Advanced-stage large-cell lymphoma in children and adolescents: Results of a randomized trial incorporating intermediate-dose methotrexate and high-dose cytarabine in the maintenance phase of the APO regimen: A Pediatric Oncology Group phase III trial
Advanced-stage large-cell lymphoma in children and adolescents: Results of a randomized trial incorporating intermediate-dose methotrexate and high-dose cytarabine in the maintenance phase of the APO regimen: A Pediatric Oncology Group phase III trial
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DOI：
10.1200/jco.2005.11.075
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发表时间：
2005-01-20
影响因子：
45.3
通讯作者：
Murphy, SB
中科院分区：
文献类型：
--
作者：
Laver, JH;Kraveka, JM;Murphy, SB
目的儿科肿瘤组采用基于组织学的方法治疗非霍奇金淋巴瘤，并采用单独的方案（阿霉素、长春新碱、泼尼松、6-巯基嘌呤和甲氨蝶呤; APO方案）治疗晚期大细胞淋巴瘤患者。在这项研究中，我们评估的影响，一个强烈的抗代谢药物治疗交替与载脂蛋白O的总生存期（OS）和无事件生存期（EFS），并期待到生物correlated.Patients和方法从1994年12月至2000年4月，我们纳入了180名符合条件的儿科患者与阶段III/IV大细胞淋巴瘤（LCL）;根据研究设计，90例患者随机分配至中剂量甲氨蝶呤（IDM）和高剂量阿糖胞苷（HiDAC）组，85例患者分配至APO组，5例患者因CNS受累直接分配至APO组。结果全组患者4年无病生存率（EFS）为67.4%（SE，4.2%），总生存率（OS）为80.1%（SE，3.6%），两组间无显著性差异。间变性大细胞淋巴瘤患者的4年EFS和OS分别为71.8%（SE，6.1%）和88.1%（SE，4.4%），弥漫性大B细胞淋巴瘤患者的4年EFS和OS分别为63.8%（SE，10.3%）和70.3%（SE，9.0%）。只有11名患者需要放疗（由于无反应的巨大疾病或CNS受累）。IDM/HiDAC臂与更多的toxicity.Conclusion纳入IDM/HiDAC在治疗计划的儿童和青少年晚期LCL患者的疗效是不确定的，其对EFS的影响，无论淋巴瘤表型。不能排除的是，随着患者数量的增加，一种治疗可能被证明具有上级优势，未来的研究将建立在这些数据的基础上。(C)2005年，美国临床肿瘤学会。
Purpose The Pediatric Oncology Group adopted a histology-based approach to non-Hodgkin's lymphoma and treated patients with advanced large-cell lymphoma on a separate protocol (doxorubicin, vincristine, prednisone, 6-mercaptopurin, and methotrexate; APO regimen). In this study, we assessed the effects of an intense antimetabolite therapy alternating with APO on overall survival (OS) and event-free survival (EFS) and looked into biologic correlates.Patients and Methods From December 1994 to April 2000, we enrolled 180 eligible pediatric patients with stage III/IV large-cell lymphoma (LCL); 90 patients were randomly assigned to the intermediate-dose methotrexate (IDM) and high-dose cytarabine (HiDAC) arm, 85 patients to the APO arm, and five patients directly to the APO arm by study design due to CNS involvement. Planned therapy duration was 12 months.Results The 4-year EFS for all patients was 67.4% (SE, 4.2%), and OS was 80.1% (SE, 3.6%) without any significant difference between the two arms. The 4-year EFS and OS were 71.8% (SE, 6.1%) and 88.1% (SE, 4.4%), respectively, for patients with anaplastic large-cell lymphoma, and 63.8% (SE, 10.3%) and 70.3% (SE, 9.0%), respectively, for patients with diffuse large B-cell lymphoma. Only 11 patients required radiation (due to unresponsive bulky disease or CNS involvement). The IDM/HiDAC arm was associated with more toxicity.Conclusion The efficacy of incorporating IDM/HiDAC in the treatment plan of pediatric and adolescent patients with advanced-stage LCL was inconclusive as to its effect on EFS, regardless of the lymphoma phenotype. It cannot be excluded that with a higher number of patients, one treatment could prove superior and future studies will build on these data. (C) 2005 by American Society of Clinical Oncology.