西达本胺联合化疗治疗复发难治性急性白血病患者38例

Chidamide combined with chemotherapy in treating 38 patients with relapsed/refractory acute leukemia

目的观察西达本胺联合化疗治疗复发、难治性急性白血病的临床疗效。方法回顾性分析2015年5月至2017年10月在本院治疗的复发、难治性急性白血病患者38例,其中急性髓系白血病(AML)及骨髓异常增生综合征EB2期(MDS-EB2)患者24例,急性淋巴细胞白血病(ALL)患者14例。≤14岁患者13例,> 14岁患者25例。所有患者给予二线化疗方案联合西达本胺治疗,成人给予西达本胺20 mg,患儿按实际体重/50 kg×20 mg给药,均口服,每周2次,连续给药1~3个月。计算患者总反应率(ORR)、完全缓解(CR)率和部分缓解(PR)率,并分析患者的年龄、性别、疾病种类等一般资料和染色体、基因的不同对疗效的影响。结果所有患者ORR为55%, CR率为37%。≤14岁患者ORR和CR率分别为69%和46%,均高于> 14岁患者(48%和32%),差异有显著意义(P <0.05)。不同性别和病种的患者, ORR和CR率均无显著差异(P> 0.05)。病程≤2个疗程未缓解(NR)的患者,其ORR和CR率分别为80%和53%,均高于病程> 2个疗程NR/复发患者(39%和26%),差异有显著意义(P <0.05)。MLL-PTD基因突变患者10例, ORR为60%, CR率为30%。染色体不同、基因突变或无突变患者的ORR和CR率均无显著差异(P> 0.05)。结论西达本胺联合化疗能有效改善复发、难治性急性白血病的ORR和CR率,在儿童中应用效果优于成人,早期应用效果优于晚期,在MLL-PTD突变患者中应用疗效良好。

AIM To observe the clinical efficacy of chidamide combined with chemotherapy in the treatment of relapsed/refractory acute leukemia.METHODS The retrospective analysis was performed on 38 patients with relapsed/refractory acute leukemia treated in our hospital from May 2015 to October 2017.Among them,24 cases were acute myeloid leukemia(AML)and myelodysplastic syndrome EB2(MDS-EB2),and 14 cases were acute lymphoblastic leukemia(ALL).Of all,13 cases were≤14 years old and 25 cases were>14 years old.All patients were treated with a second-line chemotherapy combined with chidamide(20 mg for adult patients and 20 mg×(actual weight of 50 kg)for children,po,biw)for 1 to 3 months.The overall response rate(ORR),complete remission(CR)rate and partial remission(PR)rate were observed and were compared according to the general data of age,sex,disease type,chromosome and gene.RESULTS All of the patients had ORR of 55%and CR rate of 37%.The ORR and CR rate of patients≤14 years old were 69%and 46%,respectively,which were higher than those of patients>14 years old(48%and 32%,P<0.05).There were no significant difference in ORR and CR rate among patients of different genders and diseases(P>0.05).The ORR and CR rate were 80%and 53%in not remission(NR)patients who had less than 2 courses of chemotherapies respectively,which were higher than those in NR or relapsed patients who had more than 2 courses of chemotherapies(39%and 26%,P<0.05).The ORR was 60%and CR rate was 30%in 10 patients with MLL-PTD gene mutations.There were no significant differences in ORR and CR rate between chromosomes normal and abnormal patients,and with or without gene mutations patients(P>0.05).CONCLUSION Chidamide combined with chemotherapy can effectively improve the ORR and CR rate of patients with relapsed/refractory acute leukemia.The efficacy in children is superior to that in adults,and better in early phase than in later phase.It has good curative effect in patients with MLL-PTD mutation.