PD1抑制剂联合阿扎胞苷治疗高危骨髓增生异常综合征的临床研究

Clinical of PD1 Inhibitor Combination with Azacitidine in the Treatment of High-Risk Myelodysplastic Syndrome

目的研究PD1抑制剂联合阿扎胞苷(AZA)对高危骨髓增生异常综合征(MDS)的治疗效果。方法选取2019年6月至2023年2月于包头医学院第一附属医院、包头医学院第二附属医院接受治疗的MDS患者33例,随机分为研究组(16例)和对照组(17例)。研究组患者采用PD1抑制剂(信迪利单抗或派安普利单抗)联合AZA方案治疗,对照组患者采用AZA方案治疗。观察两组治疗1周期及两周期后总有效率(ORR)、1年及两年生存率、无进展生存期(PFS)、总生存期(OS)、输血依赖发生率及不良反应发生情况。结果研究组1年生存率(87.5%,14/16)高于对照组(29.4%,5/17),差异有统计学意义(P<0.05)。研究组中位PFS(26.0个月)明显长于对照组(18.0个月),差异有统计学意义(P<0.05)。研究组中位OS为26.0个月,对照组为21.0个月,两组差异无统计学意义(P>0.05)。研究组化疗后骨髓抑制发生率为50.0%(8/16),明显高于对照组的17.6%(3/17),差异有统计学意义(P<0.05)。结论PD1抑制剂联合AZA方案未明显增加治疗相关不良反应,虽然未增加短期内缓解率,但使无进展生存期明显延长,可以作为MDS提高疗效的备选方案。

Objective To investigate the therapeutic effects of the combination of PD1 inhibitor and azacitidine(AZA)in patients with high-risk myelodysplastic syndrome(MDS).Methods A total of 33 cases Thirty-three high-risk MDS patients who received treatment at the First Affiliated Hospital and the Second Affiliated Hospital of Baotou Medical College from June 2019 to February 2023 were randomly divided into a study group cases and a control group 17 cases.Patients in the study group were treated cases eity PD1 inhibitors(such as Sintilimab or Pembrolizumab)combined with the AZA regimen,while patients in the control group received only the AZA regimen.The observation included the total effective rate(ORR)after 1 and 2 treatment cycles,1-year and 2-year survival rates,progression-free survival(PFS),overall survival(OS),incidence of transfusion dependency,and occurrence of adverse reactions.Results The 1-year survival rate in the study group(87.5%,14/16)was higher than that in the control group(29.4%,5/17)(P<0.05).The median PFS in the study group(26.0 months)was significantly longer than that in the control group(18.0 months,P<0.05).The median OS was 26.0 months in the study group and 21.0 months in the control group,with no significant difference between the two groups(P>0.05).The incidence of bone marrow suppression after chemotherapy in the study group was 50.0%(8/16),significantly higher than that in the control group 17.6%(3/17)(P<0.05).Conclusion PD1 inhibitor combined with AZA regimen did not significantly increase the treatment-related adverse reactions,although it did not increase the short-term remission rate,but significantly prolonged the progression-free survival,which can be used as an alternative to improve the curative effect of high-risk MDS.