Combination of mitoxantrone and etoposide in the Treatment of Advanced Myelodysplastic Syndrome/Secondary Acute Myeloid Leukemia - a Multicenter Phase II Study

C. Baldus; L. Balleisen; W. Hirschmann; C. Rudolph; H. Bartels; N. Grobe; T. Zwingers; E. Thiel; W. U. Knauf

doi:10.1055/s-2002-26771

TumorDiagnostik & Therapie, Table of Contents

TumorDiagnostik & Therapie 2002; 23(2): 57-61
DOI: 10.1055/s-2002-26771

Originalarbeit/Original Article

Combination of mitoxantrone and etoposide in the Treatment of Advanced Myelodysplastic
Syndrome/Secondary Acute Myeloid Leukemia - a Multicenter Phase II Study

Kombinationschemotherapie mit Mitoxantron und Etoposid bei der Behandlung des fortgeschrittenen myelodysplastischen Syndroms/sekundärer akuter myeloischer Leukämie - eine multizentrische Phase II-StudieC. Baldus¹ , L. Balleisen² , W. Hirschmann³ , C. Rudolph⁴ , H. Bartels⁵ , N. Grobe⁶ , T. Zwingers⁷ , E. Thiel¹ , W. U. Knauf¹

¹Medizinische Klinik III, Universitätsklinikum Benjamin Franklin der Freien Universität Berlin
²Abt. Hämatologie und Onkologie, Evangelisches Krankenhaus, Hamm
³Abt. Hämatologie und Onkologie, Städtische Kliniken, Kassel
⁴Medizinische Klinik II, Karl-Thiem-Klinikum, Cottbus
⁵Abt. Hämatologie und Onkologie, Städtisches Krankenhaus Süd, Lübeck
⁶Medizinische Klinik I, Neubrandenburg
⁷estimate GmbH, Augsburg

Abstract

Background: The combination of mitoxantrone plus etoposide (NOVE) has been shown to be effective in the treatment of relapsed AML and AML in elderly patients. In order to further evaluate this regimen, we conducted a phase II study on NOVE in previously untreated patients diagnosed with sAML/advanced MDS (RAEBt). Patients: A total of 42 evaluable patients with a median age of 61 years (range 37 - 73) were analyzed. Median LDH was 315 U/l (range 67 - 1480) at time of diagnosis. Treatment was initiated within one month from diagnosis in 57 % of patients. NOVE consisted of mitoxantrone 10 mg/sqm d1 - 5 plus etoposide 100 mg/sqm d1 - 5. 15 patients received a second cycle NOVE. Results: Best response was CR in 15 patients (35 %), PR (eg. remaining features of MDS with blast cell count < 10 % in the bone marrow) in 6 patients (15 %), whereas 21 (50 %) patients were non-responders. Correlation with response was observed neither for FAB subtype nor for level of initial LDH. Overall, NOVE was well tolerated. However, three early deaths were reported. The median survival for all 42 patients was 175 days with an estimated overall survival of 20 % at 283 days. Conclusion: In summary, NOVE was demonstrated to be a palliative treatment option for patients with sAML/RAEBt showing a low toxicity profile and leading to an overall response rate of 50 %. Thus, it should be taken into consideration for treatment of this poor prognosis subtype of acute leukemia whenever allogeneic stem cell transplantation cannot be performed.

Key words

Secondary acute myeloid leukemia - Myelodysplastic syndrome - Mitoxantrone - Etoposide

Full Text

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Prof. Dr. W. Knauf

Medizinische Klinik III, Universitätsklinikum Benjamin Franklin der
Freien Universität Berlin

Hindenburgdamm 30

11220 Berlin

Germany

Phone: + 49-30-8445-4550

Fax: + 49-30-8445-4021

Email: knauf@ukbf.fu-berlin.de

Combination of mitoxantrone and etoposide in the Treatment of Advanced MyelodysplasticSyndrome/Secondary Acute Myeloid Leukemia - a Multicenter Phase II Study

Combination of mitoxantrone and etoposide in the Treatment of Advanced Myelodysplastic
Syndrome/Secondary Acute Myeloid Leukemia - a Multicenter Phase II Study