Capelli Debora, Chiarucci Martina, Poloni Antonella, Saraceni Francesco, Mancini Giorgia, Trappolini Silvia, Troiani Emanuela, Montanari Mauro, Scortechini Ilaria, Offidani Massimo, Rupoli Serena, Scortechini Anna Rita, Gini Guido, Discepoli Giancarlo, Leoni Pietro, Olivieri Attilio
Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Torrette di Ancona, Italy.
Hematology Department, Ospedale Mazzoni, Ascoli Piceno, Italy.
Biol Blood Marrow Transplant. 2014 Sep;20(9):1399-406. doi: 10.1016/j.bbmt.2014.05.019. Epub 2014 May 28.
We prospectively evaluated 2 postconsolidation strategies, administered according to the mobilization outcome, in 72 acute myeloid leukemia (AML) fit elderly patients, achieving complete remission after the first high-dose cytarabine-based induction. Autologous stem cell transplantation (ASCT) was performed in patients collecting ≥3 × 10(6) CD34(+)/kg and low-dose gemtuzumab ozogamicin (GO) was performed in poor mobilizers (collecting <3 × 10(6) CD34(+)/kg). Fifty-five patients (76.3%) underwent peripheral blood stem cell (PBSC) mobilization, after first consolidation, and 24 of 55 (44%) collected >3 × 10(6) CD34(+) cells/kg. Among the 55 patients eligible for PBSC mobilization, 7 did not receive the planned treatment, 23 were allocated for ASCT, and 25 were allocated for GO on an intention-to-treat basis. With a median follow-up of 70 months (range, 24 to 124), 20 of 55 patients are alive, 18 of them in continuous complete remission. The 8-year overall survival (OS) and disease-free survival (DFS) are, respectively, 35.9% (95% confidence interval [CI] 24% to 49.8%) and 31.2% (95% CI, 21% to 43.8%), median OS and DFS were 22 and 16 months, respectively. In multivariate analysis, postconsolidation treatment and hyperleukocytosis (WBC > 50,000/μL) significantly predicted OS and DFS, whereas secondary AML was significantly associated with a higher relapse rate (83.4% versus 54% of de novo AML). Patients with hyperleukocytosis had 0% 3-year OS versus the 46% (at 8 years) in patients without hyperleukocytosis (P = .01); 57% of patients in the GO arm are alive at 8 years, compared with 25.4% of patients in the ASCT arm, who had an overall relative risk (RR) of death of 2.6 (95% CI, 1.2 to 5.8; P = .02). DFS at 8 years was 45.3% in patients receiving GO, compared with 26% in ASCT arm (RR, 2.1; 95% CI, 1 to 4.3; P = .05). Our study outlines low feasibility and efficacy of ASCT in elderly AML patients, whereas postconsolidation with GO appears safe and effective in this unfavorable setting. The study was registered at Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.
我们前瞻性评估了2种巩固治疗后的策略，根据动员结果对72例年龄较大且身体状况适合的急性髓系白血病（AML）患者进行治疗，这些患者在首次基于大剂量阿糖胞苷的诱导治疗后实现了完全缓解。对于采集到≥3×10(6) CD34(+)/kg的患者进行自体干细胞移植（ASCT），对于动员效果不佳（采集到<3×10(6) CD34(+)/kg）的患者给予低剂量吉妥珠单抗奥唑米星（GO）治疗。55例患者（76.3%）在首次巩固治疗后接受了外周血干细胞（PBSC）动员，其中24例（44%）采集到>3×10(6) CD34(+)细胞/kg。在55例符合PBSC动员条件的患者中，7例未接受计划治疗，23例被分配接受ASCT，25例按意向性治疗原则被分配接受GO治疗。中位随访70个月（范围24至124个月），55例患者中有20例存活，其中18例持续完全缓解。8年总生存率（OS）和无病生存率（DFS）分别为35.9%（95%置信区间[CI] 24%至49.8%）和31.2%（95% CI，21%至43.8%），中位OS和DFS分别为22个月和16个月。多因素分析显示，巩固治疗后方案和高白细胞血症（白细胞计数>50,000/μL）显著预测OS和DFS，而继发性AML与较高的复发率显著相关（83.4%对比初发AML的54%）。高白细胞血症患者的3年OS为0%，而无高白细胞血症患者的3年OS为46%（8年时）（P = 0.01）；GO组8年时57%的患者存活，ASCT组为25.4%，ASCT组的总体死亡相对风险（RR）为2.6（95% CI，1.2至5.8；P = 0.02）。接受GO治疗患者的8年DFS为45.3%，ASCT组为26%（RR，2.1；95% CI，1至4.3；P = 0.05）。我们的研究概述了ASCT在老年AML患者中的低可行性和疗效，而在这种不利情况下，GO巩固治疗似乎安全有效。该研究已在日本大学医学情报网临床试验注册中心（www.umin.ac.jp/ctr）注册，注册号为R000014052。
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