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达雷妥尤单抗治疗方案在中国新诊断或复发/难治性多发性骨髓瘤患者中的治疗模式、有效性及安全性的真实世界分析

Real-world analysis of treatment patterns, effectiveness, and safety of daratumumab-based regimens in Chinese patients with newly diagnosed or relapsed/refractory multiple myeloma.

作者信息

Wang Luqun, Yang Wei, Wang Yafei, Niu Ting, Fu Rong, Zhong Yuping, Qian Wenbin, Ding Kaiyang, Sun Kai, Liu Hong, Fang Baijun, Liu Hui, Li Yanhui, Yang Yishen, Zhuo Jianmin, Chen Xi, Cui Canchan, Lu Jin

机构信息

Qilu Hospital of Shandong University, Shandong, China.

Shengjing Hospital of China Medical University, Liaoning, China.

出版信息

BMC Cancer. 2025 May 7;25(1):836. doi: 10.1186/s12885-025-13925-3.


DOI:10.1186/s12885-025-13925-3
PMID:40335949
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12057279/
Abstract

BACKGROUND: Daratumumab is a human IgGκ monoclonal antibody targeting CD38 with direct on-tumor and immunomodulatory mechanisms of action. Daratumumab-based treatment is a standard of care for multiple myeloma (MM) based on data from randomized controlled trials. Real-world studies, such as that presented here from China, provide important data to complement randomized trials. METHODS: This ongoing observational study describes real-world treatment patterns and outcomes among patients with symptomatic, newly diagnosed or relapsed/refractory MM treated with daratumumab in China. Patients must have received ≤ 3 prior lines of MM therapy. Data were collected prospectively and/or retrospectively, depending on time of treatment initiation. The primary study objective was to describe treatment patterns and clinical outcomes, and the secondary objective was to assess the safety and tolerability of daratumumab treatment. RESULTS: As of the cutoff date (April 30, 2023) for this analysis, 212 patients had received ≥ 1 dose of daratumumab at 13 sites in China. Regimens included daratumumab monotherapy (n = 22) and daratumumab combined with dexamethasone only (n = 21), proteasome inhibitors (PIs) ± dexamethasone (n = 57), immunomodulatory drugs (IMiDs) ± dexamethasone (n = 72), PIs and IMiDs ± dexamethasone (n = 29), and other combinations (n = 11). Daratumumab was initiated by 16.5%, 53.3%, 16.5%, and 13.7% of patients across the first, second, third, and fourth lines of therapy, respectively. A best overall response of partial response or better was achieved by 71.8% of evaluable patients and very good partial response or better was achieved by 51.4% of patients. Estimated 6-month and 12-month progression-free survival rates were 84.3% and 75.0%, respectively. Outcomes were generally more favorable with daratumumab-based combinations than with daratumumab monotherapy. Serious treatment-emergent adverse events were reported in 13.7% of patients, with pneumonia (4.7%) the only serious event in ≥ 5 patients. The most frequently reported adverse drug reactions were leukopenia (6.6%), neutropenia (5.7%), and thrombocytopenia (5.7%). CONCLUSIONS: This observational study provides real-world insights into treatment decisions for Chinese patients with MM. The effectiveness and safety results support the use of daratumumab-based treatment as a standard-of-care therapy in Chinese patients with newly diagnosed or relapsed/refractory MM. This study is ongoing, with continued collection of outcomes data during a longer follow-up.

摘要

背景:达雷妥尤单抗是一种靶向CD38的人IgGκ单克隆抗体,具有直接的抗肿瘤和免疫调节作用机制。基于随机对照试验的数据,以达雷妥尤单抗为基础的治疗是多发性骨髓瘤(MM)的标准治疗方案。来自中国等的真实世界研究提供了重要数据以补充随机试验。 方法:这项正在进行的观察性研究描述了在中国接受达雷妥尤单抗治疗的有症状、新诊断或复发/难治性MM患者的真实世界治疗模式和结局。患者此前接受的MM治疗必须≤3线。根据治疗开始时间,前瞻性和/或回顾性收集数据。主要研究目标是描述治疗模式和临床结局,次要目标是评估达雷妥尤单抗治疗的安全性和耐受性。 结果:截至本次分析的截止日期(2023年4月30日),中国13个地点的212例患者接受了≥1剂达雷妥尤单抗。治疗方案包括达雷妥尤单抗单药治疗(n = 22)、达雷妥尤单抗仅联合地塞米松(n = 21)、蛋白酶体抑制剂(PIs)±地塞米松(n = 57)、免疫调节剂(IMiDs)±地塞米松(n = 72)、PIs和IMiDs±地塞米松(n = 29)以及其他联合方案(n = 11)。分别有16.5%、53.3%、16.5%和13.7%的患者在第1、2、3和4线治疗中开始使用达雷妥尤单抗。71.8%的可评估患者获得了部分缓解或更好的最佳总体缓解,51.4%的患者获得了非常好的部分缓解或更好的缓解。估计6个月和12个月的无进展生存率分别为84.3%和75.0%。与达雷妥尤单抗单药治疗相比,基于达雷妥尤单抗的联合方案的结局总体上更有利。13.7%的患者报告了严重的治疗中出现的不良事件,肺炎(4.7%)是≥5例患者中唯一的严重事件。最常报告的药物不良反应是白细胞减少(6.6%)、中性粒细胞减少(5.7%)和血小板减少(5.7%)。 结论:这项观察性研究为中国MM患者的治疗决策提供了真实世界的见解。有效性和安全性结果支持将基于达雷妥尤单抗的治疗作为中国新诊断或复发/难治性MM患者的标准治疗方案。本研究正在进行中,在更长的随访期间持续收集结局数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/71b7588cdd61/12885_2025_13925_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/7dc84913c251/12885_2025_13925_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/850563cbfe16/12885_2025_13925_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/71b7588cdd61/12885_2025_13925_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/7dc84913c251/12885_2025_13925_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/850563cbfe16/12885_2025_13925_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d99/12057279/71b7588cdd61/12885_2025_13925_Fig3_HTML.jpg

相似文献

[1]
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[6]
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[7]
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[10]
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本文引用的文献

[1]
Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.

N Engl J Med. 2024-1-25

[2]
Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye.

Turk J Haematol. 2023-12-5

[3]
Clinical characteristics, treatment patterns, and outcomes among African American and White patients with multiple myeloma in the United States.

Leuk Lymphoma. 2024-1

[4]
Changing prevalence of chronic hepatitis B virus infection in China between 1973 and 2021: a systematic literature review and meta-analysis of 3740 studies and 231 million people.

Gut. 2023-11-24

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Future Oncol. 2023-10

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Eur J Haematol. 2023-9

[7]
Hepatitis B reactivation in patients with multiple myeloma treated with anti-CD38 monoclonal antibody-based therapies: a pharmacovigilance analysis.

Int J Clin Pharm. 2023-12

[8]
Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Transplant-ineligible Asian Patients With Newly Diagnosed Multiple Myeloma: The Phase 3 OCTANS Study.

Clin Lymphoma Myeloma Leuk. 2023-6

[9]
Real-World Evidence: A Primer.

Pharmaceut Med. 2023-1

[10]
Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of LEPUS.

Clin Lymphoma Myeloma Leuk. 2023-1

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