含泊马度胺全口服方案二线治疗多发性骨髓瘤的疗效与安全性分析

Efficacy and Safety of Total Oral Regimens Containing Pomalidomide as a Second-line Treatment Strategy in Multiple Myeloma Patients

【目的】评价含泊马度胺全口服治疗方案二线治疗多发性骨髓瘤的疗效与安全性。【方法】回顾性分析2020年3月至2023年12月在我中心接受含泊马度胺全口服方案作为二线治疗的多发性骨髓瘤患者共22例,评价其疗效与安全性。【结果】22例患中位年龄为71.5岁,含泊马度胺的全口服二线治疗方案包括IPD 7例,PCD 11例,XPD 2例,PD 2例,中位治疗周期数为14,二线治疗ORR为63.64%,VGPR以上疗效为36.36%。有来那度胺暴露史的13例患者中,ORR为53.85%,VGPR以上疗效为23.08%;无来那度胺暴露史的9例患者中,ORR为77.78%,VGPR以上疗效为55.56%;两组ORR比较,差异无统计学意义(P=0.38)。伴遗传学高危的患者12例,ORR为50%,VGPR以上疗效为16.67%。整体中位随访时间10.6(2.0,39.3)个月,10例出现疾病进展,其中6例因原发病进展死亡,中位无进展生存期(PFS)尚未达到;其中来那度胺暴露的13例患者,中位PFS为10.6个月;非来那度胺暴露的9例患者,中位PFS未达到。≥3级不良事件占18.18%,包括粒细胞缺乏、血小板减少及肺部感染。没有导致死亡的治疗相关不良事件的发生。【结论】含泊马度胺全口服方案二线治疗多发性骨髓瘤具有较好的疗效及安全性,对有居家治疗意愿的老年多发性骨髓瘤患者具有积极的意义。

【Objective】To evaluate the efficacy and safety of total oral regimens containing pomalidomide as a second-line treatment strategy in multiple myeloma.【Methods】A total of 22 patients with multiple myeloma placed on total oral regimens containing pomalidomide as a second-line therapy from March 2020 to December 2023 were retrospectively analyzed to evaluate the treatment response,survival and safety.【Results】The median age of the 22 patients was 71.5 years old.The total oral treatment regimens containing pomalidomide included IPD(7 cases),PCD(11 cases),XPD(2 cases),and PD(2 cases).The median number of treatment cycles was 14.Among the 13 patients with prior lenalidomide exposure,ORR was 53.85%,of which 23.08%was≥VGPR.In 9 patients without prior lenalidomide exposure,the ORR was 77.78%,and of which 55.56%was≥VGPR.There was no significant difference in ORR between these two groups(P=0.38).In 12 patients with high genetic risk,the ORR was 50%,and≥VGPR was 16.67%.The median follow-up time was 10.6 months.Disease progressed in 10 patients and death occurred in 6 patients of them.The median progression free survival(PFS)was not reached(not reached and 10.6 months in non-lenalidomide-exposure patients or lenalidomide exposure patients,respectively).The high grade treatment-related adverse events(AEs)(≥3)were reported in 18.18%patients,including granulocytopenia,thrombocytopenia,and pulmonary infection.There was no treatment-related death.【Conclusion】Total oral regimens containing pomalidomide as a second-line therapy is generally effective and safe for multiple myeloma patients.