Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study.
Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study.
复制标题
对患有晚期弥漫性大细胞非霍奇金淋巴瘤的儿童和青少年进行的随机 III 期试验的结果：一项儿科肿瘤学小组研究。
DOI：
10.1080/10428190210192
复制
发表时间：
2002
影响因子：
2.6
通讯作者：
Shuster,JonathanJ
中科院分区：
文献类型：
--
作者：
Laver,JosephH;Mahmoud,Hazem;Pick,TerryE;Hutchison,RobertE;Weinstein,HowardJ;Schwenn,Molly;Weitzman,Sheilah;Murphy,SharonB;Ochoa,Stephanie;Shuster,JonathanJ
目的儿科肿瘤学小组（POG）采用了一种基于组织学的方法，利用国家癌症研究所临床使用的工作方案来管理儿科非霍奇金淋巴瘤（NHL）。弥漫性大细胞淋巴瘤（DLCL）患者的治疗方案与小细胞弥漫性未分化或淋巴母细胞淋巴瘤不同。本研究评估了DLCL儿童的总体和无事件生存率，并确定了环磷酰胺对这些终点的影响，在前瞻性随机trial.Patients和methodsOne一百二十个符合条件的阶段III或IV NHL患者确诊弥漫性大细胞或免疫母细胞组织学的诊断在1986年10月和1991年11月之间的研究。患者随机接受或不接受环磷酰胺治疗; 58例接受环磷酰胺、多柔比星、长春新碱、6-巯基嘌呤（6-MP）和泼尼松（ACOP+）治疗，62例接受多柔比星、长春新碱、6-MP和泼尼松（APO）治疗。在两种治疗方案中，当阿霉素累积剂量达到450 mg/m2。如果在诱导治疗后观察到进展或无反应，则对巨大疾病进行放射治疗。计划的治疗时间为12 months.ResultsThe 5年无事件生存率（EFS）与ACOP+与APO治疗的患者分别为62 ± 7和72 ± 6%。虽然两个治疗组之间无统计学显著性差异（p =0.28），但我们只能说，我们有95%的把握认为5年EFS的差异福尔斯在28%（支持APO）至8%（支持ACOP+）的范围内。毒副反应以骨髓抑制为主，有1例感染死亡。研究期间，纵隔肿块患者中还有3例因呼吸衰竭死亡。仅1例患者发生心脏毒性，需要停用多柔比星。10例患者接受放射治疗，以实现remission.ConclusionThe疗效消除环磷酰胺的治疗方案的儿童和青少年晚期弥漫性大细胞淋巴瘤是不确定的，其对EFS的影响。此外，大多数患者（92%）不需要任何放射治疗，以巨大的疾病表明化疗方案是相当有效的实现完全缓解。
PurposeThe Pediatric Oncology Group (POG) adopted a histology-based approach to the management of pediatric non-Hodgkin's lymphomas (NHL) utilizing the National Cancer Institute Working Formulation for Clinical Usage. Patients with diffuse large cell lymphoma (DLCL) were treated on a separate protocol from small cell diffuse undifferentiated or lymphoblastic lymphomas. This study assessed the overall and event free survival of children with DLCL and determined the effects of cyclophosphamide upon these end-points in a prospective randomized trial.Patients and methodsOne hundred and twenty eligible stage III or IV NHL patients with the confirmed diagnosis of diffuse large cell or immunoblastic histology were enrolled on study between October 1986 and November 1991. Patients were randomized to receive or not receive cyclophosphamide; 58 received cyclophosphamide, doxorubicin, vincristine, 6-mercaptopurine (6-MP), and prednisone (ACOP+) and 62 were treated with doxorubicin, vincristine, 6-MP, and prednisone (APO). In both treatment programs methotrexate was substituted when the doxorubicin cumulative dose reached 450 mg/m 2. Radiation was administered to bulky disease if progression or no response were observed after induction therapy. Planned duration of therapy was 12 months.ResultsThe 5-year event free survival (EFS) rates of patients treated with ACOP+ versus APO were 62 ± 7 and 72 ± 6%, respectively. While there was no statistically significant difference between the two treatment arms (p =0.28), we can only say that we are 95% confident that the difference in 5-year EFS falls in the wide range from 28% in favor of APO to 8% favoring ACOP+. Marrow suppression was the main toxicity with one fatal infection. There were three other deaths on study due to respiratory failure in patients with mediastinal masses. Only one patient experienced cardiotoxicity requiring discontinuation of doxorubicin. Ten patients received radiation therapy to achieve remission.ConclusionThe efficacy of elimination of cyclophosphamide from the treatment program of children and adolescents with advanced stage diffuse large cell lymphoma was inconclusive as to its effect on EFS. Furthermore, the majority of the patients (92%) did not require any radiation therapy to bulky disease indicating that the chemotherapy regimens are quite efficient for achievement of complete remission.