Gilchrist G S, Tubergen D G, Sather H N, Coccia P F, O'Brien R T, Waskerwitz M J, Hammond G D
Mayo Clinic, Rochester, MN.
J Clin Oncol. 1994 Dec;12(12):2594-600. doi: 10.1200/JCO.1994.12.12.2594.
This study was designed to evaluate the effect on CNS relapse (CNSR) and overall relapse rates of blast cells in the CSF containing < or = 5 cells/microL at the time of diagnosis of intermediate-risk acute lymphoblastic leukemia (ALL) in children entered onto a large randomized multicenter prospective therapeutic trial (Childrens Cancer Group [CCG]-105).
We studied outcome in terms of CNSR and event-free survival (EFS) in 1,544 patients who successfully completed remission-induction therapy and had been randomized to one of four systemic chemotherapy regimens and to one of two CNS prophylaxis regimens. We compared outcome between 1,450 patients who had varying degrees of pleocytosis but no blasts in the CSF at diagnosis (blast-negative group) with 94 who had blasts detected in the CSF after cytocentrifugation but had a total CSF WBC count of < or = 5/microL (blast-positive group).
No statistically significant differences in overall CNSR or EFS rates were observed between the two groups and no differences were found when analyzed according to age or WBC count at diagnosis, sex, or type of CNS prophylaxis (intrathecal [IT] methotrexate [MTX] alone v IT MTX plus 18 Gy cranial irradiation [CXRT]).
In intermediate-risk ALL, there was no significant difference in CNSR and systemic relapse rates after standard presymptomatic CNS therapy between patients with a CSF WBC count < or = 5/microL and those without identifiable blasts in the CSF. These findings suggest that certain approaches to therapy, such as that used in this study, may eliminate the need for any additional special treatment directed at this subset of patients with CSF blasts.
本研究旨在评估在一项大型随机多中心前瞻性治疗试验(儿童癌症组[CCG]-105)中,诊断为中度危险型儿童急性淋巴细胞白血病(ALL)时,脑脊液中原始细胞≤5个/微升对中枢神经系统复发(CNSR)和总复发率的影响。
我们研究了1544例成功完成缓解诱导治疗且被随机分配至四种全身化疗方案之一和两种中枢神经系统预防方案之一的患者的CNSR和无事件生存期(EFS)结局。我们比较了1450例诊断时脑脊液有不同程度细胞增多但无原始细胞的患者(原始细胞阴性组)与94例经细胞离心后脑脊液中检测到原始细胞但脑脊液白细胞总数≤5个/微升的患者(原始细胞阳性组)的结局。
两组之间在总体CNSR或EFS率方面未观察到统计学显著差异,根据诊断时的年龄、白细胞计数、性别或中枢神经系统预防类型(单纯鞘内[IT]甲氨蝶呤[MTX]与IT MTX加18 Gy颅脑照射[CXRT])进行分析时也未发现差异。
在中度危险型ALL中,脑脊液白细胞计数≤5个/微升的患者与脑脊液中无可识别原始细胞的患者在标准症状前中枢神经系统治疗后的CNSR和全身复发率无显著差异。这些发现表明,某些治疗方法,如本研究中使用的方法,可能无需针对脑脊液中有原始细胞的这部分患者进行任何额外的特殊治疗。