Efficacy observation of selinexor-based regimen in the treatment of 10 patients with relapsed/refractory multiple myeloma
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摘要: 目的 观察塞利尼索治疗复发难治多发性骨髓瘤的疗效及不良反应。方法 回顾性分析河南省肿瘤医院2021年6月—2022年6月采用塞利尼索治疗的10例复发难治多发性骨髓瘤患者的临床资料，随访分析其疗效及不良反应。结果 10例患者中男7例，女3例；中位年龄61.5(47.0~73.0)岁；诊断中位时间19.5(8.0~72.0)个月；中位既往治疗线数为4(3~8)线。所有患者均对蛋白酶体抑制剂和免疫调节剂双重难治，其中四药和五药难治的患者分别为4例、1例。所有患者均采用塞利尼索为基础方案治疗，其中Sd方案组3例，SRd方案组1例，SPd方案组6例，总缓解率为70%(7/10)，其中完全缓解1例(10%)，非常好的部分缓解1例(10%)，部分缓解5例(50%)，疾病稳定3例(30%)。常见的不良反应主要是胃肠道反应、血小板减少、中性粒细胞减少、贫血等，经对症治疗及调整用药剂量后可改善。结论 塞利尼索为基础方案治疗复发难治多发性骨髓瘤疗效好，安全性可控。Abstract: Objective To investigate the efficacy and safety of selinexor in the treatment of relapsed/refractory multiple myeloma(RRMM).Methods From June 2021 to June 2022, 10 patients with relapsed/refractory multiple myeloma treated with selinexor were selected from Department of Hematology, Henan Cancer Hospital. The clinical data, follow-up response and adverse events were retrospectively analyzed.Results There were 7 males and 3 females, and the median age of 10 patients was 61.5(47.0-73.0) years; the median time for the diagnosis was 19.5(8.0-72.0) months; the median number of previous treatment lines was 4(3-8); All patients were refractory to both PIs and IMiDs, 4 patients were refractory to four drugs and 1 patient was refractory to five drugs. All patients were treated with selinexor-based regimen: 3 cases in the Sd group, 1 case in the SRd group, and 6 cases in the SPd group. The overall response rate was 70%(7/10), including one case of complete response(10%), one case of very good partial response(10%), five cases of partial response(50%), three cases of stable disease(30%). The common adverse events were mainly gastrointestinal tract reaction, thrombocytopenia, neutropenia and anemia. All the adverse events were manageable with symptomatic therapy and(or) dose modification.Conclusion Selinexor-based regimen is effective and safe in the treatment of RRMM.
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Key words:
- multiple myeloma /
- selinexor /
- relapsed/refractory
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表 1 10例RRMM患者的临床资料
序号 年龄/岁 性别 诊断时间/月 类型 DS分期 ISS分期 难治药物 治疗线数 FISH 髓外病变 1 67 女 24 IgGκ Ⅲ A Ⅱ Bor/Len/Ixa/Pom 7 FGFR3/IgH融合 否 2 61 女 51 IgGκ Ⅲ A Ⅲ Bor/Len/Ixa 7 1q21扩增 否 3 62 男 20 IgGλ Ⅱ B Ⅲ Ixa/Len/Dara/Pom 4 1q21扩增，RB1缺失 是 4 61 男 72 IgGλ Ⅱ A Ⅲ Bor/Len/Ixa/Pom 4 正常 否 5 56 男 18 IgAκ Ⅲ A Ⅱ Bor/Len 3 正常 否 6 47 男 8 IgGκ Ⅲ A Ⅲ Bor/Len/Ixa 3 RB1缺失 否 7 65 男 12 IgAλ Ⅲ B Ⅲ Bor/Len/Ixa/Dara 3 未测 否 8 57 男 11 IgGκ Ⅲ A Ⅱ Bor/Len 4 1q21扩增、RB1缺失 否 9 73 女 19 IgAλ Ⅲ A Ⅲ Bor/Len/Ixa/Pom/Dara 8 D13S319缺失、1q21缺失 是 10 65 男 36 轻链L Ⅲ B Ⅲ Bor/Len 4 正常 否 DS：Durie-Salmon 分期系统；ISS：国际分期系统；Bor：硼替佐米；Len：来那度胺；Ixa：伊沙佐米；Pom：泊马度胺；Dara：达雷妥尤单抗。 
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表 2 10例RRMM患者塞利尼索用药方案及疗效
序号 治疗方案 最佳疗效 疗程 PFS/月 OS/月 转归 1 Sd SD 3.0 3.0 6.5 死亡 2 SPd VGPR 5.0 5.3 5.3 存活 3 SPd SD 2.0 2.3 4.0 死亡 4 SPd PR 4.0 4.0 7.0 存活 5 Sd PR 4.0 4.0 6.0 死亡 6 SPd CR 6.5 6.5 6.5 存活 7 SPd PR 5.5 5.5 5.5 存活 8 Sd PR 3.0 3.0 11.5 存活 9 SPd SD 2.5 2.5 2.5 死亡 10 SRd PR 4.0 4.6 6.7 存活
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表 3 10例RRMM患者塞利尼索用药不良反应
例(%) 不良反应 总计 1~2级 3~4级 非血液学不良反应 恶心 8(80) 8(80) 0 呕吐 5(50) 4(40) 1(10) 食欲下降 5(50) 4(40) 1(10) 便秘 4(40) 4(40) 0 腹泻 3(30) 3(30) 0 低钠 6(60) 5(50) 1(10) 体重减轻 4(40) 4(40) 0 低钾 1(10) 1(10) 0 肝功异常 1(10) 1(10) 0 高糖 1(10) 1(10) 0 乏力 5(50) 5(50) 0 肺部感染 4(40) 0 4(40) 血液学不良反应 贫血 6(60) 2(20) 4(40) 中性粒细胞减少 7(70) 4(40) 3(30) 血小板减少 8(80) 3(30) 5(50)
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