of Hematology-Oncology, Mail Stop 260, St Jude Children's Research Hospital, 332 N Lauderdale St, Memphis, TN 38105-2794; e-mail: Victor.Santana{at}stjude.org

PURPOSE: To evaluate the efficacy of recombinant erythropoietin (EPO) and granulocyte colony-stimulating factor (G-CSF) in reducing blood transfusion requirements and stimulating hematopoiesis in children with high-risk neuroblastoma.

PATIENTS AND METHODS: Thirty-eight patients given six cycles of intensive induction chemotherapy for high-risk neuroblastoma were randomized to receive G-CSF (n = 20) or G-CSF + EPO (n = 18). Cytokines were given subcutaneously each day, starting 24 hours after each chemotherapy cycle and continuing until 48 hours before the start of the next cycle. The primary end point was the effect of EPO on total red cell transfusion requirements during induction therapy.

RESULTS: Patients who received G-CSF + EPO had a higher red cell transfusion requirement (median, 161.0 mL/kg) than did those who received G-CSF alone (median, 106.6 mL/kg; P = .005). In addition, among patients given transfusions for hemoglobin 8 g/dL, those in the G-CSF + EPO group received more red cell transfusions than did those given G-CSF alone (median per patient, 10 v 8, respectively; P = .044). The two treatment groups had similar cumulative durations of neutropenia, incidences of febrile neutropenia, platelet transfusion requirements, and numbers of platelet transfusions; they also received induction chemotherapy for similar durations and had similar probabilities of progression-free survival and overall survival.

CONCLUSION: The addition of EPO to the G-CSF regimen provides no benefit for patients receiving intensive induction chemotherapy for high-risk neuroblastoma.

Supported in part by United States Public Health Service Cancer Center Support (CORE) Grant CA-21765; Childhood Solid Tumor Program Project Grant CA-23099; Amgen Inc; and the American Lebanese Syrian Associated Charities.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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