TY - JOUR T1 - Cladribine combined with high doses of arabinoside cytosine, mitoxantrone, and G-CSF (CLAG-M) is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia of the poor risk: a final report of the Polish Adult Leukemia Group. AU - Wierzbowska,Agnieszka, AU - Robak,Tadeusz, AU - Pluta,Agnieszka, AU - Wawrzyniak,Ewa, AU - Cebula,Barbara, AU - Hołowiecki,Jerzy, AU - Kyrcz-Krzemień,Sławomira, AU - Grosicki,Sebastian, AU - Giebel,Sebastian, AU - Skotnicki,Aleksander B, AU - Piatkowska-Jakubas,Beata, AU - Kuliczkowski,Kazimierz, AU - Kiełbiński,Marek, AU - Zawilska,Krystyna, AU - Kłoczko,Janusz, AU - Wrzesień-Kuś,Agata, AU - ,, Y1 - 2007/12/11/ PY - 2007/12/14/pubmed PY - 2008/2/6/medline PY - 2007/12/14/entrez SP - 115 EP - 26 JF - European journal of haematology JO - Eur J Haematol VL - 80 IS - 2 N2 - OBJECTIVES: Patients with primary refractory AML and with early relapses have unfavorable prognoses and require innovative therapeutic approaches. Purine analogs fludarabine (FA) and cladribine (2-CdA) increase cytotoxic effect of Ara-C in leukemic blasts and inhibit DNA repair mechanisms; therefore its association with Ara-C and mitoxantrone (MIT) results in a synergistic effect. In the current report, we present the final results of multi-center phase II study evaluating the efficacy and toxicity of CLAG-M salvage regimen in poor risk refractory/relapsed AML patients. METHODS: The induction chemotherapy consisted of 2-CdA 5 mg/m2, Ara-C 2 g/m2, MIT 10 mg/m2, and granulocyte-colony stimulating factor. In the case of PR, a second CLAG-M was administered. Patients in CR received consolidation courses based on high doses of Ara-C and MIT with or without 2-CdA. RESULTS: One hundred and eighteen patients from 11 centers were registered; 78 primary resistant and 40 relapsed. Sixty-six patients (58%) achieved CR after one or two courses of CLAG-M, 49 (35%) were refractory, and 8 (7%) died early. WBC >10 g/L and age >34 yr were factors associated with increased risk of treatment failure. Hematological toxicity was the most prominent toxicity of this regimen. The probability of OS at 4 yr was 14% (95% CI 4-23%). OS was influenced by age, WBC >10 g/L and poor karyotype in both univariate and multivariate analyses. The probability of 4 yr DFS was 30% for all 66 patients in CR (95% CI 11-49%). Poor karyotype was the only factor associated with decreased probability of DFS. CONCLUSIONS: We conclude that CLAG-M is a well-tolerated and highly effective salvage regimen in poor risk refractory/relapsed AML. SN - 1600-0609 UR - https://www.unboundmedicine.com/medline/citation/18076637/Cladribine_combined_with_high_doses_of_arabinoside_cytosine_mitoxantrone_and_G_CSF__CLAG_M__is_a_highly_effective_salvage_regimen_in_patients_with_refractory_and_relapsed_acute_myeloid_leukemia_of_the_poor_risk:_a_final_report_of_the_Polish_Adult_Leukemia_Group_ L2 - https://doi.org/10.1111/j.1600-0609.2007.00988.x DB - PRIME DP - Unbound Medicine ER -