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

克拉屈滨 米托蒽醌 医学 内科学 氟达拉滨 阿糖胞苷 养生 中性粒细胞减少症 胃肠病学 毒性 肿瘤科 化疗 外科 耐火材料(行星科学) 挽救疗法 环磷酰胺 生物 天体生物学
作者
Agnieszka Wierzbowska,Tadeusz Robak,Agnieszka Pluta,Ewa Wawrzyniak,Barbara Cebula‐Obrzut,Jerzy Hołowiecki,Sławomira Kyrcz‐Krzemień,Sebastian Grosicki,Sebastian Giebel,Aleksander B. Skotnicki,Beata Piątkowska‐Jakubas,Kazimierz Kuliczkowski,Marek Kiełbiński,Krystyna Zawilska,Janusz Kłoczko,Agata Wrzesień‐Kuś
出处
期刊:European Journal of Haematology [Wiley]
卷期号:80 (2): 115-126 被引量:131
标识
DOI:10.1111/j.1600-0609.2007.00988.x
摘要

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.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.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.We conclude that CLAG-M is a well-tolerated and highly effective salvage regimen in poor risk refractory/relapsed AML.
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