伊马替尼治疗儿童Ph阳性急性淋巴细胞白血病的疗效和安全性

目的 研究GGLG-08方案联合络氨酸激酶抑制剂(TKI)-伊马替尼治疗儿童Ph阳性急性淋巴细胞白血病(Ph+ ALL)的疗效及安全性。方法 回顾性分析2008年10月至2013年12月初诊年龄<15岁的53例Ph+ ALL患儿的临床资料,给予患儿CCLG-ALL2008(高危组 HR)方案化疗(HR组,26例)或伊马替尼联合CCLG-ALL2008(高危组 HR)方案化疗(TKI+HR组,27例),比较两组的疗效及不良反应。结果 TKI+HR组诱导治疗后完全缓解(CR)率为100%,诱导期相关病死率为0;HR组CR率为75%,诱导相关病死率为15%;HR组3年无事件生存率(EFS)为(6±5)%;TKI+HR组5年EFS为(52±11)%。与HR组比较,TKI+HR组未增加化疗相关毒性,诱导期感染发生率反而下降。结论 伊马替尼的应用使儿童Ph+ ALL的临床疗效获得明显改善,同时具有良好的安全性。

Efficacy and safety of imatinib for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia in children

Objective To study the efficacy and safety of Chinese Childhood Leukemia Group ALL 2008 (CCLG-ALL2008) protocol combined with tyrosine kinase inhibitor (TKI, imatinib) for the treatment of Philadelphia chromosome-positive (Ph⁺) acute lymphoblastic leukemia (ALL) in children. Methods The clinical data of 53 patients aged less than 15 years when first diagnosed with Ph⁺ ALL between October 2008 and December 2013 were retrospectively analyzed. The patients were assigned to two groups: HR (n=26) and HR+TKI (n=27). The HR group was treated with CCLG-ALL2008 protocol (for high-risk patients). The HR+TKI group was treated with imatinib in combination with CCLG-ALL2008 protocol (for high-risk patients). Results The complete remission rate and chemotherapy induction-related mortality rate in the TKI+HR and HR groups were 100% vs 75% and 0 vs 15%, respectively. The 3-year event-free survival (EFS) rate in the HR group was (6±5)%; the 5-year EFS rate of the TKI+HR group was (52±11)%. Compared with the HR group, the TKI+HR group had no increase in the toxic responses to chemotherapy and had a decrease in the infection rate during the induction period. Conclusions Application of imatinib significantly improves the clinical efficacy in children with Ph⁺ ALL and has good safety.