Granulocyte Colony-Stimulating Factor in the Treatment of High-Risk Febrile Neutropenia: a Multicenter Randomized Trial
Open Access
- 3 January 2001
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in JNCI Journal of the National Cancer Institute
- Vol. 93 (1), 31-38
- https://doi.org/10.1093/jnci/93.1.31
Abstract
Background: Granulocyte colony-stimulating factors (G-CSFs) have been shown to help prevent febrile neutropenia in certain subgroups of cancer patients undergoing chemotherapy, but their role in treating febrile neutropenia is controversial. The purpose of our study was to evaluate—in a prospective multicenter randomized clinical trial—the efficacy of adding G-CSF to broad-spectrum antibiotic treatment of patients with solid tumors and high-risk febrile neutropenia. Methods: A total of 210 patients with solid tumors treated with conventional-dose chemotherapy who presented with fever and grade IV neutropenia were considered to be eligible for the trial. They met at least one of the following high-risk criteria: profound neutropenia (absolute neutrophil count 3), short latency from previous chemotherapy cycle (P values were two-sided. Results: Patients randomly assigned to receive G-CSF had a significantly shorter duration of grade IV neutropenia (median, 2 days versus 3 days; P = .0004), antibiotic therapy (median, 5 days versus 6 days; P = .013), and hospital stay (median, 5 days versus 7 days; P = .015) than patients in the control arm. The incidence of serious medical complications not present at the initial clinical evaluation was 10% in the G-CSF group and 17% in the control group (P = .12), including five deaths in each study arm. The median cost of hospital stay and the median overall cost per patient admission were reduced by 17% (P = .01) and by 11% (P = .07), respectively, in the G-CSF arm compared with the control arm. Conclusions: Adding G-CSF to antibiotic therapy shortens the duration of neutropenia, reduces the duration of antibiotic therapy and hospitalization, and decreases hospital costs in patients with high-risk febrile neutropenia.Keywords
This publication has 20 references indexed in Scilit:
- Granulocyte colony-stimulating factor in established febrile neutropenia: a randomized study of pediatric patients.Journal of Clinical Oncology, 1997
- Randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating factor in patients with chemotherapy-related febrile neutropenia.Journal of Clinical Oncology, 1996
- Randomized comparison between antibiotics alone and antibiotics plus granulocyte-macrophage colony-stimulating factor (Escherichia coli-derived) in cancer patients with fever and neutropeniaAmerican Journal Of Medicine, 1996
- Improving Treatment of Chemotherapy-Induced Neutropenic Fever by Administration of Colony-Stimulating FactorsJNCI Journal of the National Cancer Institute, 1995
- American Society of Clinical Oncology. Recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines.Journal of Clinical Oncology, 1994
- Recombinant human granulocyte-macrophage colony-stimulating factor in the treatment of febrile neutropeniaThe Pediatric Infectious Disease Journal, 1994
- Reduction by Granulocyte Colony-Stimulating Factor of Fever and Neutropenia Induced by Chemotherapy in Patients with Small-Cell Lung CancerThe New England Journal of Medicine, 1991
- The colony stimulating factors discovery, development, and clinical applicationsCancer, 1990
- The Medical Course of Cancer Patients With Fever and NeutropeniaArchives of Internal Medicine, 1988
- Recombinant Human Granulocyte Colony-Stimulating Factor: Effects on Normal and Leukemic Myeloid CellsScience, 1986