Hunault Mathilde, Pautas Cécile, Bertoli Sarah, Dumas Pierre-Yves, Raffoux Emmanuel, Hospital Marie-Anne, Marchand Tony, Heiblig Maël, Chantepie Sylvain, Carré Martin, Peterlin Pierre, Gallego-Hernanz Maria-Pilar, Lemasle Emilie, Guièze Romain, Simand Célestine, Turlure Pascal, Huynh Anne, Leguay Thibaut, Devillier Raynier, Quoc Stéphanie Nguyen, Duployez Nicolas, Luquet Isabelle, Penther Dominique, Celli-Lebras Karine, Mineur Ariane, Raus Nicole, Gardin Claude, Socié Gérard, Cahn Jean-Yves, Ifrah Norbert, Vey Norbert, de Latour Régis Peffault, Delabesse Eric, Preudhomme Claude, Hamel Jean-François, Pigneux Arnaud, Récher Christian, Dombret Hervé
Department of Hematology, Centre Hospitalier Universitaire (CHU) d'Angers, Centre de Recherche en Cancérologie et Immunologie Intégré de Nantes/Angers (CRCI2NA), Institut National de la Santé et de la Recherche Médical (INSERM) - Unit U1307, Centre National de la Recherche Scientifique (CNRS) - Unit UMR6075, Fédération Hospitalo-Universitaire Grand Ouest Against Leukemia (GOAL), Université d'Angers, Angers, France.
Department of Hematology, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Est Créteil, Créteil, France.
NEJM Evid. 2025 Jul;4(7):EVIDoa2400326. doi: 10.1056/EVIDoa2400326. Epub 2025 Jun 24.
We conducted a randomized controlled trial to compare intermediate doses (IDAC) with high doses of cytarabine (HDAC) as postinduction therapy in patients 18 to 60 years of age with newly diagnosed acute myeloid leukemia (AML). The main objectives were to evaluate noninferiority in overall survival (OS) after IDAC and safety.
Patients 18 to 60 years of age with newly diagnosed AML, except those with core-binding factor, acute promyelocytic, Philadelphia chromosome-positive, or post-myeloproliferative neoplasm AML, were eligible. After the induction course, we randomly assigned patients to either IDAC (1500 mg/m/12 hours) or HDAC (3000 mg/m/12 hours). Patients with intermediate- and adverse-risk AML were eligible for allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. The primary end point was OS in a predefined per-protocol analysis population. The primary analyses were performed in 1132 randomly assigned patients, with a noninferiority outcome adjusted on the European Leukemia Net (ELN) 2022 risk group, the use of induction anthracycline, the response to induction, and HSCT as a function of time following treatment.
At 5 years, OS was estimated at 59.3% (95% confidence interval [CI], 55.0 to 63.3) in the IDAC group versus 57.5% (95% CI, 53.3 to 61.5) in the HDAC group (adjusted hazard ratio, 0.96; 95% CI, 0.80 to 1.15; noninferiority test, P=0.0042). A preplanned analysis was unable to detect any interaction between IDAC or HDAC treatment effect and patient subgroups, including those defined by the ELN 2022 risk group or response to induction prior to random assignment. In addition, the severity of chemotherapy-induced myelosuppression and the incidence of related adverse events were lower after IDAC.
Our trial shows noninferior outcomes in patients 18 to 60 years of age with newly diagnosed AML treated with low- versus high-dose cytarabine; this occurred with similar or lower toxicities. (Funded by the Regional Clinical Research Office, Angers and others; EudraCT number, 2014-000699-24; ClinicalTrials.gov number, NCT02416388.).
我们进行了一项随机对照试验，比较中剂量阿糖胞苷（IDAC）与高剂量阿糖胞苷（HDAC）作为新诊断的18至60岁急性髓系白血病（AML）患者诱导缓解后的治疗方案。主要目标是评估IDAC治疗后的总生存期（OS）是否不劣于HDAC，以及安全性。
年龄在18至60岁之间、新诊断为AML的患者符合条件，但核心结合因子型、急性早幼粒细胞型、费城染色体阳性或骨髓增殖性肿瘤后AML患者除外。诱导疗程结束后，我们将患者随机分为IDAC组（1500mg/m²，每12小时一次）或HDAC组（3000mg/m²，每12小时一次）。中危和高危AML患者在首次缓解时 eligible for 异基因造血干细胞移植（HSCT）。主要终点是预定义的符合方案分析人群中的OS。主要分析在1132例随机分组的患者中进行，非劣效性结果根据欧洲白血病网（ELN）2022风险组、诱导期蒽环类药物的使用、诱导缓解反应以及HSCT（作为治疗后时间的函数）进行调整。
5年时，IDAC组的OS估计为59.3%（95%置信区间[CI]，55.0至63.3），HDAC组为57.5%（95%CI，53.3至61.5）（调整后的风险比为0.96；95%CI，0.80至1.15；非劣效性检验，P = 0.0042）。一项预先计划的分析未能检测到IDAC或HDAC治疗效果与患者亚组之间的任何相互作用，包括由ELN 2022风险组定义的亚组或随机分组前的诱导缓解反应。此外，IDAC治疗后化疗引起的骨髓抑制严重程度和相关不良事件的发生率较低。
我们的试验表明，新诊断的18至60岁AML患者接受低剂量与高剂量阿糖胞苷治疗的结果无劣效性；且毒性相似或更低。（由昂热地区临床研究办公室等资助；EudraCT编号，2014 - 000699 - 24；ClinicalTrials.gov编号，NCT02416388。）
“eligible for”直译为“有资格进行”，这里根据语境意译为“适合进行/符合条件进行”，使译文更通顺自然。你可根据实际需求调整。
