1. ¹Department of Hematology, Klinikum Grosshadern, Ludwig-Maximilians University, Munich, Germany
2. ²EORTC Data Center, Brussels, Belgium
3. ³Department of Hematology, Hopital Edouard Herriot, Lyon, France
4. ⁴Department of Hematology, Hopital Necker, Paris, France
5. ⁵Department of Hematology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
6. ⁶Department of Hematology, Universitair Ziekenhuis Antwerpen, Edegem, Belgium
7. ⁷Department of Hematology, Hotel-Dieu, Paris, France
8. ⁸Department of Hematology, Ospedale Oncologico A Businco, Cagliari, Italy
9. ⁹Department of Hemato-Oncology, Centre Hospitalier Universitaire Sart-Tilman, Liège, Belgium
10. ¹⁰Department of Hematology, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy
11. ¹¹Department of Hematology, Ospedale San Carlo, Potenza, Italy
12. ¹²Department of Hematology, Universita Del Sacro Cuore, Policlinico A Gemelli, Roma, Italy
13. ¹³Department of Hematology, University degli Study Di Parma, Parma, Italy
14. ¹⁴Department of Hematology, Ospedale Di Montefiascone, Montefiascone, Italy
15. ¹⁵GIMEMA Data Center, Universita Degli Studi La Sapienza, Roma, Italy
16. ¹⁶Fondazione GIMEMA, Universita Degli Studi La Sapienza, Roma, Italy
17. ¹⁷Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands
18. ¹⁸Department of Hematology, Ospedale San Eugenio, Roma, Italy

Correspondence: Dr S Suciu, EORTC Data Center, Biostatistical department, Av. E Mounier 83/11, B-1200 Brussels, Belgium. E-mail: stefan.suciu@eortc.be

Received 21 April 2006; Revised 3 July 2006; Accepted 5 July 2006; Published online 17 August 2006.

Abstract

In this trial, acute myeloid leukemia patients (pts) aged 61–80 years received MICE (mitoxantrone, etoposide and cytarabine) induction chemotherapy in combination with different schedules of granulocyte colony-stimulating factor administration. Pts in complete remission were subsequently randomized for two cycles of consolidation therapy: mini-ICE regimen (idarubicin, etoposide and cytarabine) given according to either an intravenous (i.v.) or a 'non-infusional' schedule. Among the 346 pts randomized for the second step, 331 pts received consolidation-1 and 182 consolidation-2. A total of 290 events (255 relapses, 35 deaths in first CR) have been reported. The median follow-up was 4.4 years. No significant differences were detected in terms of disease-free survival (median 9 vs 10.4 months, P=0.15, hazard ratio (HR) =1.18, 95% confidence interval (CI) 0.94–1.49) – primary end point – and survival (median 15.7 vs 17.8 months, P=0.19, HR=1.17, 95% CI 0.92–1.50). In the 'non-infusional' arm grade 3–4 vomiting (10 vs 2%; P=0.001) and diarrhea (10 vs 4%; P=0.03) were higher than in the 'i.v.' arm, whereas time to platelet recovery >20 10⁹/l (median: 19 vs 23 days; P=0.02) and duration of hospitalization (mean: 15 vs 27 days; P<0.0001) was shorter. The 'non-infusional' consolidation regimen resulted in an antileukemic effect similar to the intravenous regimen, which was less myelosuppressive and associated with less hospitalization days.