Tang Jing-yan, Gu Long-jun, Xue Hui-liang, Chen Jing, Pan Ci, Wu Wen-ting, Shen Shu-hong, Dong Lu, Zhou Min, Ye Qi-dong, Jiang Hua
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.
Zhonghua Xue Ye Xue Za Zhi. 2009 May;30(5):289-93.
To reduce the risk of infection during the induction therapy while to ensure remission rates, and to evaluate the protocol ALL-2005.
The minimal residual disease (MRD) was detected by flow cytometry on day 35 and 55 of induction therapy. The efficacy of induction and the clinic grouping were evaluated by MRD level. From May 1, 2005 to April 30, 2007, 158 children with newly diagnosed ALL were enrolled in this study. According to clinic grouping criteria of ALL-2005, patients were stratified into 3 groups: low-risk( LR), intermediate-risk (MR) and high-risk (HR). The remission rates, therapy related complication during induction, and the relationship between MRD level on day 35 and 55 of induction and prognosis were analyzed. The endpoints are disease-free survival (DFS), relapse and death of any cause. Patients lost to follow-up were censored at the time of their withdrawal.
Of the 158 patients, 59 were LR, 93 MR and 6 HR. The CR rate on day 35 was 98.1%. There were detectable MRD in 139 (88.0%) patients. In 94 patients (68.6%) MRDs were < or = 0.01% on day 35 being 73.1% (49/67) for LR and 63.4% (45/71) for MR (P = 0.219). During induction therapy, 43 patients (27.2%) developed infection and among them 1.3% (2/158) suffered serious infection and 0.6% (1/158) died of complication. Four patients (2.5%) in CR were lost follow-up, 17 patients (10.8%) relapsed, including 4 patients (4.3%) with MRD < or = 0.01% and 10 (23.3%) >0.01% on day 35 (P = 0.003). One died of severe malnutrition and infection in CR. With a median follow-up of 20 (12-35) months, the estimated 30 month DFS for whole group was (81.6 +/- 4.5)% including (94.1 +/- 3.3)% for LR, (82.8 +/- 4.4)% for MR, and (91.0 +/- 5.4)% for MRD < or = 0.01%, (67.1 +/- 9.5)% for MRD >0.01% on day 35 and (89.1 +/- 5.3)% for MRD < or = 0.01% and (46.9 +/- 15.6)% for MRD >0.01% on day 55.
The risk of infection and therapy related death during induction with protocol ALL-2005 are lower, while the remission rate and quality of the induction are better. Longer follow-up is needed to estimate the long-term result.
在确保缓解率的同时降低诱导治疗期间的感染风险，并评估ALL-2005方案。
在诱导治疗的第35天和第55天通过流式细胞术检测微小残留病（MRD）。根据MRD水平评估诱导疗效和临床分组。2005年5月1日至2007年4月30日，158例新诊断的ALL儿童纳入本研究。根据ALL-2005的临床分组标准，患者被分为3组：低危（LR）、中危（MR）和高危（HR）。分析缓解率、诱导期间与治疗相关的并发症，以及诱导第35天和第55天的MRD水平与预后的关系。终点指标为无病生存期（DFS）、复发和任何原因导致的死亡。失访患者在退出时进行截尾。
158例患者中，59例为LR，93例为MR，6例为HR。第35天的CR率为98.1%。139例（88.0%）患者可检测到MRD。94例（68.6%）患者在第35天的MRD≤0.01%，LR组为73.1%（49/67），MR组为63.4%（45/71）（P = 0.219）。诱导治疗期间，43例（27.2%）患者发生感染，其中1.3%（2/158）发生严重感染，0.6%（1/158）死于并发症。4例（2.5%）CR患者失访，17例（10.8%）复发，包括第35天MRD≤0.01%的4例（4.3%）和>0.01%的10例（23.3%）（P = 0.003）。1例CR患者死于严重营养不良和感染。中位随访20（12 - 35）个月，全组30个月的DFS估计值为（81.6±4.5）%，其中LR组为（94.1±3.3）%，MR组为（82.8±4.4）%，第35天MRD≤0.01%的为（91.0±5.4）%，>0.01%的为（67.1±9.5）%，第55天MRD≤0.01%的为（89.1±5.3）%，>0.01%的为（46.9±15.6）%。
ALL-2005方案诱导治疗期间的感染风险和与治疗相关的死亡风险较低，而诱导缓解率和质量较好。需要更长时间的随访来评估长期结果。
