埃洛珠单抗联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤:对一项多中心、回顾性真实世界经验的扩展随访,321 个病例未纳入对照临床试验。

IF 3.3 4区 医学 Q2 HEMATOLOGY Hematological Oncology Pub Date : 2024-05-31 DOI:10.1002/hon.3290
Enrica Antonia Martino, Salvatore Palmieri, Monica Galli, Daniele Derudas, Roberto Mina, Roberta Della Pepa, Renato Zambello, Ernesto Vigna, Antonella Bruzzese, Silvia Mangiacavalli, Elena Zamagni, Catello Califano, Maurizio Musso, Concetta Conticello, Claudio Cerchione, Giuseppe Mele, Nicola Di Renzo, Massimo Offidani, Giuseppe Tarantini, Gloria Margiotta Casaluci, Angela Rago, Roberto Ria, Giuseppina Uccello, Gregorio Barilà, Gaetano Palumbo, Loredana Pettine, Iolanda Donatella Vincelli, Marino Brunori, Fabrizio Accardi, Valeria Amico, Angela Amendola, Raffaele Fontana, Velia Bongarzoni, Bernardo Rossini, Emilia Cotzia, Alessandro Gozzetti, Rita Rizzi, Nicola Sgherza, Giovanni Reddiconto, Antonio Maroccia, Luca Franceschini, Giuseppe Bertuglia, Davide Nappi, Emiliano Barbieri, Barbara Gamberi, Maria Teresa Petrucci, Francesco Di Raimondo, Antonino Neri, Fortunato Morabito, Pellegrino Musto, Massimo Gentile
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引用次数: 0

摘要

ELOQUENT-3试验证明,对于既往接受过至少两种疗法(包括来那度胺和蛋白酶体抑制剂)治疗的复发性/难治性多发性骨髓瘤(RRMM)患者,与Pd相比,艾洛单抗、泊马度胺和地塞米松(EloPd)联合疗法在疗效和安全性方面更具优势。本研究是对之前发表的接受过 EloPd 治疗的意大利 RRMM 患者队列进行的为期 18 个月的随访更新。这项修订后的分析纳入了在意大利41个中心接受治疗的319名RRMM患者。在中位随访17.7个月后,213名患者(66.4%)出现疾病进展或死亡。中位无进展生存期(PFS)和总生存期(OS)分别为 7.5 个月和 19.2 个月。更新后的多变量分析显示,国际分期系统(ISS)(II和III)晚期和既往接受过达拉单抗治疗的病例的PFS获益幅度均显著下降。相反,国际分期系统(ISS)(II期和III期)晚期和既往接受过2次以上治疗的病例对OS仍有独立的预后影响。主要不良事件包括四分之三级中性粒细胞减少(24.9%)、贫血(13.4%)、淋巴细胞减少(15.5%)和血小板减少(10.7%),而感染率和肺炎率分别为19.3%和8.7%。随着随访时间的延长,中性粒细胞减少症和淋巴细胞减少症的发生率略有上升。总之,我们的真实世界研究仍然证实,EloPd 是治疗 RRMM 的一种安全可行的选择。然而,对于那些暴露于达拉单抗的患者来说,新的治疗策略是可取的。
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Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended follow-up of a multicenter, retrospective real-world experience with 321 cases outside of controlled clinical trials

The ELOQUENT-3 trial demonstrated the superiority of the combination of elotuzumab, pomalidomide, and dexamethasone (EloPd) in terms of efficacy and safety, compared to Pd in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The present study is an 18-month follow-up update of a previously published Italian real-life RRMM cohort of patients treated with EloPd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. After a median follow-up of 17.7 months, 213 patients (66.4%) experienced disease progression or died. Median progression-free survival (PFS) and overall survival (OS) were 7.5 and 19.2 months, respectively. The updated multivariate analysis showed a significant reduction of PFS benefit magnitude both in advanced International Staging System (ISS) (II and III) stages and previous exposure to daratumumab cases. Instead, advanced ISS (II and III) stages and more than 2 previous lines of therapy maintained an independent prognostic impact on OS. Major adverse events included grade three-fourths neutropenia (24.9%), anemia (13.4%), lymphocytopenia (15.5%), and thrombocytopenia (10.7%), while infection rates and pneumonia were 19.3% and 8.7%, respectively. A slight increase in the incidence of neutropenia and lymphocytopenia was registered with longer follow-up. In conclusion, our real-world study still confirms that EloPd is a safe and possible therapeutic choice for RRMM. Nevertheless, novel strategies are desirable for those patients exposed to daratumumab.

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来源期刊
Hematological Oncology
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.
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