The real-world outcomes of multiple myeloma patients treated with daratumumab.
The real-world outcomes of multiple myeloma patients treated with daratumumab.
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DOI：
10.1371/journal.pone.0258487
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Vangsted AJ
中科院分区：
文献类型：
--
作者：
Szabo AG;Klausen TW;Levring MB;Preiss B;Helleberg C;Breinholt MF;Hermansen E;Gjerdrum LMR;Bønløkke ST;Nielsen K;Kjeldsen E;Iversen KF;Teodorescu EM;Dokhi M;Kurt E;Strandholdt C;Andersen MK;Vangsted AJ
大多数患者不能被纳入随机临床试验。我们报告了截至2019年1月1日接受基于达雷妥珠单抗的方案治疗的所有丹麦多发性骨髓瘤（MM）患者的真实结局。回顾性收集了635例接受达雷妥尤单抗治疗的患者的信息，包括治疗线（LOT）、根据国际骨髓瘤工作组建议的血液学缓解、至下次治疗的时间（TNT）和停药原因。基线特征来自经验证的丹麦多发性骨髓瘤登记处（DMMR）。27.7%的患者接受达雷妥尤单抗单药治疗（Da-mono），57.3%的患者接受达雷妥尤单抗与免疫调节药物联合治疗（Da-IMiD），11.2%的患者接受达雷妥尤单抗与蛋白酶体抑制剂联合治疗（Da-PI），3.8%的患者接受其他联合治疗（Da-其他）。达雷妥尤单抗治疗前的中位治疗线数为：Da-mono 5线，Da-IMiD 3线，Da-PI 4线，Da-其他2线。在Da-mono中，总缓解率（ORR）为44.9%，至下次治疗的中位时间（mTNT）为4.9个月。在Da-IMiD中，ORR为80.5%，mTNT为16.1个月。Da-PI组OOR为60.6%，mTNT为5.3个月。在Da-other治疗的患者中，OOR为54.2%，mTNT为5.6个月。在早期LOT中使用达雷妥尤单抗与较长的TNT相关（p<0.0001）。扩增1 q的患者的结局与标准风险患者相当，而t（4;14），t（14;16）或del 17 p的患者结局更差（p = 0.0001）。多变量分析表明，治疗时间（患者在整个病程中接受的所有LOT中达雷妥尤单抗的给药时间）是影响结局的最重要因素（p<0.0001）。接受达雷妥尤单抗治疗的多发性骨髓瘤患者的真实结局比临床试验结果更差。当达雷妥尤单抗与IMID联合使用和在早期批次中使用时，达雷妥尤单抗实现的结局最佳。高风险CA患者的预后较差，但amp 1 q患者的预后与标准风险患者相似。
Most patients cannot be included in randomized clinical trials. We report real-world outcomes of all Danish patients with multiple myeloma (MM) treated with daratumumab-based regimens until 1 January 2019. Information of 635 patients treated with daratumumab was collected retrospectively and included lines of therapy (LOT), hematologic responses according to the International Myeloma Working Group recommendations, time to next treatment (TNT) and the cause of discontinuation of treatment. Baseline characteristics were acquired from the validated Danish Multiple Myeloma Registry (DMMR). Daratumumab was administrated as monotherapy (Da-mono) in 27.7%, in combination with immunomodulatory drugs (Da-IMiD) in 57.3%, in combination with proteasome inhibitors (Da-PI) in 11.2% and in other combinations (Da-other) in 3.8% of patients. The median number of lines of therapy given before daratumumab was 5 for Da-mono, 3 for Da-IMiD, 4 for Da-PI, and 2 for Da-other. In Da-mono, overall response rate (ORR) was 44.9% and median time to next treatment (mTNT) was 4.9 months. In Da-IMiD, ORR was 80.5%, and mTNT was 16.1 months. In Da-PI, OOR was 60.6% and mTNT was 5.3 months. In patients treated with Da-other, OOR was 54,2% and mTNT was 5.6 months. The use of daratumumab in early LOT was associated with longer TNT (p<0.0001). Patients with amplification 1q had outcome comparable to standard risk patients, while patients with t(4;14), t(14;16) or del17p had worse outcome (p = 0.0001). Multivariate analysis indicated that timing of treatment (timing of daratumumab in the sequence of all LOT that the patients received throughout the course of their disease) was the most important factor for outcome (p<0.0001). The real-world outcomes of multiple myeloma patients treated with daratumumab are worse than the results of clinical trials. Outcomes achieved with daratumumab were best when daratumumab was used in combination with IMIDs and in early LOT. Patients with high-risk CA had worse outcomes, but patients with amp1q had similar outcomes to standard-risk patients.
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