Intensive consolidation with G-CSF support: Tolerability, safety, reduced hospitalization, and efficacy in acute myeloid leukemia patients ≥60 years.

Abstract

The aim of this study was to evaluate the efficacy and feasibility of intensified consolidation therapy employing fludarabine and ARA-C in cycle 1 and intermediate-dose ARA-C (IDAC) in cycles 2 through 4, in elderly acute myeloid leukemia (AML) patients and to analyze the effects of pegfilgrastim on the duration of neutropenia, overall toxicity, and hospitalization-time during consolidation in these patients. Thirty nine elderly patients with de novo AML (median age 69.9 years) who achieved complete remission (CR) after induction-chemotherapy were analyzed. To examine the effect of pegfilgrastim on neutropenia and hospitalization, we compared cycles 2 and 4 where pegfilgrastim was given routinely from day 6 (IDAC-P) with cycle 3 where pegfilgrastim was only administered in case of severe infections and/or prolonged neutropenia. All four planned cycles were administered in 23/39 patients (59.0%); 5/39 patients (12.8%) received 3 cycles, 3/39 (7.7%) 2 cycles, and 8/39 (20.5%) one consolidation-cycle. The median duration of severe neutropenia was 7 days in cycle 2 (IDAC-P), 11.5 days in cycle 3 (IDAC), and 7.5 days in cycle 4 (IDAC-P) (P < .05). Median overall survival was 1.1 years and differed significantly between patients aged <75 and ≥75 years (P < .05). The probability to be alive after 5 years was 32%. Together, intensified consolidation can be administered in AML patients ≥60, and those who are <75 may benefit from this therapy. Routine administration of pegfilgrastim during consolidation shortens the time of neutropenia and hospitalization in these patients.

• Authors: Wolfgang R Sperr, Susanne Herndlhofer, Karoline Gleixner, Michael Girschikofsky, Ansgar Weltermann, Sigrid Machherndl-Spandl, Thamer Sliwa, Rainer Poehnl, Veronika Buxhofer-Ausch, Karin Strecker, Gregor Hoermann, Paul Knoebl, Ulrich Jaeger, Klaus Geissler, Michael Kundi, Peter Valent
• Journal: American journal of hematology (Am J Hematol) Vol. 92 Issue 10 Pg. E567-E574 (Oct 2017) ISSN: 1096-8652 [Electronic] United States
• PMID: 28699225 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)
• Copyright: © 2017 Wiley Periodicals, Inc.

Chemical References

• Recombinant Proteins
• Cytarabine
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Vidarabine
• fludarabine
• Filgrastim

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Consolidation Chemotherapy (adverse effects, methods)
• Cytarabine (administration & dosage, adverse effects, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Feasibility Studies
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects, therapeutic use)
• Hospitalization (statistics & numerical data)
• Humans
• Leukemia, Myeloid, Acute (drug therapy)
• Middle Aged
• Neutropenia (chemically induced, epidemiology)
• Polyethylene Glycols
• Prognosis
• Recombinant Proteins (administration & dosage, adverse effects, therapeutic use)
• Vidarabine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)