The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Filgrastim in Remission Induction and Consolidation Therapy for Adults With De Novo Acute Myeloid Leukemia
Abstract
The safety and efficacy of filgrastim as an adjunct to acute myeloid leukemia (AML) induction and consolidation therapy was assessed in this prospective double-blind, randomized, placebo-controlled, multicenter trial. A total of 521 consecutive de novo AML patients aged 16 or more years were randomized to receive filgrastim (5 μg/kg/d subcutaneously) or placebo after standard induction as well as consolidation chemotherapy. Blinded study drug was given from 24 hours after chemotherapy until the absolute neutrophil count was ≥1.0 × 109/L for 3 consecutive days. The overall complete remission rate was 68%. After a median follow-up of 24 months (range 5 to 40) the median disease-free survival was 10 months (95% confidence interval [CI], 8.7 to 10.8) and the median overall survival was 13 months (95%CI, 12.2 to 14.6). These did not differ between treatment groups. Patients receiving filgrastim experienced neutrophil recovery 5 days earlier after induction 1 than those receiving placebo (P < .0001). This was accompanied by reductions in the duration of fever (7 v 8.5 days; P = .009), parenteral antibiotic use (15 v 18.5 days; P = .0001), and hospitalization (20 v 25 days; P = .0001). Similar reductions were seen after induction 2 and the consolidation courses. There was a significant reduction in the number of patients requiring systemic antifungal therapy in the filgrastim group during induction treatment (34% v 43%; P = .04). In conclusion, filgrastim is safe in that it had no negative impact on the prognosis of the AML patients. In addition, it effectively reduced the duration of neutropenia, leading to significant clinical benefits by reducing the duration of fever; requirement for parenteral anti-infectives, specifically amphotericin B; and the duration of hospitalization.
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Filgrastim improves survival in lethally irradiated nonhuman primates
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Metadata
- Authors
- Heil, G., Hoelzer, D., Sanz, M. A., Lechner, K., Liu Yin, J. A., Papa, G., Noens, L., Szer, J., Ganser, A., O'Brien, C., Matcham, J., & Barge, A.
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 1997-12-15
- Volume
- 90
- Issue
- 12
- Pages
- 4710-4718
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W1608878503
- Cited by
- 332
- References
- 30
- FWCI
- 9.44
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Filgrastim in Remission Induction and Consolidation Therapy for Adults With De Novo Acute Myeloid Leukemia. https://app.cochat.ai/papers/10.1182/blood.v90.12.4710
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- Heil, G., Hoelzer, D., Sanz, M. A., Lechner, K., Liu Yin, J. A., Papa, G., Noens, L., Szer, J., Ganser, A., O'Brien, C., Matcham, J., & Barge, A. (1997). A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Filgrastim in Remission Induction and Consolidation Therapy for Adults With De Novo Acute Myeloid Leukemia. Blood. https://doi.org/10.1182/blood.v90.12.4710
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
