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卡非佐米、来那度胺和地塞米松(KRD)方案用于复发/难治性多发性骨髓瘤患者的真实世界证据。

Real-world evidence of Carfilzomib, Lenalidomide and Dexamethasone (KRD) Scheme in patients with relapsed / refractory multiple myeloma.

作者信息

Garcia-Guiñon Antoni, Charry Paola Andrea, Jimenez María, Sarra Josep, Delgado Izarbe, Segura de la Torre Laura, Santaliestra Marta, Garcia-Pintos Marta, Gonzalez Yolanda, Senin Alicia, Motlló Cristina, Abella Eugènia, Cabezudo Elena, Granell Miquel, Sancho Esther, Herranz María José, Seres Yasmina, Gironella Mercedes, Soler Juan Alfons, Marti-Tutusaus Josep Maria, Ben Azaiz Ran, Fernandez de Larrea Carlos

机构信息

Hematology Department, Hospital Universitari Arnau de Vilanova de Lleida, Av. Rovira Roure, Lleida, 80 | 25198, Spain.

Hematology Department, Hospital Clínic and IDIBAPS, Universitat de Barcelona, Barcelona, Spain.

出版信息

Ann Hematol. 2025 Feb;104(2):1177-1186. doi: 10.1007/s00277-025-06240-1. Epub 2025 Feb 15.

Abstract

Carfilzomib, lenalidomide and dexamethasone (KRd) is still a widely used treatment option for patients with relapsed / refractory multiple myeloma (RRMM). However, there is limited real-world evidence. Here we evaluated the efficacy and safety of KRd in patients with RRMM treated following the standard clinical practice of the hospitals in the Catalan region. This was a retrospective, observational study. The objective response rate (ORR) according to IMWG criteria was the primary endpoint. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). The study planned to include at least 100-150 patients. In total 194 patients were included. Median age was 64 years (range: 40-88) and 56% were male. All patients had received bortezomib. Additionally, 89 patients (46%) had received thalidomide and 29 (15%) lenalidomide. The ORR was 73% (95% CI: 66-79), with 72 patients (37%) having ≥ CR. The ORR was influenced by ISS score, number of previous treatments and exposure to lenalidomide. The median PFS was 26 months and 2-years OS rate 70%. The ISS stage and LDH levels were independent prognostic factors of survival. In conclusion, the KRd scheme led to a good effectiveness comparable safety profile to the phase III clinical trial in patients with RRMM.

摘要

卡非佐米、来那度胺和地塞米松(KRd)仍是复发/难治性多发性骨髓瘤(RRMM)患者广泛使用的治疗方案。然而,真实世界的证据有限。在此,我们评估了KRd在加泰罗尼亚地区医院按照标准临床实践治疗的RRMM患者中的疗效和安全性。这是一项回顾性观察研究。根据国际骨髓瘤工作组(IMWG)标准的客观缓解率(ORR)是主要终点。次要终点包括无进展生存期(PFS)和总生存期(OS)。该研究计划纳入至少100 - 150例患者。总共纳入了194例患者。中位年龄为64岁(范围:40 - 88岁),56%为男性。所有患者均接受过硼替佐米治疗。此外,89例患者(46%)接受过沙利度胺治疗,29例(15%)接受过来那度胺治疗。ORR为73%(95%CI:66 - 79),72例患者(37%)达到≥完全缓解(CR)。ORR受国际分期系统(ISS)评分、既往治疗次数和来那度胺暴露情况影响。中位PFS为26个月,2年总生存率为70%。ISS分期和乳酸脱氢酶(LDH)水平是生存的独立预后因素。总之,KRd方案在RRMM患者中产生了良好的疗效,安全性与III期临床试验相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6b9b/11971156/f008d2dcd0fe/277_2025_6240_Fig1_HTML.jpg

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