De Novellis Danilo, Derudas Daniele, Vincelli Donatella, Fontana Raffaele, Della Pepa Roberta, Palmieri Salvatore, Accardi Fabrizio, Rotondo Francesco, Morelli Emanuela, Gigliotta Emilia, Roccotelli Daniela, Marano Luana, Barone Maria Lucia, Cetani Giusy, Esposito Daniela, Lazzaro Antonio, Delle Cave Giuseppe, Serio Bianca, Morini Denise, Porrazzo Marika, Urciuoli Eleonora, Masucci Chiara, Fanelli Fulvia, Rizzo Michela, Arcamone Manuela, Trastulli Fabio, Rocco Stefano, Leone Aldo, Bianco Rosario, Salvatore Flavia, Idato Aurora, Sicari Maria, Tosi Patrizia, Rascato Maria Gabriella, Di Perna Maria, Falcone Antonietta Pia, Morello Lucia, Carlisi Melania, Svanera Gino, Annunziata Mario, Frigeri Ferdinando, Califano Catello, Carella Angelo Michele, Marcacci Gianpaolo, Pane Fabrizio, Risitano Antonio Maria, Giudice Valentina, Botta Ciro, Selleri Carmine
Hematology and Transplant Center, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Salerno, Italy.
Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Baronissi, Italy.
Eur J Haematol. 2025 Jan;114(1):105-114. doi: 10.1111/ejh.14314. Epub 2024 Oct 6.
Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (N = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.
isatuximab是一种新型抗CD38单克隆抗体，已被批准与卡非佐米和地塞米松联合使用（Isa-Kd），用于复发/难治性多发性骨髓瘤（RRMM）患者。由于其最近才应用，关于其在现实世界中的疗效和安全性的报道较少。在这项意大利多中心现实生活观察性回顾性研究中，对103例RRMM患者队列评估了Isa-Kd方案的疗效和安全性。总缓解率（ORR）为85%，其中严格完全缓解（sCR）或完全缓解（CR）占18%，非常好的部分缓解（VGPR）占39%。在研究期间未达到中位无进展生存期（PFS）和总生存期（OS），而1年PFS和OS分别为72%和77%。42%的受试者观察到血液学毒性，24%的病例发生心脏毒性。此外，我们对一线治疗后接受Isa-Kd治疗的患者（N = 69）进行了亚组分析，显示ORR为88%，其中sCR + CR占20%，VGPR占46%，部分缓解（PR）占22%。在该组中，未达到中位PFS和OS，而1年PFS和OS分别为92%和95%。总之，我们的研究证实Isa-Kd是RRMM的一种有效治疗选择，即使在现实生活环境中其安全性也易于管理。
