1. ¹Department of Internal Medicine III, University Hospital of Ulm, Germany
2. ²Department of Hematology, Oncology and Clinical Immunology, University of Düsseldorf, Germany
3. ³Department of Internal Medicine I, University of Homburg, Germany
4. ⁴Department of Internal Medicine I, University of Bonn, Germany
5. ⁵Städtisches Klinikum, Karlsruhe, Germany
6. ⁶Städtisches Klinikum, Oldenburg, Germany
7. ⁷Department of Internal Medicine III, Technical University of Munich, Germany
8. ⁸Department of Internal Medicine IV, University of Giessen, Germany
9. ⁹Städtisches Krankenhaus München-Schwabing, Munich, Germany
10. ¹⁰Allgemeines Krankenhaus Altona, Hamburg, Germany
11. ¹¹Klinikum, Stuttgart, Germany
12. ¹²Department of Internal Medicine, University of Innsbruck, Austria
13. ¹³Department of Internal Medicine V, University of Heidelberg, Germany
14. ¹⁴Central Unit of Biostatistics, German Cancer Research Center Heidelberg, Germany

Correspondence: Dr RF Schlenk, Department of Internal Medicine III, University Hospital of Ulm, Robert-Koch-Strasse 8, 89081 Ulm, Germany. Fax: +49 731 50024405; E-mail: richard.schlenk@medizin.uni-ulm.de

Received 24 September 2004; Accepted 21 February 2005; Published online 21 April 2005.

Abstract

The objective of our study was to evaluate high-dose cytarabine in consolidation therapy in patients with newly diagnosed acute promyelocytic leukemia (APL). Patients (age 16–60 years) received induction therapy according to the AIDA protocol (all-trans retinoic acid, idarubicin) followed by one cycle of ICE (idarubicin, cytarabine, etoposide) and two cycles of HAM (cytarabine 3 g/m² q12h, days 1–3; mitoxantrone 10 mg/m², days 2 and 3). From 1995 to 2003, 82 patients were enrolled. In total, 72 patients (88%) achieved a complete remission, and 10 patients (12%) died from early/hypoplastic death (ED/HD). A total of 71 patients received at least one cycle of HAM. Relapse-free survival (RFS) and overall survival (OS) after 46 months were 83 and 82%, respectively. White blood cell count above 10.0 10⁹/l at diagnosis and additional chromosomal aberrations were unfavorable prognostic markers for OS, whereas no prognostic markers for RFS were identified including FLT3 mutations. In conclusion, high-dose cytarabine in consolidation therapy for patients with newly diagnosed APL is an effective treatment approach.