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目的由上海新华医院/上海儿童医学中心制定的治疗儿童急性淋巴细胞性白血病(ALL)的ALL-XH-99方案已在该院实施10年了。该文旨在评估应用此方案治疗儿童急性淋巴细胞性白血病(ALL)的疗效,并探讨儿童ALL的预后因素。方法回顾分析1998年1月~2007年4月在该院采用ALL-XH-99方案治疗的儿童ALL的临床资料。该研究在ALL-XH-99方案的基础上作了一些小的修订,即对高危患儿也未给予颅脑放射治疗。采用Kaplan-Meier方法评估患儿的无事生存率(EFS),组间患儿EFS差异用log-rank检验。采用逐步Cox比例风险模型分析ALL的预后因素。结果115例患儿得到了全程的ALL-XH-99方案治疗,其中低、中、高危患儿分别为62、12、41人。这115例患儿总的5年EFS率为(69.0±5.0)%,其中低危、中危、高危组5年的EFS率分别为(82.0±6.0)%、(77.0±15.0)%和(43.0±11.0)%(P<0.01)。16例(13.9%)复发,复发的中位时间为17个月。所有病例均未采取颅脑放疗,中枢神经系统白血病复发率(2/115,1.7%)并未高于既往报道。多因素分析显示白血病危险分度、t(9;22)/bcr/abl融合基因和白细胞计数是儿童ALL独立的不利预后因素,其风险比例分别为1.867、3.397和2.236。结论采用ALL-XH-99方案治疗儿童ALL疗效满意,取得了与发达国家类似的EFS率。t(9;22)/bcr/abl融合基因为儿童ALL最重要的不利预后因素。在强有力的系统化疗和鞘内注射条件下,对所有患儿可取消颅脑放疗以减少副作用。
Purpose The ALL-XH-99 regimen for the treatment of childhood acute lymphoblastic leukemia (ALL) developed by Shanghai Xinhua Hospital / Shanghai Children’s Medical Center has been implemented in this hospital for 10 years. This article aims to evaluate the efficacy of this regimen in the treatment of children with acute lymphoblastic leukemia (ALL) and to investigate the prognostic factors in children with ALL. Methods The clinical data of children with ALL treated with ALL-XH-99 regimen from January 1998 to April 2007 were retrospectively analyzed. The study made some minor revisions based on the ALL-XH-99 protocol, which also failed to give brain-based radiotherapy to high-risk children. The Kaplan-Meier method was used to assess the survival-free rate (EFS) in children. EFS differences between groups were compared by log-rank test. The prognostic factors of ALL were analyzed using a stepwise Cox proportional hazards model. Results A total of 115 children were treated with the ALL-XH-99 regimen, of which 62,12,41 were low, middle and high risk children. The overall 5-year EFS rate was (69.0 ± 5.0)% in these 115 cases. The 5-year EFS rates were (82.0 ± 6.0)%, (77.0 ± 15.0)% and 43.0 ± 11.0)% (P <0.01). Sixteen patients (13.9%) relapsed with a median recurrence of 17 months. No craniocerebral radiotherapy was taken in all cases. The recurrence rate of central nervous system leukemia (2 / 115,1.7%) was not higher than the previous reports. Multivariate analysis showed that the risk of leukemia, t (9; 22) / bcr / abl fusion gene and white blood cell count were independent adverse prognostic factors for childhood ALL, with risk ratios of 1.867, 3.397 and 2.236 respectively. Conclusions The ALL-XH-99 regimen is effective in treating children with ALL and has achieved similar EFS rates as developed countries. The t (9; 22) / bcr / abl fusion gene is the most important adverse prognostic factor for childhood ALL. Under strong systemic chemotherapy and intrathecal injection, cranial radiotherapy may be discontinued in all children to reduce side effects.