• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

在复发多发性骨髓瘤中,对伊沙妥昔单抗联合卡非佐米和地塞米松与达雷妥尤单抗联合来那度胺和地塞米松的匹配调整间接比较。

Matching-adjusted indirect comparison of isatuximab plus carfilzomib and dexamethasone with daratumumab plus lenalidomide and dexamethasone in relapsed multiple myeloma.

机构信息

Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Sanofi, Cambridge, Massachusetts, USA.

出版信息

Cancer Med. 2023 Apr;12(7):8005-8017. doi: 10.1002/cam4.5584. Epub 2023 Feb 1.

DOI:10.1002/cam4.5584
PMID:36726287
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10134287/
Abstract

BACKGOUND

Lenalidomide-based regimens are commonly used for early relapse in patients with relapsed and/or refractory multiple myeloma (RRMM) receiving at least one prior line of therapy. In the absence of head-to-head comparison, matching-adjusted indirect comparison (MAIC) was conducted to demonstrate efficacy and safety of isatuximab+carfilzomib+dexamethasone (Isa-Kd) versus daratumumab + lenalidomide + dexamethasone (Dara-Rd) in RRMM.

METHODS

Patient-level data from IKEMA trial (Isa-Kd, n = 179) were matched to aggregate data from POLLUX (Dara-Rd, n = 286). Hazard ratios (HR) and 95% confidence intervals (CI) for progression-free survival (PFS) and overall survival (OS) were generated by weighted Cox proportional hazard models. Odds ratios (OR), 95% CI, and p-value were calculated for ≥very good partial response (≥VGPR) and treatment-emergent adverse events (TEAEs).

RESULTS

After matching, no significant differences were observed between Isa-Kd and Dara-Rd in baseline characteristics except for patients with >3 prior lines (0.0% vs. 4.9%). Isa-Kd showed significantly better PFS (HR [95% CI]: 0.46 [0.24-0.86]; p = 0.0155), statistically non-significant improvement favoring Isa-Kd in OS (0.47 [0.20-1.09]; 0.0798), and ≥VGPR (OR [95% CI]: 1.53 [0.89-2.64]; p = 0.1252) than Dara-Rd. Odds of occurrence were significantly lower for some all-grade and grade 3/4 TEAEs with Isa-Kd than Dara-Rd.

CONCLUSION

These results support Isa-Kd as an efficacious treatment for early relapse in non-lenalidomide refractory patients.

摘要

背景

在接受至少一线治疗的复发/难治性多发性骨髓瘤(RRMM)患者中,基于来那度胺的方案常用于早期复发。在没有头对头比较的情况下,采用匹配调整间接比较(MAIC)来证明伊沙佐米+卡非佐米+地塞米松(Isa-Kd)与达雷妥尤单抗+来那度胺+地塞米松(Dara-Rd)在 RRMM 中的疗效和安全性。

方法

从 IKEMA 试验(Isa-Kd,n=179)的患者水平数据中进行匹配,汇总来自 POLLUX(Dara-Rd,n=286)的数据。通过加权 Cox 比例风险模型生成无进展生存期(PFS)和总生存期(OS)的风险比(HR)和 95%置信区间(CI)。计算≥非常好的部分缓解(≥VGPR)和治疗中出现的不良事件(TEAEs)的比值比(OR)、95%CI 和 p 值。

结果

匹配后,除了有>3 条既往治疗线的患者(0.0%对 4.9%)外,Isa-Kd 和 Dara-Rd 在基线特征方面没有显著差异。Isa-Kd 表现出显著更好的 PFS(HR [95%CI]:0.46 [0.24-0.86];p=0.0155),OS 方面有统计学上非显著的获益倾向于 Isa-Kd(0.47 [0.20-1.09];0.0798),以及≥VGPR(OR [95%CI]:1.53 [0.89-2.64];p=0.1252)。与 Dara-Rd 相比,Isa-Kd 发生某些全级和 3/4 级 TEAEs 的可能性显著降低。

