Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.
Netwerk Antwerpen, Antwerp, Belgium.
Leukemia. 2020 Jul;34(7):1751-1759. doi: 10.1038/s41375-020-0725-0. Epub 2020 Feb 4.
More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy ("3 + 7") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).
在老年急性髓系白血病（AML）患者中，迫切需要更有效的治疗方法。我们假设在强化标准化疗中加入来那度胺可能会改善他们的预后。在确定来那度胺对老年 AML 患者安全后，我们在此随机 2 期研究（n = 222）中，将患者随机分配接受标准化疗（“3 + 7”）联合或不联合来那度胺（20 mg/天，第 1-21 天）。在第二个周期中，患者接受阿糖胞苷 1000 mg/m2，每日两次，第 1-6 天，联合或不联合来那度胺（20 mg/天，第 1-21 天）。两组的完全缓解/完全缓解伴血细胞不完全恢复（CR/CRi）率没有差异（69% vs. 66%）。标准组和来那度胺组的无事件生存（EFS）在 36 个月时分别为 19%和 21%，总生存（OS）分别为 35%和 30%。治疗组之间不良事件的频率和严重程度没有显著差异。心血管毒性罕见，两组分布均匀。本研究结果表明，来那度胺联合标准缓解诱导化疗不能改善老年 AML 患者的治疗结果。该试验在荷兰临床试验注册库（www.trialregister.nl）注册，编号为 NTR2294。
