Bleyer W A, Sather H N, Nickerson H J, Coccia P F, Finklestein J Z, Miller D R, Littman P S, Lukens J N, Siegel S E, Hammond G D
Children's Hospital and Medical Center, Seattle, WA.
J Clin Oncol. 1991 Jun;9(6):1012-21. doi: 10.1200/JCO.1991.9.6.1012.
On study CCG-161 of the Childrens Cancer Study Group (CCSG), 631 children with acute lymphoblastic leukemia (ALL) at low risk for relapse were randomized to receive monthly pulses of vincristine-prednisone (VCR-PDN ) during maintenance therapy in addition to standard therapy with mercaptopurine (6MP) and methotrexate (MTX), and either cranial irradiation during consolidation or intrathecal (IT) MTX every 3 months during maintenance. All patients received six doses of IT MTX during induction and consolidation. With a minimum follow-up time of 4.25 years, 76.7% receiving VCR-PDN were in continuous complete remission at 5 years, in contrast to 63.9% receiving GMP-MTX alone (P = .002). The difference in relapse-free survival was due primarily to bone marrow relapse (P = .0008), and in boys also to testicular relapse (P = .003). Among the nonirradiated patients, the 5-year disease-free survival (DFS) was 79.4% for patients randomized to the VCR-PDN pulses, in contrast to 61.2% for the patients randomized to receive 6MP-MTX alone (P = .0002). Among the irradiated patients, the DFS was not significantly different. Of the four combinations of maintenance and CNS therapy studied, the highest DFS was achieved with VCR-PDN pulses and maintenance IT MTX.
在儿童癌症研究组（CCSG）的CCG - 161研究中，631名复发风险低的急性淋巴细胞白血病（ALL）患儿被随机分组，在维持治疗期间除接受巯嘌呤（6MP）和甲氨蝶呤（MTX）的标准治疗外，每月接受长春新碱 - 泼尼松（VCR - PDN）脉冲治疗，并且在巩固治疗期间接受颅脑照射或在维持治疗期间每3个月接受鞘内注射（IT）MTX。所有患者在诱导和巩固治疗期间均接受6剂IT MTX。随访时间最短为4.25年，接受VCR - PDN治疗的患者5年持续完全缓解率为76.7%，相比之下，仅接受GMP - MTX治疗的患者为63.9%（P = 0.002）。无复发生存率的差异主要归因于骨髓复发（P = 0.0008），在男孩中还归因于睾丸复发（P = 0.003）。在未接受照射的患者中，随机接受VCR - PDN脉冲治疗的患者5年无病生存率（DFS）为79.4%，而随机接受仅6MP - MTX治疗的患者为61.2%（P = 0.0002）。在接受照射的患者中，DFS无显著差异。在所研究的维持治疗和中枢神经系统治疗的四种组合中，VCR - PDN脉冲治疗和维持IT MTX实现了最高的DFS。
