摘要目的: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。

abstractsObjective: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.