Medizinische Klinik III, Hämatologie/Onkologie/Rheumatologie, Universitätsklinikum Bonn, Bonn, Germany.
Abteilung für Integrierte Onkologie, Universitätsklinikum Bonn, Bonn, Germany.
Eur J Haematol. 2020 Jun;104(6):538-545. doi: 10.1111/ejh.13395. Epub 2020 Mar 10.
Outcome for relapsed acute myeloid leukemia (AML) is poor. Cladribine has activity in AML, and an enhancing effect on other cytostatic drugs thus may help overcome resistance. Here, we present the final analysis of our phase II trial evaluating safety and efficacy of cladribine, cytarabine, and idarubicin (CAI) in relapsed AML.
Patients with relapsed AML after at least 6 months remission received two courses of CAI. After 9 patients, prolonged neutropenia prompted protocol change (omission of idarubicin in 2nd course and dose-reduction of cytarabine). Primary endpoints were remission rate and safety.
Twenty patients received treatment, fourteen one, and six two courses CAI/CA. After first course, complete remission (CR/CRi) was achieved in 60%. Most frequent toxicity was infection. Median OS was 8.8 months in all patients and 21.1 months in those with CR. Nine patients (48%) proceeded to allogeneic stem cell transplantation (allo-SCT), four of those are still alive and in CR, accounting for a 5-year survival rate of 55% of transplanted patients.
Cladribine, cytarabine, and idarubicin in relapsed AML is feasible and induces good response rates. As expected, infections are the most important complication. However, combined with allo-SCT, long-term survival can be achieved in a substantial number of patients.
复发性急性髓系白血病（AML）的预后较差。克拉屈滨在 AML 中有活性，并且对其他细胞抑制药物有增强作用，因此可能有助于克服耐药性。在此，我们报告了评估克拉屈滨、阿糖胞苷和伊达比星（CAI）在复发性 AML 中的安全性和疗效的 II 期试验的最终分析。
至少缓解 6 个月后复发的 AML 患者接受两个疗程的 CAI 治疗。在 9 例患者后，由于中性粒细胞减少症持续时间延长，促使方案改变（第 2 疗程中省略伊达比星和阿糖胞苷剂量减少）。主要终点是缓解率和安全性。
20 例患者接受了治疗，14 例接受了一个疗程 CAI/CA，6 例接受了两个疗程 CAI/CA。第一疗程后，完全缓解（CR/CRi）率达到 60%。最常见的毒性是感染。所有患者的中位总生存期（OS）为 8.8 个月，CR 患者的中位 OS 为 21.1 个月。9 例（48%）患者接受了异基因造血干细胞移植（allo-SCT），其中 4 例仍存活且处于 CR 状态，移植患者的 5 年生存率为 55%。
克拉屈滨、阿糖胞苷和伊达比星在复发性 AML 中是可行的，并能诱导良好的缓解率。正如预期的那样，感染是最重要的并发症。然而，与 allo-SCT 联合应用，可使大量患者获得长期生存。
