Favorable effect of priming with granulocyte colony-stimulating factor in remission induction of acute myeloid leukemia restricted to dose escalation of cytarabine

Author:

Pabst Thomas1,Vellenga Edo2,van Putten Wim3,Schouten Harry C.4,Graux Carlos5,Vekemans Marie-Christiane6,Biemond Bart7,Sonneveld Peter8,Passweg Jakob9,Verdonck Leo10,Legdeur Marie-Cecile11,Theobald Matthias12,Jacky Emanuel13,Bargetzi Mario14,Maertens Johan15,Ossenkoppele Gert Jan16,Löwenberg Bob8

Affiliation:

1. University Hospital, Bern, Switzerland;

2. University Medical Center, Groningen, The Netherlands;

3. HOVON Data Center and Department of Trials and Statistics, Erasmus University Medical Center, Rotterdam, The Netherlands;

4. University Medical Center, Maastricht, The Netherlands;

5. Hôpital Mont Godinne, Yvoir, Belgium;

6. Hôpital St Luc, Bruxelles, Belgium;

7. Academic University Medical Center, Amsterdam, The Netherlands;

8. Erasmus University Medical Center, Rotterdam, The Netherlands;

9. University Hospital, Basel, Switzerland;

10. University Medical Center, Utrecht, The Netherlands;

11. Mesch Spectrum Twente, Enschede, The Netherlands;

12. Department of Internal Medicine III, University-Hospital, Mainz, Germany;

13. University Hospital, Zürich, Switzerland;

14. Kantonsspital, Aarau, Switzerland;

15. University Hospital Gasthuisberg, Leuven, Belgium; and

16. VU University Medical Center, Amsterdam, The Netherlands

Abstract

Abstract The clinical value of chemotherapy sensitization of acute myeloid leukemia (AML) with G-CSF priming has remained controversial. Cytarabine is a key constituent of remission induction chemotherapy. The effect of G-CSF priming has not been investigated in relationship with variable dose levels of cytarabine. We randomized 917 AML patients to receive G-CSF (456 patients) or no G-CSF (461 patients) at the days of chemotherapy. In the initial part of the study, 406 patients were also randomized between 2 cytarabine regimens comparing conventional-dose (199 patients) versus escalated-dose (207 patients) cytarabine in cycles 1 and 2. We found that patients after induction chemotherapy plus G-CSF had similar overall survival (43% vs 40%, P = .88), event-free survival (37% vs 31%, P = .29), and relapse rates (34% vs 36%, P = .77) at 5 years as those not receiving G-CSF. However, patients treated with the escalated-dose cytarabine regimen benefited from G-CSF priming, with improved event-free survival (P = .01) and overall survival (P = .003), compared with patients without G-CSF undergoing escalated-dose cytarabine treatment. A significant survival advantage of sensitizing AML for chemotherapy with G-CSF was not apparent in the entire study group, but it was seen in patients treated with escalated-dose cytarabine during remission induction. The HOVON-42 study is registered under The Netherlands Trial Registry (www.trialregister.nl) as #NTR230.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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