The impact of risk stratification by early bone-marrow response in childhood lymphoblastic leukaemia: results from the United Kingdom Medical Research Council trial ALL97 and ALL97/99
The impact of risk stratification by early bone-marrow response in childhood lymphoblastic leukaemia: results from the United Kingdom Medical Research Council trial ALL97 and ALL97/99
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DOI：
10.1111/j.1365-2141.2009.07769.x
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发表时间：
2009-08-01
影响因子：
6.5
通讯作者：
Eden, Tim
中科院分区：
文献类型：
--
作者：
Mitchell, Christopher;Payne, Jeanette;Eden, Tim
1997年急性淋巴细胞白血病（ALL）试验（ALL 97）是一项随机比较泼尼松龙与地塞米松和6-巯基嘌呤与6-硫鸟嘌呤的试验。在试验的前2年，生存数据审查显示，之前的试验UKALL XI并不比其前身更好，并且英国儿童ALL的生存率并未像其他合作治疗组那样得到改善。因此，将治疗模板改为美国儿童癌症组（CCG）式方案，包括按年龄分层、白色细胞计数和通过评估骨髓对治疗的早期反应。该试验阶段被指定为ALL 97/99。两个阶段的比较显示，ALL 97和ALL 97/99的无事件生存期（EFS）优于先前的UKALL试验，ALL 97/99的总生存期（OS）也是如此。ALL 97/99的EFS和OS均显着优于ALL 97（五年时，80个中心点0% vs 74个中心点0%，P = 0中心点002; 88个中心点0% vs 83个中心点5%，P = 0中心点005）。ALL 97/99中患者的孤立性中枢神经系统（CNS）复发率为ALL 97的一半（3个中心点0% vs. 4个中心点9%，P = 0中心点03），ALL 97/99中的总体CNS复发率为ALL 97/99的一半（4个中心点4% vs. 9个中心点6%，P < 0中心点00005）。两个试验阶段之间的非CNS复发、诱导期死亡或缓解期死亡无显著差异。
P>The 1997 acute lymphoblastic leukaemia (ALL) trial (ALL97) was a randomised comparison of prednisolone versus dexamethasone and of 6-mercaptopurine versus 6-thioguanine. During the first 2 years of the trial, review of survival data showed the preceding trial, UKALL XI, was no better than its predecessor and that survival for childhood ALL in the UK had not improved in the fashion witnessed by other cooperative treatment groups. The therapy template was therefore altered to an American Children's Cancer Group (CCG) style regimen, including stratification by age, white cell count and early response to therapy by assessment of the bone marrow. This phase of the trial was designated ALL97/99. Comparison of the two phases showed that the event-free survival (EFS) for both ALL97 and ALL97/99 was better than previous UKALL trials, as was overall survival (OS) for ALL97/99. Both EFS and OS were significantly better in ALL97/99 than in ALL97 (at five years, 80 center dot 0% vs. 74 center dot 0%, P = 0 center dot 002; and 88 center dot 0% vs. 83 center dot 5%, P = 0 center dot 005, respectively). Isolated central nervous system (CNS) relapse for patients in ALL97/99 was half that in ALL97 (3 center dot 0% vs. 4 center dot 9%), P = 0 center dot 03) and the overall CNS relapse rate was halved in ALL97/99 (4 center dot 4% vs. 9 center dot 6%, P < 0 center dot 00005). There were no significant differences for non-CNS relapse, induction deaths or deaths in remission between the two phases of the trial.