A real-life study of daratumumab combinations in newly diagnosed patients with light chain (AL) amyloidosis

IF 3.3 4区医学 Q2 HEMATOLOGY

Hematological Oncology Pub Date : 2024-06-02 DOI:10.1002/hon.3289

Claudia Bellofiore, Pietro Benvenuti, Roberto Mina, Marco Basset, Andrea Foli, Martina Nanci, Mario Nuvolone, Gianluigi Guida, Andrea Attanasio, Roberta Mussinelli, Silvia Mangiacavalli, Claudio Salvatore Cartia, Valeria Masoni, Michele Palumbo, Lorenzo Cani, Stefania Oliva, Ugo Consoli, Concetta Conticello, Francesco Di Raimondo, Luca Arcaini, Sara Bringhen, Giampaolo Merlini, Giovanni Palladini, Paolo Milani

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Abstract

Daratumumab-based regimens are the new standard of care for newly diagnosed patients with AL amyloidosis based on the results of the ANDROMEDA study. However, real-world data on daratumumab efficacy in upfront therapy in unselected patients are scanty. In the framework of a prospective observational study, we investigated the efficacy and safety of daratumumab in 88 newly diagnosed patients, including subjects with IIIb cardiac stage (26%) or myeloma defining events (29%). Daratumumab was administered with bortezomib in 50 (56%) patients, lenalidomide in 31 (35%), and monotherapy in 7 (8%). The rate of serious adverse events was low (16%). The overall hematologic response rate was 75% with 52 (59%) patients attaining at least a very good partial response (VGPR) at six months. Amongst patients evaluable for organ response, the rate of cardiac and renal responses at 6 months was 31% and 21%, respectively. Comparing stage IIIb patients with the remaining ones, the rate of profound hematologic response was not significantly different (≥VGPR 57% vs. 59%, p 0.955) likewise the rate of cardiac (33% vs. 30%, p 0.340) and renal (40% vs. 16%, p 0.908) responses. Daratumumab-based regimens demonstrated to be safe and effective in treatment-naïve AL amyloidosis even in advanced stage disease.

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一项针对新诊断的轻链（AL）淀粉样变性患者的达拉曲单抗联合用药实证研究。

根据ANDROMEDA研究的结果，以达拉单抗为基础的治疗方案是新诊断的AL淀粉样变性患者的新治疗标准。然而，有关达拉土单抗在未入选患者前期治疗中疗效的真实世界数据并不多。在一项前瞻性观察研究的框架内，我们调查了达拉单抗在88例新诊断患者中的疗效和安全性，其中包括IIIb心脏分期（26%）或骨髓瘤定义事件（29%）的受试者。达拉atumumab与硼替佐米联合用药的患者有50例（56%），来那度胺联合用药的患者有31例（35%），单药治疗的患者有7例（8%）。严重不良反应发生率较低（16%）。总体血液学反应率为75%，其中52例（59%）患者在6个月时至少获得了很好的部分反应（VGPR）。在可评估器官反应的患者中，6 个月时心脏和肾脏反应率分别为 31% 和 21%。将IIIb期患者与其余患者进行比较，血液学深度反应率（≥VGPR 57% vs. 59%，P 0.955）与心脏反应率（33% vs. 30%，P 0.340）和肾脏反应率（40% vs. 16%，P 0.908）无显著差异。即使是晚期AL淀粉样变性病，基于达拉土单抗的治疗方案也被证明对治疗无效的AL淀粉样变性病安全有效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hematological Oncology 医学-血液学

CiteScore

4.20

自引率

6.10%

发文量

147

审稿时长

>12 weeks

期刊介绍： Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.