Objective: To investigate the efficacy, prognosis and safety of decitabine combined with modified EIAG regimen in the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Methods: The clinical data of 44 patients with relapsed/refractory AML and high-risk MDS admitted to our hospital from January 2017 to December 2020 were analyzed retrospectively. The patients were equally divided into D-EIAG group (decitabine combined with EIAG regimen) and D-CAG group (decitabine combined with CAG regimen) according to clinical treatment regimen. The complete response (CR), CR with incomplete hematologic recover (CRi), morphologic leukemia-free state (MLFS), partial response (PR), overall response rate (ORR), modified composite complete response (mCRc), overall survival (OS) time, 1-year OS rate, myelosuppression and adverse reactions between the two groups were compared.
Results: In D-EIAG group, 16 patients (72.7%) achieved mCRc (CR+CRi+MLFS), 3 patients (13.6%) achieved PR, and ORR (mCRc+PR) was 86.4%. In D-CAG group, 9 patients (40.9%) achieved mCRc, 6 patients (27.3%) achieved PR, and ORR was 68.2%. Difference was observed in mCRc rate between the two groups (P=0.035), but not in ORR (P>0.05). The median OS time of D-EIAG group and D-CAG group was 20 (2-38) months and 16 (3-32) months, and 1-year OS rate was 72.7% and 59.1%, respectively. There was no significant difference in 1-year OS rate between the two groups (P>0.05). After induction chemotherapy, the median time for absolute neutrophil count recovery to 0.5×109/L in D-EIAG group and D-CAG group was 14 (10-27) d and 12 (10-26) d, for platelet count recovery to 20×109/L was 15 (11-28) d and 14 (11-24)d, the median red blood cell suspension transfusion volume was 8 (6-12) U and 6 (6-12) U, and the median apheresis platelet transfusion volume was 4 (2-8) U and 3 (2-6) U, respectively. There were no statistically significant differences in comparison of the above indicators between the two groups (P>0.05). The hematological adverse reactions of patients were mainly myelosuppression. Grade III-IV hematological adverse events occurred in both groups (100%), with no increase in the incidence of non-hematological toxicities such as gastrointestinal reactions or liver function damage.
Conclusion: Decitabine combined with EIAG regimen in the treatment of relapsed/refractory AML and high-risk MDS can improve remission rate, provide an opportunity for subsequent therapies, and have no increase in adverse reactions compared with D-CAG regimen.
题目: 地西他滨联合改良EIAG方案治疗复发/难治AML及高危MDS疗效及安全性分析.
目的: 探讨地西他滨联合EIAG方案治疗复发/难治急性髓系白血病（AML）和高危骨髓增生异常综合征 （MDS）患者的疗效、预后及安全性。.
方法: 回顾性分析2017年1月至2020年12月我院收治的44例复发/难治AML及高危MDS患者的临床资料，按照临床治疗方案不同将患者分为D-EIAG组和D-CAG组，各22例。D-EIAG组采用地西他滨联合EIAG方案，D-CAG组采用D-CAG方案。比较两组患者的改良复合完全缓解率（mCRc=CR+CRi+形态学无白血病状态）、总有效率（ORR=mCRc+PR）、总生存时间（OS）、1年OS率、骨髓抑制以及不良反应情况。.
结果: D-EIAG组mCRc 16例（72.7%），PR 3例（13.6%），ORR为86.4%；D-CAG组mCRc 9例（40.9%），PR 6例 （27.3%），ORR为68.2%，两组mCRc率比较，差异具有统计学意义（P=0.035），而ORR率比较无差异（P>0.05）。D-EIAG组中位OS时间为20（2-38）个月，1年OS率为72.7%；D-CAG组中位OS时间为16（3-32）个月，1年OS率为59.1%，两组患者1年OS率比较，差异无统计学意义（P>0.05）。诱导化疗后D-EIAG组和D-CAG组中性粒细胞数恢复至>0.5×109/L的中位时间分别为14（10-27）d、12（10-26）d，血小板数恢复至>20×109/L的中位时间分别为15（11-28）d、14（11-24）d，中位红细胞悬液输注量分别为8（6-12）U、6（6-12）U，中位机采血小板输注量分别为4（2-8）U、3（2-6）U，两组比较差异均无有统计学意义（P>0.05）。患者血液学不良反应主要是骨髓抑制，两组患者均发生了Ⅲ-Ⅳ级血液学不良反应（100%），非血液学毒性如胃肠道反应、肝功能损害等不良反应发生率无增加。.
结论: 地西他滨联合EIAG方案治疗复发/难治AML可提高缓解率，为争取后续治疗提供机会，且与D-CAG方案相比不良反应无增加。.
Keywords: EIAG regimen; decitabine; myelodysplastic syndrome; relapsed/refractory acute myeloid leukemia.