结论

这些结果支持 Isa-Kd 作为非来那度胺难治性患者早期复发的有效治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b22e/10134287/b91b4f95a6ea/CAM4-12-8005-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b22e/10134287/b91b4f95a6ea/CAM4-12-8005-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b22e/10134287/b91b4f95a6ea/CAM4-12-8005-g002.jpg

相似文献

1
Matching-adjusted indirect comparison of isatuximab plus carfilzomib and dexamethasone with daratumumab plus lenalidomide and dexamethasone in relapsed multiple myeloma.在复发多发性骨髓瘤中,对伊沙妥昔单抗联合卡非佐米和地塞米松与达雷妥尤单抗联合来那度胺和地塞米松的匹配调整间接比较。
Cancer Med. 2023 Apr;12(7):8005-8017. doi: 10.1002/cam4.5584. Epub 2023 Feb 1.
2
Isatuximab Plus Carfilzomib and Dexamethasone Versus Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: IKEMA Subgroup Analysis by Prior Transplantation.依鲁替尼联合卡非佐米和地塞米松与卡非佐米和地塞米松治疗复发多发性骨髓瘤患者:IKEMA 亚组分析(按既往移植情况)。
Transplant Cell Ther. 2023 Feb;29(2):134.e1-134.e7. doi: 10.1016/j.jtct.2022.11.005. Epub 2022 Nov 11.
3
Isatuximab plus carfilzomib and dexamethasone in patients with early late relapsed multiple myeloma: IKEMA subgroup analysis.伊沙佐米联合卡非佐米和地塞米松治疗早期和晚期复发多发性骨髓瘤患者:IKEMA 亚组分析。
Haematologica. 2024 Feb 1;109(2):604-616. doi: 10.3324/haematol.2023.283073.
4
Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma: IKEMA subgroup analysis.依鲁替尼联合卡非佐米和地塞米松治疗复发/难治性多发性骨髓瘤的疗效观察:IKEMA 亚组分析
Int J Hematol. 2022 Oct;116(4):553-562. doi: 10.1007/s12185-022-03378-w. Epub 2022 May 17.
5
Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis.依沙佐米联合卡非佐米和地塞米松与卡非佐米和地塞米松治疗复发/难治性多发性骨髓瘤老年患者的疗效:IKEMA 亚组分析。
Hematol Oncol. 2022 Dec;40(5):1020-1029. doi: 10.1002/hon.3038. Epub 2022 Jun 8.
6
Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma.伊沙佐米联合卡非佐米和地塞米松治疗复发多发性骨髓瘤的反应深度和反应动力学。
Blood Adv. 2022 Aug 9;6(15):4506-4515. doi: 10.1182/bloodadvances.2021006713.
7
Daratumumab with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients - real world evidence analysis.达雷妥尤单抗联合来那度胺和地塞米松治疗复发或难治性多发性骨髓瘤患者的真实世界证据分析。
Ann Hematol. 2023 Jun;102(6):1501-1511. doi: 10.1007/s00277-023-05188-4. Epub 2023 Apr 24.
8
Carfilzomib, daratumumab, and dexamethasone (KdD) vs. lenalidomide-sparing pomalidomide-containing triplet regimens for relapsed/refractory multiple myeloma: an indirect treatment comparison.卡非佐米、达雷妥尤单抗和地塞米松(KdD)与来那度胺保留的泊马度胺三联方案治疗复发/难治性多发性骨髓瘤的比较:一项间接治疗比较。
Leuk Lymphoma. 2024 Apr;65(4):481-492. doi: 10.1080/10428194.2023.2300051. Epub 2024 Feb 12.
9
Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice.在常规临床实践中,来那度胺和地塞米松(Rd)与伊沙佐米、来那度胺和地塞米松(IRD)相比,对复发和难治性多发性骨髓瘤患者的生存获益。
BMC Cancer. 2021 Jan 15;21(1):73. doi: 10.1186/s12885-020-07732-1.
10
Isatuximab, carfilzomib and dexamethasone (Isa-Kd) for the management of relapsed multiple myeloma.依沙佐米、卡非佐米和地塞米松(Isa-Kd)治疗多发性骨髓瘤复发。
Future Oncol. 2021 Dec;17(35):4849-4860. doi: 10.2217/fon-2021-0778. Epub 2021 Sep 23.

