年长儿童及青少年急性淋巴细胞白血病多中心临床研究  

Multicenter clinical trial of acute lymphoblastic leukemia in elder children and adolescents

作　　者：张娜[1] 沈树红[2] 王宁玲[3] 李红[1] 杨静薇[1] 邵静波[1] 蒋慧[1] 汤静燕[2] Zhang Na;Shen Shuhong;Wang Ningling;Li Hong;Yang Jingwei;Shao Jinbo;Jiang Hui;Tang Jingyan(Department of Hematology/Oncology,Shanghai Children＇s Hospital,Shanghai Jiao Tong University,Shanghai 200040,China;Department of Hematology/Oncology,Shanghai Children＇s Medical Center,Shanghai Jiao Tong University school of Medicine,Shanghai 200127,China)

机构地区：[1]上海市儿童医院、上海交通大学附属儿童医院血液/肿瘤科,200040 [2]上海交通大学医学院附属上海儿童医学中心血液/肿瘤科 [3]安徽医科大学第二附属医院血液科

出　　处：《中华血液学杂志》2018年第9期717-723,共7页Chinese Journal of Hematology

基　　金：上海市科学技术委员会科研计划项目课题（14411950600）

摘　　要：目的分析10岁以上儿童和青少年急性淋巴细胞向血病（ALL）的临床特征，评价多中心协作组方案的远期疗效。方法收集2005年5月1日至2015年4月30日初发的10～18岁ALL患儿的临床资料，采用ALL-2005／2009方案治疗，分析其临床特征、疗效及预后差异。结果共入组237例ALL患儿，ALL-2005方案治疗76例，ALL-2009方案治疗161例。初治诱导治疗完全缓解率为94．5％；64例（28．6％）复发，中位复发时间为14．5（3—79）个月；70例（29．5％）死亡。中位随访65（25～130）个月，5年无事件生存（EFS）率与5年总生存（OS）率分别为（63．1±3．3）％和（68．4±3．2）％；7年EFS率与OS率分别为（61．0±3．5）％和（67．6±3．3）％。ALL-2005和ALL-2009方案中危组5年EFS率为（73．6±6．1）％和（71．7±4．3）％，差异无统计学意义（X2=0．064，P=0．801）。ALL-2005和ALL-2009方案高危组5年EFS率分别为（27．6±9．6）％和（33．9±9．3）％，差异无统计学意义（X2=0．296，P=0．586）。ALL-2005和ALL-2009方案组5年累积复发率分别为（33．8±5．7）％和（32．6±4．1）％，差异无统计学意义（X2=0．055，P=0．815）。两组病死率分别为36．8％和29．8％，差异无统计学意义（X2=2．869，P=0．090）。影响预后的单因素分析显示，年龄大、男性、危险度分组高危、BCR—ABL或Ph阳性、诱导治疗未缓解是影响预后的危险因素（X2值分别为4．764、4．796、46．410、9．560、25．450；P值分别为0．029、0．029、〈0．001、0．049、〈0．001）。Cox回归多因素分析显示：男性、危险度分组高危、诱导治疗未缓解是影响预后的独立危险因素（RR值分别为1．790、2．727、2．719；P值分别为0．021、0．000、O．012）。结论ALL-2009方案较ALL-2005方案增强了中危组的化疗强度，但未改善该组的预后。BCR-ABL阳性或t（9；22）染色体异常是影响患者预Objective To analyze the clinical characteristics and long-term outcomes with multicenter study for acute lymphoblastic leukemia （ALL） in children over 10 years old and adolescents. Method Newly diagnosed ALL patients aged from 10 to 18 years old in three hospitals were included in the study from May 1st 2005 to April 30th 2015. They were received ALL-2005/2009 protocol following up to December 31st 2016. The clinical characteristics, outcomes and the prognostic analysis were evaluated between the two protocols. Results Totally, 237 patients were involved in the study, 76 cases for ALL- 2005 and 161 cases for ALL-2009 protocol. Complete remission （CR） after induction therapy was 94.5%. 64 （28.6%） patients relapsed with a median time of 14.5 months and 70 （29.5%） patients passed away during the following time. In long-term follow-up, the 5-year event-free survival （EFS） and 5-year overall survival （OS） of ALL patients were （63.1±3.3）% and （68.4±3.2）%. The 7-year EFS and OS were （61.0±3.5）% and （67.6±3.3）%.The 5-year EFS of intermediate risk group in ALL-2005 and ALL-2009 protocol were （73.6±6.1）% and （71.7±4.3）% with no difference （X2= 0.064, P = 0.801）. The 5-year EFS of high risk group in two protocols were （27.6±9.6）% and （33.9±9.3）%, showing no significant difference （X2 = 0.296, P = 0.586）. Five years relapsed rate of two protocols were （33.8±5.7）% and （32.6±4.1）% with no difference （X2=0.055, P=0.815）. The mortalities were 36.8% and 29.8% separately （X2=2.869, P=0.090）. Univariate analysis indicated that age, male, risk, BCR/ABL translocation/t（9;22） and resistant to induction were risk prognostic factors in long-term survival （1,2=4.764, 4.796, 46.410, 9.560, 25.450; P=0.029, 0.029, 〈 0.001, 0.049, 〈 0.001）. Cox multivariate analysis showed male, risk and resistant to induction were independent risk prognostic factors （RR = 1.790, 2.727, 2.719; P = 0.021, 0.000, 0.012）. Conclusion Protocol ALL-2009 enha

关 键 词：白血病 淋巴样 儿童 青少年 无病生存率 

分 类 号：R733.71[医药卫生—肿瘤]