达雷妥尤单抗治疗复发/难治多发性骨髓瘤的疗效与安全性

目的探讨达雷妥尤单抗治疗复发/难治多发性骨髓瘤(RRMM)的疗效与安全性。方法回顾性分析2017年9月至2020年3月上海长征医院接受达雷妥尤单抗治疗的46例RRMM患者的临床资料。结果所有RRMM患者均采用以达雷妥尤单抗为基础的方案进行治疗,其中Dd(达雷妥尤单抗+地塞米松)方案组8例,DRd(达雷妥尤单抗+来那度胺+地塞米松)方案组35例,DVd(达雷妥尤单抗+硼替佐米+地塞米松)方案组3例。中位随访9.6个月,可评估疗效患者44例,总缓解率(ORR)75%完全缓解(CR)率18.2%]。对硼替佐米、来那度胺及两者均耐药患者的ORR分别为70.6%(CR率17.6%)、69.2%(CR率11.5%)和63.6%(CR率13.6%),三组间差异无统计学意义。DRd组、DVd组和Dd组的ORR分别为85.3%、66.7%和28.6%(P=0.007)。46例患者的中位无进展生存(PFS)时间为8.9个月,中位总生存(OS)时间未达到,1年OS率74%。DRd组中位PFS时间及OS时间较Dd组长(PFS时间:14.4个月对2.0个月;OS时间:未达到对5.2个月)。应用达雷妥尤单抗后,3级以上血液学不良反应以中性粒细胞减少最为常见,非血液学不良反应主要为输液相关不良反应和感染。预后分析显示伴髓外病灶患者的PFS时间和OS时间较不伴髓外病灶患者缩短(PFS时间:5.7个月对14.4个月,P=0.033;OS时间:6.3个月对未达到,P=0.029);ECOG评分3~4分患者的OS时间较ECOG评分1~2分患者缩短(5.9个月对未达到,P=0.004)。结论以达雷妥尤单抗为基础的方案治疗RRMM具有较好的疗效及安全性。

The efficacy and safety of daratumumab in relapsed and refractory multiple myeloma

Objective To investigate the efficacy and safety of daratumumab in relapsed and refractory multiple myeloma(RRMM).Methods The clinical characteristics,adverse reactions,efficacy,and prognosis of 46 patients with RRMM treated with daratumumab in Shanghai Changzheng Hospital from September 2017 to March 2020 were retrospectively analyzed.Results All patients were treated with daratumumab-based regimen:8 in the Dd group,35 in the DRd group,and 3 in the DVd group.With a median follow-up of 9.6 months,the overall response rate(ORR)was 75%complete remission(CR)rate 18.2%]among the 44 patients available for evaluation.The ORRs of patients resistant to bortezomib,lenalidomide,and both were 70.6%,69.2%,and 63.6%,respectively.The CR rates of patients resistant to bortezomib,lenalidomide,and both were 17.6%,11.5%,and 13.6%,respectively.No significant difference was observed in ORR and CR rates among the three groups.The ORRs of the DRd,DVd,and Dd groups were 85.3%,66.7%,and 28.6%,respectively(P=0.007).The median PFS of 46 patients was 8.9 months,the median OS was not reached,and the 1-year OS rate was 74%.The median PFS and OS in the DRd group were longer than those in the Dd group(PFS:14.4 months vs 2.0 months;OS:not reached vs 5.2 months).After treatment with daratumumab,neutropenia is the most common hematological adverse reaction above grade 3.Non-hematological adverse reactions are mainly infusion-related adverse reactions and infections.Prognostic analysis showed that patients with extramedullary invasion had shorter PFS and OS compard with patients without extramedullary invasion(PFS:5.7 vs 14.4 months,P=0.033;OS:6.3 months vs not reached,P=0.029).The OS of patients with an ECOG score of 3-4 was significantly shorter than patients with an ECOG score of 1-2(5.9 months vs not reached,P=0.004).Conclusion Daratumumab-based regimens have good efficacy and safety in the treatment of RRMM.