引用本文的文献

1
Lenalidomide based triplets in relapsed/refractory multiple myeloma: analysis of the Czech Myeloma Group.来那度胺为基础的三联疗法用于复发/难治性多发性骨髓瘤:捷克骨髓瘤研究组的分析
BMC Cancer. 2025 Apr 9;25(1):651. doi: 10.1186/s12885-025-14087-y.
2
Cost-effectiveness of edaravone dexborneol versus dl-3-n-butylphthalide for the treatment of acute ischemic stroke: a Chinese health care perspective.依达拉奉右莰醇与丁苯酞治疗急性缺血性脑卒中的成本-效果分析:基于中国医疗保健视角。
BMC Public Health. 2024 Feb 12;24(1):436. doi: 10.1186/s12889-024-17959-3.

本文引用的文献

1
Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma.在治疗复发或难治性多发性骨髓瘤患者的 CARTITUDE-1 研究中比较 cilta-cabtagene autoleucel 与 idecabtagene vicleucel 的疗效结局的匹配调整间接比较。
Curr Med Res Opin. 2021 Oct;37(10):1779-1788. doi: 10.1080/03007995.2021.1953456. Epub 2021 Jul 23.
2
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.isatuximab、卡非佐米和地塞米松用于复发多发性骨髓瘤(IKEMA):一项多中心、开放标签、随机3期试验
Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.
3
When and How to Treat Relapsed Multiple Myeloma.何时以及如何治疗复发性多发性骨髓瘤。
Am Soc Clin Oncol Educ Book. 2021 Mar;41:358-375. doi: 10.1200/EDBK_320129.
4
A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab.isatuximab单药治疗对达雷妥尤单抗难治的多发性骨髓瘤患者的2期研究。
Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4.
5
Matching adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel (ide-cel, bb2121) versus selinexor + dexamethasone and belantamab mafodotin in relapsed and refractory multiple myeloma.在复发和难治性多发性骨髓瘤中,idecabtagene vicleucel(ide-cel,bb2121)与 selinexor + 地塞米松和 belantamab mafodotin 的疗效结局的匹配调整间接比较。
Leuk Lymphoma. 2021 Oct;62(10):2482-2491. doi: 10.1080/10428194.2021.1913143. Epub 2021 Apr 24.
6
Multiple myeloma.多发性骨髓瘤。
Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5.
7
Recent Advances in the Treatment of Patients with Multiple Myeloma.多发性骨髓瘤患者治疗的最新进展
Cancers (Basel). 2020 Nov 30;12(12):3576. doi: 10.3390/cancers12123576.
8
Shaping the Treatment Paradigm Based on the Current Understanding of the Pathobiology of Multiple Myeloma: An Overview.基于当前对多发性骨髓瘤病理生物学的理解塑造治疗模式:概述
Cancers (Basel). 2020 Nov 23;12(11):3488. doi: 10.3390/cancers12113488.
9
Monoclonal Antibodies to Treat Multiple Myeloma: A Dream Come True.用于治疗多发性骨髓瘤的单克隆抗体:梦想成真。
Int J Mol Sci. 2020 Nov 1;21(21):8192. doi: 10.3390/ijms21218192.
10
Performance of unanchored matching-adjusted indirect comparison (MAIC) for the evidence synthesis of single-arm trials with time-to-event outcomes.无锚定匹配调整间接比较(MAIC)在时间事件结局的单臂试验证据综合中的性能。
BMC Med Res Methodol. 2020 Sep 29;20(1):241. doi: 10.1186/s12874-020-01124-6.