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

• Published in: American journal of hematology Vol. 92; no. 10; pp. E567 - E574
• Main Authors: Sperr, Wolfgang R, Herndlhofer, Susanne, Gleixner, Karoline, Girschikofsky, Michael, Weltermann, Ansgar, Machherndl-Spandl, Sigrid, Sliwa, Thamer, Poehnl, Rainer, Buxhofer-Ausch, Veronika, Strecker, Karin, Hoermann, Gregor, Knoebl, Paul, Jaeger, Ulrich, Geissler, Klaus, Kundi, Michael, Valent, Peter
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.10.2017
• Subjects: Acute myeloid leukemia; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemotherapy; Consolidation Chemotherapy - adverse effects; Consolidation Chemotherapy - methods; Cytarabine - administration & dosage; Cytarabine - adverse effects; Cytarabine - therapeutic use; Disease-Free Survival; Drug Administration Schedule; Feasibility Studies; Filgrastim; Fludarabine; Geriatrics; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Granulocyte Colony-Stimulating Factor - therapeutic use; Hospitalization; Hospitalization - statistics & numerical data; Humans; Leukemia; Leukemia, Myeloid, Acute - drug therapy; Middle Aged; Myeloid leukemia; Neutropenia; Neutropenia - chemically induced; Neutropenia - epidemiology; Polyethylene Glycols; Prognosis; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Remission; Toxicity; Vidarabine - administration & dosage; Vidarabine - adverse effects; Vidarabine - analogs & derivatives; Vidarabine - therapeutic use
• ISSN: 0361-8609; 1096-8652
• DOI: 10.1002/ajh.24847

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.