Tubergen D G, Krailo M D, Meadows A T, Rosenstock J, Kadin M, Morse M, King D, Steinherz P G, Kersey J H
University of Texas M.D. Anderson Cancer Center, Houston, USA.
J Clin Oncol. 1995 Jun;13(6):1368-76. doi: 10.1200/JCO.1995.13.6.1368.
Patients with lymphoblastic non-Hodgkin's lymphoma (LB NHL) were randomized to treatment with either modified LSA2L2 or ADCOMP, which added daunorubicin (DAUN) and asparaginase (L-ASP) to the methotrexate (MTX), cyclophosphamide (CYT), vincristine (VCR), and prednisone (PRED) (COMP) regimen, in a clinical trial to determine the relative effectiveness and toxicity of the two regimens.
Patients with LB NHL were eligible for this randomized study if they were less than 22 years of age at diagnosis and had < or = 25% blasts in the bone marrow. Of 307 patients registered, 281 were fully eligible and assessable. Patients were stratified by extent of disease at diagnosis.
The 5-year event-free survival (EFS) rate for patients with localized disease was 84%, and for patients with disseminated disease, 67%. There were four relapses in 28 patients with localized disease. Two hundred six patients had mediastinal primary tumors and despite local radiation, 34 of 63 failures in these patients involved the primary tumor site with or without other involvement. After adjusting for extent of disease at diagnosis, the regimens did not differ significantly with respect to risk for adverse events. The acute toxicity was primarily neutropenia and thrombocytopenia, with greater initial toxicity in patients on the LSA2L2 regimen. Three patients developed acute myelogenous leukemia.
Long-term EFS in children with LB NHL can be achieved in the majority of patients. Disease progression, which includes recurrence at the primary tumor site, is a major cause of treatment failure in patients with mediastinal presentations. Addition of DAUN and L-ASP to the COMP regimen does not produce a more effective treatment than LSA2L2.
在一项临床试验中,将淋巴细胞性非霍奇金淋巴瘤(LB NHL)患者随机分为接受改良LSA2L2方案或ADCOMP方案治疗,ADCOMP方案是在甲氨蝶呤(MTX)、环磷酰胺(CYT)、长春新碱(VCR)和泼尼松(PRED)(COMP)方案基础上加用柔红霉素(DAUN)和天冬酰胺酶(L-ASP),以确定两种方案的相对有效性和毒性。
诊断时年龄小于22岁且骨髓中原始细胞≤25%的LB NHL患者符合本随机研究的条件。在登记的307例患者中,281例完全符合条件且可评估。患者按诊断时疾病范围分层。
局限性疾病患者的5年无事件生存率(EFS)为84%,播散性疾病患者为67%。28例局限性疾病患者中有4例复发。206例患者有纵隔原发性肿瘤,尽管进行了局部放疗,但这些患者中63例治疗失败的患者中有34例涉及原发性肿瘤部位,伴或不伴有其他部位受累。在调整诊断时的疾病范围后,两种方案在不良事件风险方面无显著差异。急性毒性主要为中性粒细胞减少和血小板减少,LSA2L2方案患者的初始毒性更大。3例患者发生急性髓性白血病。
大多数LB NHL儿童患者可实现长期EFS。疾病进展,包括原发性肿瘤部位复发,是纵隔型患者治疗失败的主要原因。在COMP方案中加用DAUN和L-ASP并不比LSA2L2方案产生更有效的治疗效果。