A multicenter, open, noncomparative, phase II study of the combination of cladribine (2-chlorodeoxyadenosine), cytarabine, granulocyte colony-stimulating factor and mitoxantrone as induction therapy in refractory acute myeloid leukemia: a report of the Polish Adult Leukemia Group
| Autor: | Tadeusz Robak, Andrzej Pluta, Anna Krawczynska, Slawomira Kyrcz-Krzemien, Malgorzata Wach, Agnieszka Wierzbowska, Sebastian Grosicki, Ewa Lech-Marańda, Wojciech Baran, Ewa Wawrzyniak, Andrzej Hellmann, Grzegorz Mazur, Jerzy Holowiecki, Anna Dmoszynska, M. Kiebiński, Agata Wrzesień-Kuś, Kazimierz Kuliczkowski |
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| Rok vydání: | 2005 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Pharmacology Internal medicine Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Chlorodeoxyadenosine Humans Cladribine Aged Salvage Therapy Mitoxantrone business.industry Remission Induction Cytarabine Hematopoietic Stem Cell Transplantation Myeloid leukemia Hematology General Medicine Middle Aged medicine.disease Hematologic Diseases Survival Analysis Fludarabine Leukemia Regimen Leukemia Myeloid Acute Disease Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Annals of hematology. 84(9) |
| ISSN: | 0939-5555 |
| Popis: | Purine nucleoside analogues, cladribine (2-chlorodeoxyadenosine, 2-CdA) and fludarabine (FAMP) are active agents in acute myeloid leukemias (AMLs). Synergistic interaction between FAMP or 2-CdA with cytarabine (cytosine arabinoside, Ara-C) has been demonstrated in preclinical and clinical studies. The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of induction treatment consisting of 2-CdA (5 mg/m2), Ara-C (2 g/m2), mitoxantrone (MIT, 10 mg/m2) and granulocyte colony-stimulating factor (G-CSF) (CLAG-M) in refractory AML. In case of partial remission, a second CLAG-M was administered. Patients in complete remission (CR) received consolidation courses based on high-dose Ara-C and MIT with or without 2-CdA. Forty-three patients from five centers were registered: 25 primary resistant and 18 relapsed. CR was achieved in 21 (49%) patients, 20 (47%) were refractory and 2 (5%) died early. Hematologic toxicity was the most prominent toxicity of this regimen. The overall survival (OS; 1 year) for the 42 patients as a whole and the 20 patients in CR were 43% and 73%, respectively. Disease-free survival (1 year) was 68.6%. None of the analyzed prognostic factors influenced the CR and OS probability significantly. We conclude that CLAG-M regimen has significant antileukemia activity in refractory AML, which seems to be better than the activity of many other regimens. The toxicity of the treatment is acceptable. |
| Databáze: | OpenAIRE |
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