Department of Hematology-Oncology, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.
Pediatr Blood Cancer. 2011 Jul 15;57(1):47-55. doi: 10.1002/pbc.23097. Epub 2011 Mar 10.
Our aim was to compare two different schedules of maintenance in pediatric acute lymphoblastic leukemia (ALL) treated with a BFM-based therapy, in a randomized study: an Arm with 6-MP + MTX (with or without vincristine and dexamethasone pulses) versus a more intensive continuation phase.
From January 1996 to November 2002, 429 eligible children with ALL were enrolled in a protocol with BFM-based back-bone, followed by a randomized continuation phase in standard (SRG) and intermediate (IRG) risk groups. Patients were randomized between Arms A and B for SRG and B or C for IRG. Arms A and C consisted of 6-MP and MTX and in Arm C, six pulses of VCR and dexamethasone were added. Arm B combined four pairs of drugs rotated weekly. All risk-groups received maintenance until completing 2 years of therapy from diagnosis.
With a median follow-up of 138 (range: 96-178) months, the overall pEFS (SE) was 72 (6)% for all patients and the different risk groups showed: SRG: 85 (3)%, IRG: 71 (1)%, and HRG: 42 (7)% (P-value ≤ 0.0001). The pDFS (SE) according to the assigned arm of maintenance was, for Arm A: 89 (3)% and for Arm B: 85 (4)% in SRG, and, for Arm B: 77 (4)% and for Arm C: 75 (4)% in IRG, at 10 years follow-up. There were no statistically significant differences in outcome between arms of maintenance for both risk groups.
In protocols with initial BFM-based strategy, a more intensive continuation phase did not benefit any risk group of patients.
我们的目的是在一项基于 BFM 的治疗方案治疗的小儿急性淋巴细胞白血病（ALL）中，比较两种不同的维持治疗方案：一组为 6-MP+MTX（加或不加长春新碱和地塞米松脉冲），另一组为更强化的延续期治疗。
从 1996 年 1 月至 2002 年 11 月，429 例符合条件的 ALL 患儿入组了一项基于 BFM 为基础的方案，随后在标准（SRG）和中危（IRG）风险组中进行了随机延续期治疗。患者在 SRG 中随机分为 A 组和 B 组，在 IRG 中随机分为 B 组或 C 组。A 组和 C 组包含 6-MP 和 MTX，在 C 组中，加入了 6 个长春新碱和地塞米松脉冲。B 组每周轮换使用四对药物。所有风险组患者均接受维持治疗，直至从诊断开始完成 2 年治疗。
中位随访 138 个月（范围：96-178），所有患者的总体 pEFS（SE）为 72（6）%，不同风险组显示：SRG：85（3）%，IRG：71（1）%，HRG：42（7）%（P 值≤0.0001）。根据维持治疗分配臂的 pDFS（SE）为，A 组：SRG 为 89（3）%，B 组为 85（4）%，B 组：IRG 为 77（4）%，C 组为 75（4）%，在 10 年随访时。对于两个风险组，维持治疗组之间的结果没有统计学上的显著差异。
在基于 BFM 的初始策略方案中，更强化的延续期治疗对任何风险组患者均无获益。
