Hematology Clinic, Department of Internal Medicine (DiMI), University of Genoa, IRCCS AOU S. Martino-IST, Genoa, Italy.
Second Division of Hematology and Bone Marrow Transplantation, IRCCS AOU S. Martino-IST, Genoa, Italy.
Am J Hematol. 2016 Aug;91(8):755-62. doi: 10.1002/ajh.24391. Epub 2016 Jun 15.
About 105 consecutive acute myeloid leukemia (AML) patients treated with the same induction-consolidation program between 2004 and 2013 were retrospectively analyzed. Median age was 47 years. The first induction course included fludarabine (Flu) and high-dose cytarabine (Ara-C) plus idarubicin (Ida), with or without gemtuzumab-ozogamicin (GO) 3 mg/m(2) (FLAI-5). Patients achieving complete remission (CR) received a second course without fludarabine but with higher dose of idarubicin. Patients not achieving CR received an intensified second course. Patients not scheduled for early allogeneic bone marrow transplantation (HSCT) where planned to receive at least two courses of consolidation therapy with Ara-C. Our double induction strategy significantly differs from described fludarabine-containing regimens, as patients achieving CR receive a second course without fludarabine, to avoid excess toxicity, and Ara-C consolidation is administrated at the reduced cumulative dose of 8 g/m(2) per cycle. Toxicity is a major concern in fludarabine containing induction, including the recent Medical Research Council AML15 fludarabine, cytarabine, idaraubicin and G-CSF (FLAG-Ida) arm, and, despite higher anti-leukemic efficacy, only a minority of patients is able to complete the full planned program. In this article, we show that our therapeutic program is generally well tolerated, as most patients were able to receive subsequent therapy at full dose and in a timely manner, with a 30-day mortality of 4.8%. The omission of fludarabine in the second course did not reduce efficacy, as a CR rate of 83% was achieved and 3-year disease-free survival and overall survival (OS) were 49.6% and 50.9%, respectively. Our experience shows that FLAI-5/Ara-C + Ida double induction followed by risk-oriented consolidation therapy can result in good overall outcome with acceptable toxicity. Am. J. Hematol. 91:755-762, 2016. © 2016 Wiley Periodicals, Inc.
对 2004 年至 2013 年间采用相同诱导-巩固方案治疗的 105 例连续急性髓系白血病(AML)患者进行回顾性分析。中位年龄为 47 岁。第一诱导疗程包括氟达拉滨(Flu)和高剂量阿糖胞苷(Ara-C)加伊达比星(Ida),可加或不加吉妥珠单抗奥佐米星(GO)3mg/m²(FLAI-5)。达到完全缓解(CR)的患者接受无氟达拉滨但伊达比星剂量更高的第二疗程。未达到 CR 的患者接受强化第二疗程。未计划进行早期异基因骨髓移植(HSCT)的患者计划接受至少两个周期的 Ara-C 巩固治疗。我们的双诱导策略与描述的含氟达拉滨方案明显不同,因为达到 CR 的患者接受无氟达拉滨的第二疗程,以避免过度毒性,并且 Ara-C 巩固治疗以每个周期 8g/m²的累积剂量减少。在含氟达拉滨的诱导治疗中,毒性是一个主要关注点,包括最近的医学研究委员会 AML15 氟达拉滨、阿糖胞苷、伊达比星和 G-CSF(FLAG-Ida)臂,尽管抗白血病疗效较高,但只有少数患者能够完成完整的计划方案。在本文中,我们表明我们的治疗方案通常具有良好的耐受性,因为大多数患者能够按时以全剂量接受后续治疗,30 天死亡率为 4.8%。在第二疗程中省略氟达拉滨并未降低疗效,因为达到了 83%的 CR 率,3 年无病生存和总生存(OS)分别为 49.6%和 50.9%。我们的经验表明,FLAI-5/Ara-C+Ida 双诱导后进行风险导向的巩固治疗可获得良好的总体结果,且毒性可接受。Am. J. Hematol. 91:755-762, 2016. © 2016 Wiley Periodicals, Inc.