摘要目的 比较传统Hyper-CVAD/MA方案及借鉴儿童急性淋巴细胞白血病(ALL)的新化疗方案CHALL-01在≤60岁成人Ph阳性ALL(Ph+ALL)中的临床疗效.方法 回顾性分析2007年1月至2017年12月第二军医大学附属长海医院及长征医院收治的158例Ph+ALL患者(除外慢性髓性白血病急变期患者),其中Hyper-CVAD/MA组63例,CHALL-01组95例,诱导及巩固化疗期间联合酪氨酸激酶抑制剂(TKI)治疗,有合适供者的患者进行造血干细胞移植,并用TKI进行维持治疗.结果经过1～2个疗程的诱导治疗,91.1％(144/158)患者获得完全缓解(CR),其中Hyper-CVAD/MA组CR率为90.5％(57/63),CHALL-01组CR率为91.6％(87/95),两组间差异无统计学意义(χ2=0.057,P=0.811).随访截止于2018年6月,共134例CR患者可进一步分析,其中Hyper-CVAD/MA组53例,CHALL-01组81例.CHALL-01组达到分子学缓解的比例显著高于Hyper-CVAD/MA组(完全分子学反应率:44.4％对22.6％,主要分子学反应率:9.9％对18.9％)(χ2=7.216,P=0.027).Hyper-CVAD/MA组和CHALL-01组4年总生存率分别为44.81％(95％CI 30.80％～57.86％)和55.63％(95％CI 39.07％～69.36％)(P=0.037),4年无病生存率分别为37.95％(95％CI 24.87％～50.93％)和49.06％(95％CI 34.24％～62.29％)(P=0.015).两组在4年累积复发率(P=0.328)及无复发死亡率(P=0.138)上差异无统计学意义.CHALL-01组肺部感染发生率较Hyper-CVAD/MA组明显减低(43.4％对67.9％,χ2=7.908,P=0.005).结论 CHALL-01方案治疗成人Ph+ALL疗效优于Hyper-CVAD/MA方案,肺部感染发生率低,分子学缓解率高,可以提高Ph+ALL患者的生存率.

abstractsObjective To compare the difference of efficacy between traditional Hyper-CVAD/MA regimen and the adolescents inspired chemotherapy regimen, CH ALL-01, in treatment of adult Philadelphia chromosome-positive acute lymphoblastic leukemia(Ph+ALL). Methods In this study we retrospectively analyzed 158 Ph+ALL patients receiving Hyper-CVAD/MA regimen(n=63)or CHALL-01 regimen(n=95)in our center and Changzheng hospital from January 2007 to December 2017, excluding patients with chronic myeloid leukemia in blast crisis. Tyrosine kinase inhibitor(TKI)was administered during induction and consolidation chemotherapy. Patients who underwent hematopoietic stem cell transplantation received TKI as maintenance therapy. Results Of them, 91.1％(144/158) patients achieved complete remission(CR)after 1-2 courses of induction. CR rate was 90.5％(57/63)for patients in Hyper-CVAD/MA group and 91.6％(87/95)for patients in CHALL-01 group. There was no difference in CR rates between the two groups(χ2=0.057, P=0.811). The last follow-up was June 2018. A cohort of 134 CR patients could be used for further analysis, among them, 53 patients received Hyper-CVAD/MA regimen and other 81 patients received CHALL- 01 regimen. The molecular remission rates were significantly higher in CHALL-01 group(complete molecular response:44.4％vs 22.6％;major molecular response:9.9％vs 18.9％)(χ2=7.216, P=0.027). For the patients in Hyper-CVAD/MA group, the 4-year overall survival (OS) was 44.81％(95％CI: 30.80％-57.86％) and the 4-year disease free survival (DFS)was 37.95％(95％CI: 24.87％-50.93％). For patients received CHALL-01 regimen, the 4-year OS was 55.63％(95％CI:39.07％-69.36％)(P=0.037)and 4 year DFS was 49.06％(95％CI:34.24％-62.29％)(P=0.015), while there was no significant difference in 4 year cumulative incidence of relapse(CIR)(P=0.328)or cumulative incidence of nonrelapse mortality(CI-NRM)(P=0.138). The rate of pulmonary infection was lower in patients received CHALL-01 regimen compared with patients received Hyper-CVAD regimen(43.4％ vs 67.9％, χ2=7.908, P=0.005). Conclusions Outcome with CHALL-01 regimen appeared better than that with the Hyper-CVAD/MA regimen in Ph+ALL, which has lower incidence of pulmonary infection, higher molecular remission rate and better OS and DFS.