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首页> 美国卫生研究院文献>International Journal of Molecular Sciences >Azacitidine for Front-Line Therapy of Patients with AML: Reproducible Efficacy Established by Direct Comparison of International Phase 3 Trial Data with Registry Data from the Austrian Azacitidine Registry of the AGMT Study Group
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Azacitidine for Front-Line Therapy of Patients with AML: Reproducible Efficacy Established by Direct Comparison of International Phase 3 Trial Data with Registry Data from the Austrian Azacitidine Registry of the AGMT Study Group

机译：阿扎胞苷用于AML患者的一线治疗：通过将国际3期试验数据与来自AGMT研究组的奥地利阿扎胞苷注册表的注册表数据进行直接比较建立了可再现的疗效

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摘要

We recently published a clinically-meaningful improvement in median overall survival (OS) for patients with acute myeloid leukaemia (AML), >30% bone marrow (BM) blasts and white blood cell (WBC) count ≤15 G/L, treated with front-line azacitidine versus conventional care regimens within a phase 3 clinical trial (AZA-AML-001; ; registered: February 2010). As results obtained in clinical trials are facing increased pressure to be confirmed by real-world data, we aimed to test whether data obtained in the AZA-AML-001 trial accurately represent observations made in routine clinical practice by analysing additional AML patients treated with azacitidine front-line within the Austrian Azacitidine Registry (AAR; ; registered: May 2012) and directly comparing patient-level data of both cohorts. We assessed the efficacy of front-line azacitidine in a total of 407 patients with newly-diagnosed AML. Firstly, we compared data from AML patients with WBC ≤ 15 G/L and >30% BM blasts included within the AZA-AML-001 trial treated with azacitidine (“AML-001” cohort; n = 214) with AAR patients meeting the same inclusion criteria (“AAR (001-like)” cohort; n = 95). The current analysis thus represents a new sub-analysis of the AML-001 trial, which is directly compared with a new sub-analysis of the AAR. Baseline characteristics, azacitidine application, response rates and OS were comparable between all patient cohorts within the trial or registry setting. Median OS was 9.9 versus 10.8 months (p = 0.616) for “AML-001” versus “AAR (001-like)” cohorts, respectively. Secondly, we pooled data from both cohorts (n = 309) and assessed the outcome. Median OS of the pooled cohorts was 10.3 (95% confidence interval: 8.7, 12.6) months, and the one-year survival rate was 45.8%. Thirdly, we compared data from AAR patients meeting AZA-AML-001 trial inclusion criteria (n = 95) versus all AAR patients with World Health Organization (WHO)-defined AML (“AAR (WHO-AML)” cohort; n = 193). Within the registry population, median OS for AAR patients meeting trial inclusion criteria versus all WHO-AML patients was 10.8 versus 11.8 months (p = 0.599), respectively. We thus tested and confirmed the efficacy of azacitidine as a front-line agent in patients with AML, >30% BM blasts and WBC ≤ 15 G/L in a routine clinical practice setting. We further show that the efficacy of azacitidine does not appear to be limited to AML patients who meet stringent clinical trial inclusion criteria, but instead appears efficacious as front-line treatment in all patients with WHO-AML.
机译：最近，我们发表了对急性髓细胞性白血病（AML），骨髓（BM）胚细胞和白细胞（WBC）计数≤15G / L≥30 G / L的患者的中位总生存期（OS）的临床意义重大改善，一线阿扎胞苷与传统护理方案的3期临床试验（AZA-AML-001 ；；注册日期：2010年2月）。由于临床试验中获得的结果面临着越来越大的压力，需要通过现实世界的数据来证实，我们旨在通过分析其他接受过阿扎胞苷治疗的AML患者，来测试AZA-AML-001试验中获得的数据是否准确代表了常规临床实践中的观察结果奥地利阿扎胞苷注册中心（AAR ；；注册：2012年5月）的第一线，直接比较两个队列的患者水平数据。我们评估了一线阿扎胞苷在总共407例新诊断的AML患者中的疗效。首先，我们比较了接受Azacitidine（“ AML-001”队列； n = 214）治疗的AZA-AML-001试验（包括AML-001组； n = 214）的WBC≤15 G / L且BM blast≥30％的AML患者的数据，以及符合条件的AAR患者的数据。相同的纳入标准（“ AAR（001-like）”队列； n = 95）。因此，当前分析代表了AML-001试验的新子分析，可直接与AAR的新子分析进行比较。在试验或注册表设置中，所有患者队列的基线特征，阿扎胞苷应用，缓解率和OS均相当。 “ AML-001”和“ AAR（001-like）”队列的中位OS分别为9.9和10.8个月（p = 0.616）。其次，我们汇总了两个队列的数据（n = 309）并评估了结果。合并队列的中位OS为10.3个月（95％置信区间：8.7、12.6）个月，一年生存率为45.8％。第三，我们比较了符合AZA-AML-001试验纳入标准的AAR患者（n = 95）与世界卫生组织（WHO）定义的AML（“ AAR（WHO-AML）”队列）的所有AAR患者的数据； n = 193 ）。在登记人群中，符合试验纳入标准的AAR患者与所有WHO-AML患者的OS中位数分别为10.8和11.8个月（p = 0.599）。因此，我们在常规临床实践中测试并证实了阿扎胞苷作为一线药物在AML，BM blast> 30％和WBC≤15 G / L的患者中的疗效。我们进一步表明，阿扎胞苷的疗效似乎并不限于符合严格临床试验纳入标准的AML患者，而是在所有WHO-AML患者中作为一线治疗有效。

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