Richards S, Burrett J, Hann I, Chessells J, Hill F, Bailey C
Clinical Trial Service Unit, Oxford, UK.
Leukemia. 1998 Jul;12(7):1031-6. doi: 10.1038/sj.leu.2401065.
The Medical Research Council (MRC) United Kingdom trial for childhood acute lymphoblastic leukaemia (UKALL X) randomised patients aged 0-14 years inclusive with an initial white blood count of less than 100 x 10(9)/l to receive an early intensification block, a late intensification block, both, or neither. The next trial, UKALL XI, for children aged 1-14 years, randomised between different central nervous system (CNS) directed therapies. At the beginning of the trial, all patients were also randomised between late intensification alone and both early plus late blocks. The effects of both the early and the late block in UKALL X alone have been reported previously. This paper examines the effect of the addition of the early intensification block to treatment which included late intensification, combining the data from UKALL X and the first part of UKALL XI. Early intensification was associated with fewer bone marrow relapses and a reduction in the odds of death of 0.63 (95% confidence interval: 0.46-0.87). Survival was significantly improved with an increase at 5 years of 8%, from 79 to 87%. Following this demonstration that early intensification improves survival, the effect of a third intensification block is under investigation.
英国医学研究理事会(MRC)针对儿童急性淋巴细胞白血病的试验(UKALL X),将年龄在0至14岁(含)且初始白细胞计数低于100×10⁹/L的患者随机分组,分别接受早期强化疗程、晚期强化疗程、两者皆接受或两者皆不接受。下一项试验UKALL XI针对1至14岁儿童,在不同的中枢神经系统(CNS)定向治疗方案之间进行随机分组。在试验开始时,所有患者还在仅接受晚期强化与同时接受早期和晚期强化疗程之间进行随机分组。此前已报道过UKALL X中早期强化疗程和晚期强化疗程各自的效果。本文结合UKALL X和UKALL XI第一部分的数据,研究在包含晚期强化的治疗方案中加入早期强化疗程的效果。早期强化与骨髓复发减少相关,死亡几率降低0.63(95%置信区间:0.46 - 0.87)。生存率显著提高,5年生存率从79%升至87%,提高了8%。在证实早期强化可提高生存率之后,正在研究第三个强化疗程的效果。